Selectra Pro XS, Flexor EL80 Manual Configuración de Reactivos

APPLICATIONS

SEPPIM S.A.S

Zone industrielle 61500 SEES FRANCE :

+33 (0)2 33 81 21 00

 :

+33 (0)2 33 28 77 81

Version: CAT-1 May 2009

AA-PROXS/EL80-CAT-1

BIOCHEMISTRY AC ACIDPHOSPHATASE ALB ALBUMIN ALP ALP(DE (DEA)SL One-reagen agent proce rocedure ALP ALP(DE (DEA)SL Two-re o-reag agent ent proce rocedure ALP ALP(DE (DEA) ALT ALT/ GPT 4+1 SL One-r ne-rea eage gent proc procedur edure e ALT ALT/ GPT 4+1 SL Two-re o-reag agen ent proce rocedure dure ALT ALT/ GPT AM AMYLASE SL AS AST / GOT 4+1 SL One-re ne-reagen agent proce rocedure dure AS AST / GOT 4+1 SL Two-re o-reag agen ent proce rocedure dure AS AST / GOT

PACI-1 I-1 ALBU-1 PASLmonoono-1 1 PASLbi-1 PALC-1 ALSL4+1 L4+1monoono-1 1 ALSL4+1 L4+1bi-1 -1 ALAT-1 T-1 AMSL-1 L-1 ASSL4+1 L4+1mono-1 o-1 ASSL4+1 L4+1bi-1 bi-1 ASAT-1 T-1

PRO CE CE CE PRO CE CE PRO CE CE CE PRO

B BILIRUBIN TOTAL 4+1 BILIRUBIN DIRECT 4+1

BITO-1 BIDI-1

CE CE

C CALCIUM ARSENAZO CALCIUM OCPC One-reagent procedure CHLORIDE CHOLESTEROL SL CHOLESTEROL CHOLESTEROL HDL SL 2G CHOLESTEROL LDL SL 2G HDL CHOLESTEROL CHOLINESTERASE CK-MB SL One-reagent procedure CK-MB CK NAC SL One-reagent procedure CK NAC COPPER One-reagent procedure CREATININE JAFFE One-reagent procedure CREATININE JAFFE Two-reagent procedure CREATININE PAP SL Two-reagent procedure

CALA-1 CALOmono-1 CHLO-1 CHSL-1 CHOL-1 HDLL-1 LDLL-1 HDLC-1 CHES-1 CMSLmono-1 CKMB-1 CKSLmono-1 CKNA-1 CUIVmono-1 CRCOmono-1 CRCObi-1 CRSLbi-1

CE PRO CE CE PRO CE CE PRO PRO CE PRO CE PRO PRO CE CE CE

GAMMA GT SL One-reagent procedure GAMMA GT SL Two-reagent procedure GAMMA GT GLUCOSE HK SL One-reagent procedure GLUCOSE HK SL Two-reagent procedure GLUCOSE PAP SL GLUCOSE PAP

GASLmono-1 GASLbi-1 GAGT-1 GHSLmono-1 GHSLbi-1 GPSL-1 GLUP-1

CE CE PRO CE CE CE PRO

I IRON FERROZINE

FEFR-1

CE

L LACTATE LDH-L SL Two-reagent procedure LDH-P 4+1 SL One reagent procedure LDH-P 4+1 SL Two reagent procedure LDH-P

LACT-1 LLSLbi-1 LDSL4+1mono-1 LDSL4+1bi-1 LDHP-1

PRO PRO CE CE PRO

M MAGNESIUM CALMAGITE One-re -reagent procedure MAGNESIUM CALMAGITE Two-reagent pr procedure MICROPROTEIN

MAGNmono-1 MAGNbi-1 PRTP-1

CE CE CE

P PHOSPHORUS

PHOS-1

CE

T TOTAL PROTEIN TRIGLYCERIDES MONO SL NE TRIGLYCERIDES

PRTB-1 TGMLN-1 TRIG-1

CE CE PRO

U UREA UV One-reagent procedure UREA UV Two-reagent procedure UREA UV URIC ACID MONO SL URIC ACID SL One-reagent procedure URIC ACID SL Two-reagent procedure URIC ACID

URSLmono-1 URSLbi-1 URUV-1 AUML-1 AUSLmono-1 AUSLbi-1 ACUR-1

CE CE PRO CE CE CE PRO

IAPA-1 IAPB-1 ICRP-1 IHAP-1 HBAC-1 IIGA-1 IIGG-1 IIGM-1 IMAL-1 IORO-1 IPAL-1 ITRF-1

CE CE CE CE CE CE CE CE CE CE CE CE

SPECIFIC PROTEINS

G

AP APOA1 IP AP APOB IP CRP IP HAPTOGLOBIN IP HbA1c IgA IP IgG IP IgM IP µALBUMIN IP OROSOMUCOID IP PREALBUMIN IP TRANSFERRIN IP

CE = In agreement with 98/78/EC directive, these applications have been validated according to our internal specific procedure (PO-12-105) based on Vassault protocols 1. Vassault, A., et al., Protocole de validation de de techniques (Document B, stade 3). Ann. Biol. Clin ., (1986), 44 , 686. 2. Vassault, A., et al., Analyses de biologie médicale: spécifications et normes d'acceptabilité à l'usage de la validation des techniques,. Ann. Biol. Clin . (1999), 57, 685. 3 Evaluation of Precision Performance of Quantitat ive Measurement Methods; Approved Guideline—Second Edition. CLSI (NCCLS) document EP5-A2, vol 24, No. 25, August 2004. 4. Evaluation of the Linearity of the Measurement of Quantitative Procedures: a Statistical Approach; Approved Guideline. CLSI (NCCLS) document EP6-A, vol 23, No. 16, April 2003 5. Method Comparison and Bias estimation Using Patient Samples; Approved Guideline—Second Edition. CLSI (NCCLS) document EP9-A2, vol 22, No. 19, September 2002 6. Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition. CLSI (NCCLS) document EP7-A2, vol 25, No. 27, November 2005 PR0 = PROPOSAL: These applications have been established theoretically. It is advised to check it.

2/123

AC ACID PHOSPHATASE TOTAL AND PROSTATIC Ref :

PACI-0030

18 x 3 mL

Instruction for use :

APPLICATION

Selectra ProXS / Flexor EL80

Ge n e r a l

Sam p l e t y p es

Name

AC ACID PHOSPHATASE

Normal

Ab Abbrev reviate iated d name

PACI

Allowed

Yes

Predilution

No

Code

1 s r e t e m a r a p t s e T

PROPOSAL

0

Mode

Kinetic

Reference values

Wavelength

405

Male

XXX

-

XXX

U/L

Units

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

nm

0

Controls

Concentration limits

0

-

40

U/L

Calibrator name

Control 1

XXX

Control 2

XXX

Control 3

XXX

Correlation Prozone check

No

Ge n e r a l

Correlation factor

1.000

Correlation offset

0.000

U/L

Meas u r em en t

Name

AC ACID PHOSPHATASE

Slope Blank

No

Predilution

No

Delay, min. time

307

0

0 0 106

0 sec

Sample Sample blank 2 s r e t e m a r a p t s e T

No normal volume 20.0

rerun volume* µL

15.0

µl

Reagents Reagent blank

Yes normal volume Reagent addition at - 2.25 minutes (R1) 200

Repeats 3 rerun volume* µL

205

µl

µL

0

µl

Reagent addition at 2.90 minutes (R2) 0

10 823.00

%

Absorbance limits Ab Absorba rbance

0.00 .000

-

3.00 .000

Abs

R. Absorbance

0.000

-

3.000

Abs

R. Abs. deviation

3.000

Abs

0


Alinearity Factor

µL

0

µl

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

0

XXX: Enter data by the user * : For information only

(05/2009)  Modification

from the previous version

AA AA-PR -PROXS/EL /EL80-PA -PACI-1 I-1 3/123

ALBUMIN Ref :

ALBU-0250 ALBU-0600 ALBU-0700

12 x 20 mL 2 x 125 mL 4 x 250 mL



APPLICATION General

Sample types

Name


ALBUMIN

Normal

Abbreviated name

ALB

Allowed

Yes

Code

100

Predilution

No

Mode

End point monochromatic

Reference values

Wavelength

620

nm

0

Male

0

XXX

-

XXX

g/dL

Units

g/dL

Female

XXX

-

XXX

g/dL

Decimals

2

Pediatric

XXX

-

XXX

g/dL

Test repeats

1

Panic

XXX

-

XXX

g/dL

Controls


1.5

Calibrator name

XXX

-

6

g/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

g/dL

Measurement

Name

ALBUMIN

Predilution

No

0

Slope Blank

No

Incubation time

4.5

0 min

0 0

Sample Sample blank

No

0

normal volume


3.0

µL

rerun volume*

Factor

2.0

Absorbance limits

µl



3 rerun volume*

Absorbance

0.100

-

2.000

Abs

R. Absorbance

0.100

-

0.300

Abs

398

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0

Calibration accepted

-

0

Repeats

3

Interval

28

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0

Auto accept calibration Concentration XXX

Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0

FAUX FAUX FAUX FAUX FAUX

 Modification

0

Predilution

Name

N° Used #1 Standard #1 0

0

µl

Reagent addition at 2.90 minutes (R2)

n o i t a r b i l a C

1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-ALBU-1 4/123

ALBUMIN Ref :

ALBU-0250 ALBU-0600 ALBU-0700

12 x 20 mL 2 x 125 mL 4 x 250 mL


APPLICATION


0

0

FAUX

PERFORMANCE DATA Analyti cal range The reagent is linear from 1.5 to 6 g/dL.

Detection limi t Determined according to SFBC protocol, the detection limit is equal to 0.03 g/dL.

Precision Within run reproducibility

N 20 20 20

Level 1 Level 2 Level 3

Between run reproducibility

Mean (g/dL) 2.13 3.30 4.69

CV% 0.6% 0.7% 0.8%


N 20 20 20

Mean (g/dL) 2.11 3.26 4.68

CV% 1.9% 1.8% 1.8%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific XL on 30 human sera samples. The sample concentrations were between 1.42 and 5.96 g/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9987 Linear regression : y= 1.0334 x - 0.12 g/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :No significant interference up to 35 mg/dL. Conjugated bilirubin :No significant interference up to 25 mg/dL. Haemoglobin: Positive bias from 350 mg/dL on normal human serum and from 50 mg/dL on pathological human serum. Turbidity :No significant interference up to 600 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert).

On board stability (refrigerated position) The reagent is stable 4 weeks on analyser without recalibrating.

 Modification


(05/2009) AA-PROXS/EL80-ALBU-1 5/123

ALP (DEA) SL ONE-REAGENT PROCEDURE Ref :

PASL-0400 PASL-0420 PASL-0500

2 x 62.5 mL 4 x 62.5mL 5 x 125 mL



APPLICATION General

Sample types

Name

ALP(DEA) SL

Normal

Abbreviatedname

PASL

Allowed

Yes

Predilution

No

Code


Mode

Kinetic

Wavelength

405

Units

U/L

0

Reference values nm

0

Male

XXX

-

XXX

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls

-

900

U/L

Control 1

XXX


20

Control 2

XXX

Calibrator name

XXX

Control 3

XXX

Prozone check

No

Correlation factor

1.000

Correlation offset

0.000

Correlation

General

U/L

Measurement

Name

ALP(DEA) SL

Predilution

No

Slope Blank

No

Delay, min. time

50

Alinearity

10

rerun volume*

Factor

1.00

3.0

Absorbance limits

0

0 0 133

0 sec

Sample Sample blank

No normal volume


5.0

µL

µl



3 rerun volume* µL

252

Absorbance

0.200

-

3.000

Abs

R. Absorbance

0.200

-

1.100

Abs

R. Abs. deviation

3.000

Abs

µl


0

0

µL

0

µl


µL

0

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1


-

Repeats

3

Interval

7

Auto predilution

No

0 0

0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0

Auto accept calibration Concentration xxx

Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-PASLmono-1 6/123

ALP (DEA) SL ONE-REAGENT PROCEDURE Ref :

PASL-0400 PASL-0420 PASL-0500

2 x 62.5 mL 4 x 62.5mL 5 x 125 mL


APPLICATION


0

0

FAUX

PERFORMANCE DATA Analytical range The reagent is linear from 20 to 900 U/L.

Detection limit Determined according to SFBC protocol, the detection limit is equal to 5 U/L.


N 20 20 20



Mean (U/L) 37 134 720

CV% 1.7% 0.6% 0.6%


N 20 20 20

Mean (U/L) 33 137 711

CV% 4.9% 2.4% 0.9%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific XL on 30 human sera samples. The sample concentrations were between 20 and 1041 U/L. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9998 Linear regression : y= 1.0284 x + 1.5 U/L

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :No significant inteference up to 36 mg/dL. Conjugated bilirubin :No significant interference up to 25 mg/dL. Hemoglobin: No significant interference up to 500 mg/dL Turbidity :No significant interference up to 614 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert).

On board stability (refrigerated position) The working reagent is stable 3 weeks on analyser with a new calibration every week.

 Modification


(05/2009) AA-PROXS/EL80-PASLmono-1 7/123

ALP (DEA) SL TWO-REAGENT PROCEDURE Ref :

PASL-0230 PASL-0400 PASL-0420 PASL-0500



APPLICATION General


4 x 25 mL 2 x 62.5mL 4 x 62.5mL 5 x 125 mL

Sample types

Name

ALP(DEA) SL

Normal

Abbreviatedname

PASL

Allowed

Yes

Code

120

Predilution

No

Mode

Kinetic

Wavelength

405

Units

U/L

0

Reference values nm

0

Male

XXX

-

XXX

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls

-

900

U/L

Control 1

XXX


20

Control 2

XXX

Calibrator name

XXX

Control 3

XXX

Prozone check

No

Correlation factor

1.000

Correlation offset

0.000

Correlation

General

U/L

Measurement

Name

ALP(DEA) SL

Predilution

No

Slope Blank

No

Delay, min. time

50

Alinearity

10

rerun volume*

Factor

1.00

3.0

Absorbance limits

0

0 0 133

0 sec

Sample Sample blank

No normal volume


5.0

µL

µl



3 rerun volume* µL

202

Absorbance

0.200

-

2.000

Abs

R. Absorbance

-0.050

-

0.050

Abs

Substrate depletion

0.100

0

0

µL

0

µl


µL

50

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1


-

Repeats

3

Interval

7

Auto predilution

No

0 0

0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


Abs

µl



%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-PASLbi-1 8/123

ALP (DEA) SL TWO-REAGENT PROCEDURE Ref :


APPLICATION

PASL-0230 PASL-0400 PASL-0420 PASL-0500

4 x 25 mL 2 x 62.5mL 4 x 62.5mL 5 x 125 mL


0

0

FAUX




N 20 20 20



Mean (U/L) 40 147 712

CV% 1.1% 0.6% 0.4%


N 20 20 20

Mean (U/L) 34 149 706

CV% 5.5% 1.4% 1.0%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific XL on 30 human sera samples. The sample concentrations were between 20 and 1041 U/L. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9998 Linear regression : y= 1.038 x - 0.08 U/L

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :No significant inteference up to 36 mg/dL. Conjugated bilirubin :No significant interference up to 25 mg/dL. Hemoglobin: No significant interfeence up to 500 mg/dL Turbidity :No significant interference up to 614 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert).

On board stability (refrigerated position) The reagents are stable 3 weeks on analyser with a new calibration every week.

 Modification


(05/2009) AA-PROXS/EL80-PASLbi-1 9/123

ALP(DEA) Ref :

PALC-0030 PALC-0200

20 x 3 mL 12 x 20 mL



APPLICATION General

Sample types

Name

ALP(DEA)

Abbreviated name

Normal

PALC

Code


PROPOSAL

Mode

Kinetic

Wavelength

405

Allowed

Yes

Predilution

No

0

Reference values nm

0

Male

XXX

-

XXX

U/L

Units

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls


20

Calibrator name

XXX

-

700

U/L

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

U/L

Measurement

Name

ALP(DEA)

Predilution

No

Slope Blank

No

Delay, min. time

50

Alinearity

10

rerun volume*

Factor

1.00

3.0

Absorbance limits

0

0 0 133

0 sec

Sample Sample blank

No normal volume


5.0

µL

µl



3 rerun volume* µL

252

Absorbance

0.200

-

3.000

Abs

R. Absorbance

0.200

-

1.100

Abs

R. Abs. deviation

3.000

Abs

µl


0

0

µL

0

µl


µL

0

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

xxx

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-PALC-1 10/123

ALT / GPT 4+1 SL ONE-REAGENT PROCEDURE Ref :

ALSL-0410 ALSL-0430 ALSL-0510

2 x 62.5 mL 4 x 62.5 mL 5 x 125 mL



APPLICATION General

Sample types

Name

ALT/ GPT4+1 SL

Normal

Abbreviatedname

ALSL

Allowed

Yes

Predilution

No

Code


Mode

Kinetic

Wavelength

340

Units

U/L

0

Reference values nm

0

Male

XXX

-

XXX

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls

-

250

U/L

Control 1

XXX


15

Control 2

XXX

Calibrator name

XXX

Control 3

XXX

Prozone check

No

Correlation factor

1.000

Correlation offset

0.000

Correlation

General

U/L

Measurement

Name

ALT/ GPT4+1 SL

Predilution

No

Slope Blank

No

Delay, min. time

50

Alinearity

20

rerun volume*

Factor

1.00

5.0

Absorbance limits

0

0 0 159

0 sec

Sample Sample blank

No normal volume


30.0

µL

µl



3 rerun volume* µL

300

Absorbance

0.200

-

3.000

Abs

R. Absorbance

0.900

-

1.900

Abs

R. Abs. deviation

0.040

Abs

µl


0

0

µL

0

µl


µL

0

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1


-

Repeats

3

Interval

14

Auto predilution

No

0 0

0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-ALSL4+1mono-1 11/123

ALT / GPT 4+1 SL ONE-REAGENT PROCEDURE Ref :

ALSL-0410 ALSL-0430 ALSL-0510

2 x 62.5 mL 4 x 62.5 mL 5 x 125 mL


APPLICATION


0

0

FAUX


Detection limit Determined according to SFBC protocol, the detection limit is equal to 1.5 U/L.


N 20 20 20



Mean (U/L) 19 47 207

CV% 1.4% 0.6% 0.2%


N 20 20 20

Mean (U/L) 17 50 202

CV% 4.6% 3.0% 2.0%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific E on 30 human sera samples. The sample concentrations were between 4 and 257 U/L. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9978 Linear regression : y= 0.9747 x + 1.6 U/L

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :Negative bias from 15 mg/dL. Conjugated bilirubin :Negative bias from 16 mg/dL. Turbidity :No significant interference up to 600 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert). Note:

Hemolysed sera should not be used since significant haemolysis may increase ALT concentrations because of high levels of ALT in erythrocytes.

On board stability (refrigerated position) The working reagent is stable 2 weeks on analyser without recalibrating.

 Modification


(05/2009) AA-PROXS/EL80-ALSL4+1mono-1 12/123

ALT / GPT 4+1 SL TWO-REAGENT PROCEDURE Ref :


8 x 25 mL 2 x 62.5 mL 4 x 62.5 mL 4 x 55 mL 5 x 125 mL


APPLICATION General


ALSL-0250 ALSL-0410 ALSL-0430 ALSL-0455 ALSL-0510

Sample types

Name

ALT/ GPT4+1 SL

Normal

Abbreviatedname

ALSL

Allowed

Yes

Code

140

Predilution

No

Mode

Kinetic

Wavelength

340

Units

U/L

0

Reference values nm

0

Male

XXX

-

XXX

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls

-

250

U/L

Control 1

XXX


15

Control 2

XXX

Calibrator name

XXX

Control 3

XXX

Prozone check

No

Correlation factor

1.000

Correlation offset

0.000

Correlation

General

U/L

Measurement

Name

ALT/ GPT4+1 SL

Predilution

No

Slope Blank

No

Delay, min. time

50

Alinearity

20

rerun volume*

Factor

1.00

5.0

Absorbance limits

0

0 0 159

0 sec

Sample Sample blank

No normal volume


30.0

µL

µl



3 rerun volume* µL

240

Absorbance

0.100

-

3.000

Abs

R. Absorbance

-0.050

-

0.100

Abs

Substrate depletion

-0.500

0

0

µL

0

µl


µL

60

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1


-

Repeats

3

Interval

28

Auto predilution

No

0 0

0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


Abs

µl



%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-ALSL4+1bi-1 13/123

ALT / GPT 4+1 SL TWO-REAGENT PROCEDURE Ref :


APPLICATION

ALSL-0250 ALSL-0410 ALSL-0430 ALSL-0455 ALSL-0510



0

0

FAUX




N 20 20 20



Mean (U/L) 19 46 211

CV% 2.8% 1.2% 0.4%


N 20 20 20

Mean (U/L) 20 53 217

CV% 3.2% 2.1% 1.2%



Hemolysed sera should not be used since significant haemolysis may increase ALT concentrations because of high levels of ALT in erythrocytes.

On board stability (refrigerated position) The reagents are stable 4 weeks on analyser without recalibrating.

 Modification


(05/2009) AA-PROXS/EL80-ALSL4+1bi-1 14/123

ALT/GPT Ref :

ALAT-0200 ALAT-0400

12 x 20 mL 9 x 50 mL



APPLICATION General

Sample types

Name

ALT/GPT

Abbreviated name

Normal

ALAT

Code


PROPOSAL

Mode

Kinetic

Wavelength

340

Allowed

Yes

Predilution

No

0

Reference values nm

0

Male

XXX

-

XXX

U/L

Units

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls


15

Calibrator name

XXX

-

250

U/L

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

U/L

Measurement

Name

ALT/GPT

Predilution

No

Slope Blank

No

Delay, min. time

77

Alinearity

10

rerun volume*

Factor

1.00

13.0

Absorbance limits

0

0 0 185

0 sec

Sample Sample blank

No normal volume


25.0

µL

µl



3 rerun volume* µL

262

Absorbance

0.200

-

2.500

Abs

R. Absorbance

0.500

-

1.900

Abs

R. Abs. deviation

0.050

Abs

µl


0

0

µL

0

µl


µL

0

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

xxx

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-ALAT-1 15/123

AMYLASE SL Ref :

AMSL-0230 AMSL-0390 AMSL-0400

6 x 20 mL 1 x 50 mL 6 x 50 mL



APPLICATION General

Sample types

Name


AMYLASE SL

Normal

Abbreviated name

AMSL

Allowed

Yes

Code

160

Predilution

No

Mode

Kinetic

Reference values

Wavelength

405

nm

0

Male

0

XXX

-

XXX

U/L

Units

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls


20

Calibrator name

XXX

-

2000

U/L

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

U/L

Measurement

Name

AMYLASE SL

Predilution

No

Slope Blank

No

Delay, min. time

50

Alinearity

10

rerun volume*

Factor

1.00

2.0

Absorbance limits

0

0 0 159

0 sec

Sample Sample blank

No normal volume


3.0

µL

µl



3 rerun volume* µL

301

Absorbance

0.015

-

2.000

Abs

R. Absorbance

0.015

-

0.800

Abs

R. Abs. deviation

3.000

Abs

µl


0

0

µL

0

µl


µL

0

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

28

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-AMSL-1 16/123

AMYLASE SL Ref :

AMSL-0230 AMSL-0390 AMSL-0400

6 x 20 mL 1 x 50 mL 6 x 50 mL


APPLICATION


0

0

FAUX

PERFORMANCE DATA Analyti cal range The reagent is linear from 20 to 2000 U/L.

Detection limi t Determined according to SFBC protocol, the detection limit is equal to 2 U/L.


N 20 20 20



Mean (U/L) 52 154 403

CV% 1.2% 0.7% 0.6%


N 20 20 20

Mean (U/L) 52 156 404

CV% 2.0% 1.1% 2.3%


Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :Negative bias from17 mg/dL on pathological human. No significant interference up to 35 mg/dL on normal human sera. Conjugated bilirubin :Negative bias from 21mg/dL on pathological human. No significant interference up to 25 mg/dL on normal human sera. Haemoglobin: No significant interference up to 400 mg/dL. Turbidity :No significant interference up to 600 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert).


 Modification


(05/2009) AA-PROXS/EL80-AMSL-1 17/123

AST / GOT 4+1 SL ONE-REAGENT PROCEDURE Ref :

ASSL-0410 ASSL-0430 ASSL-0510

2 x 62.5 mL 4 x 62.5 mL 5 x 125 mL



APPLICATION General

Sample types

Name

AST/ GOT 4+1 SL

Normal

Abbreviatedname

ASSL

Allowed

Yes

Predilution

No

Code


Mode

Kinetic

Wavelength

340

Units

U/L

0

Reference values nm

0

Male

XXX

-

XXX

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls

-

250

U/L

Control 1

XXX


10

Control 2

XXX

Calibrator name

XXX

Control 3

XXX

Prozone check

No

Correlation factor

1.000

Correlation offset

0.000

Correlation

General

U/L

Measurement

Name

AST/ GOT 4+1 SL

Predilution

No

Slope Blank

No

Delay, min. time

50

Alinearity

20

rerun volume*

Factor

1.00

5.0

Absorbance limits

0

0 0 159

0 sec

Sample Sample blank

No normal volume


30.0

µL

µl



3 rerun volume* µL

300

Absorbance

0.800

-

3.000

Abs

R. Absorbance

0.500

-

1.900

Abs

R. Abs. deviation

0.040

Abs

µl


0

0

µL

0

µl


µL

0

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1


-

Repeats

3

Interval

14

Auto predilution

No

0 0

0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-ASSL4+1mono-1 18/123

AST / GOT 4+1 SL ONE-REAGENT PROCEDURE Ref :

ASSL-0410 ASSL-0430 ASSL-0510

2 x 62.5 mL 4 x 62.5 mL 5 x 125 mL


APPLICATION


0

0

FAUX




N 20 20 20



Mean (U/L) 19 54 182

CV% 2.1% 2.3% 0.3%


N 20 20 20

Mean (U/L) 20 44 193

CV% 2.0% 2.5% 1.5%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific E on 30 human sera samples. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9984 Linear regression : y= 1.0289 x - 0.6 U/L


Hemolysed sera should not be used since significant haemolysis may increase AST concentrations because of high levels of AST in erythrocytes.


 Modification


(05/2009) AA-PROXS/EL80-ASSL4+1mono-1 19/123

AST / GOT 4+1 SL TWO-REAGENT PROCEDURE Ref :




APPLICATION General


ASSL-0250 ASSL-0410 ASSL-0430 ASSL-0455 ASSL-0510

Sample types

Name

AST/ GOT 4+1 SL

Normal

Abbreviatedname

ASSL

Allowed

Yes

Code

180

Predilution

No

Mode

Kinetic

Wavelength

340

Units

U/L

0

Reference values nm

0

Male

XXX

-

XXX

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls

-

250

U/L

Control 1

XXX


10

Control 2

XXX

Calibrator name

XXX

Control 3

XXX

Prozone check

No

Correlation factor

1.000

Correlation offset

0.000

Correlation

General

U/L

Measurement

Name

AST/ GOT 4+1 SL

Predilution

No

Slope Blank

No

Delay, min. time

50

Alinearity

20

rerun volume*

Factor

1.00

5.0

Absorbance limits

0

0 0 159

0 sec

Sample Sample blank

No normal volume


30.0

µL

µl



3 rerun volume* µL

240

Absorbance

0.100

-

3.000

Abs

R. Absorbance

-0.050

-

0.100

Abs

Substrate depletion

-0.500

0

0

µL

0

µl


µL

60

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1


-

Repeats

3

Interval

28

Auto predilution

No

0 0

0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


Abs

µl



%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-ASSL4+1bi-1 20/123

AST / GOT 4+1 SL TWO-REAGENT PROCEDURE Ref :


APPLICATION

ASSL-0250 ASSL-0410 ASSL-0430 ASSL-0455 ASSL-0510



0

0

FAUX




N 20 20 20



Mean (U/L) 21 46 208

CV% 1.7% 0.9% 0.8%


N 20 20 20

Mean (U/L) 20 46 206

CV% 2.7% 2.9% 2.0%



Hemolysed sera should not be used since significant haemolysis may increase AST concentrations because of high levels of AST in erythrocytes.


 Modification


(05/2009) AA-PROXS/EL80-ASSL4+1bi-1 21/123

AST/GOT Ref :

ASAT-0200 ASAT-0400

12 x 20 mL 9 x 50 mL



APPLICATION General

Sample types

Name

AST/GOT

Abbreviated name

Normal

ASAT

Code


PROPOSAL

Mode

Kinetic

Wavelength

340

Allowed

Yes

Predilution

No

0

Reference values nm

0

Male

XXX

-

XXX

U/L

Units

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls


15

Calibrator name

XXX

-

250

U/L

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

U/L

Measurement

Name

AST/GOT

Predilution

No

Slope Blank

No

Delay, min. time

77

Alinearity

10

rerun volume*

Factor

1.00

13.0

Absorbance limits

0

0 0 185

0 sec

Sample Sample blank

No normal volume


25.0

µL

µl



3 rerun volume* µL

262

Absorbance

0.200

-

2.500

Abs

R. Absorbance

0.900

-

1.900

Abs

R. Abs. deviation

0.050

Abs

µl


0

0

µL

0

µl


µL

0

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

xxx

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-ASAT-1 22/123

BILIRUBIN TOTAL 4+1 Ref :

BITO-0600 BITD-0600 BITO-0250

2 x 125 mL 2 x 125 mL 8 x 25 mL



APPLICATION General


Sample types

Name

BILIRUBIN TOTAL 4+1

Normal

Abbreviatedname

BITO

Allowed

Yes

Code

220

Predilution

No

Mode


Wavelength

546

Units

mg/dL

0

Reference values

nm

0

Male

XXX

-

XXX

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

2

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls

-

20

mg/dL

Control 1

XXX


0.3

Control 2

XXX

Calibrator name

XXX

Control 3

XXX

Prozone check

No

Correlation factor

1.000

Correlation offset

0.000

Correlation

General

mg/dL

Measurement

Name

BILIRUBIN TOTAL 4+1

Slope Blank

No

Predilution

No

Incubation time

6.5

0

0 min

0 0

Sample Sample blank

No

0

normal volume


30.0

µL

rerun volume*

Factor

10.0

Absorbance limits

µl



3 rerun volume*

Absorbance

-0.010

-

2.500

Abs

R. Absorbance

-0.010

-

0.050

Abs

240

9.000

0

0

µL

0

µl


µL

60

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1


-

Repeats

3

Interval

14

Auto predilution

No

0 0

0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0

Auto accept calibration



0

Predilution

Name


0

µl



1.00

0 µL

0

Concentration xxx

Yes 0 0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


Modification from the previous version

0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-BITO-1 23/123

BILIRUBIN TOTAL 4+1 Ref :

BITO-0600 BITD-0600 BITO-0250

2 x 125 mL 2 x 125 mL 8 x 25 mL



APPLICATION 0

0

FAUX

PREPARATION OF REAGENTS: Position R1: Reagent 1 (Ready to use) Position R3: Reagent 2 (Ready to use)

PERFORMANCE DATA Analytical range The reagent is linear from 0.3 to 20 mg/dL.

Detection limit Determined according to SFBC protocol, the detection limit is equal to 0.04 mg/dL.



N 20 20 20

Mean (mg/dL) 0.82 2.91 9.39


CV% 2.1% 0.4% 0.5%


N 20 20 20

Mean (mg/dL) 0.77 2.78 9.46

CV% 2.4% 3.1% 3.0%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific E on 30 human sera samples. The sample concentrations were between 0.17 and 28.82 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9992 Linear regression : y= 1.0084 x + 0.034 mg/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Turbidity :No significant interference up to 600 mg/dL Triglycerides equivalent. Hemoglobin: No significant interference up to 500 mg/dL. Ascorbic acid: No significant interference up to 20 mg/dL. Other compounds may interfere (see product insert).

On board stability (refrigerated position) The reagents are stable 4 weeks on analyser with a new calibration every 2 weeks.



Modification from the previous version

(05/2009) AA-PROXS/EL80-BITO-1 24/123

BILIRUBIN DIRECT 4+1 Ref :

BITD-0600 BIDI-0600 BIDI-0250

2 x 125 mL 2 x 125 mL 8 x 25 mL



APPLICATION General


Sample types

Name

BILIRUBIN DIRECT 4+1

Normal

Abbreviatedname

BIDI

Allowed

Yes

Code

200

Predilution

No

Mode


Wavelength

546

Units

mg/dL

0

Reference values

nm

0

Male

XXX

-

XXX

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

2

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls

-

18

mg/dL

Control 1

XXX


0.15

Control 2

XXX

Calibrator name

XXX

Control 3

XXX

Prozone check

No

Correlation factor

1.000

Correlation offset

0.000

Correlation

General

mg/dL

Measurement

Name

BILIRUBIN DIRECT 4+1

Slope Blank

No

Predilution

No

Incubation time

6.5

0

0 min

0 0

Sample Sample blank

No

0

normal volume


30.0

µL

rerun volume*

Factor

30.0

Absorbance limits

µl



3 rerun volume*

Absorbance

-0.010

-

2.500

Abs

R. Absorbance

-0.010

-

0.010

Abs

240

9.000

0

0

µL

0

µl


µL

60

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1


-

Repeats

3

Interval

14

Auto predilution

No

0 0

0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-BIDI-1 25/123

BILIRUBIN DIRECT 4+1 Ref :

BITD-0600 BIDI-0600 BIDI-0250

2 x 125 mL 2 x 125 mL 8 x 25 mL



APPLICATION 0

0

FAUX

PREPARATION OF REAGENTS: Position R1: Reagent 1 (Ready to use) Position R3: Reagent 2 (Ready to use)

PERFORMANCE DATA Analytical range The reagent is linear from 0.15 to 18 mg/dL.



N 20 20 20


Mean (mg/dL) 0.85 2.77 9.76


CV% 0.7% 0.6% 0.8%


N 20 20 20

Mean (mg/dL) 0.73 2.63 9.35

CV% 3.5% 1.9% 2.7%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific E on 30 human sera samples. The sample concentrations were between 0.15 and 18.4 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9994 Linear regression : y= 1.0127 x - 0.014 mg/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Turbidity :No significant interference up to 600 mg/dL Triglycerides equivalent. Hemoglobin: Negative bias from 100 mg/dL. Ascorbic acid: Positive bias from 2 mg/dL. Other compounds may interfere (see product insert).


 Modification


(05/2009) AA-PROXS/EL80-BIDI-1 26/123

CALCIUM ARSENAZO Ref :

CALA-0250 CALA-0600

12 x 20 mL 2 x 125 mL



APPLICATION General


Sample types

Name

CALCIUMARSENAZO

Normal

Abbreviated name

CALA

Allowed

Yes

Code

240

Predilution

No

Mode


Reference values

Wavelength

660

nm

0

Male

0

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

1

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


5

Calibrator name

XXX

-

15

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

CALCIUMARSENAZO

Slope Blank

No

Predilution

No

Incubation time

4.5

0

0 min

0 0

Sample Sample blank

No

0

normal volume


6.0

µL

rerun volume*

Factor

6.0

Absorbance limits

µl



3 rerun volume*

Absorbance

0.100

-

2.500

Abs

R. Absorbance

0.050

-

1.000

Abs

300

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

28

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-CALA-1 27/123

CALCIUM ARSENAZO Ref :

CALA-0250 CALA-0600

12 x 20 mL 2 x 125 mL



APPLICATION 0

0

FAUX

PERFORMANCE DATA Analyti cal range The reagent is linear from 5 to 15 mg/dL.

Detection limi t Determined according to SFBC protocol, the detection limit is equal to 0.03 mg/dL.


N 20 20 20


Mean (mg/dL) 7.0 9.4 12.5


CV% 1.0% 0.8% 0.4%


N 20 20 20

Mean (mg/dL) 7.1 9.4 12.3

CV% 1.5% 1.5% 0.7%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific XL on 30 human sera samples. The sample concentrations were between 4.4 and 14.7 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9987 Linear regression : y= 1.0311 x - 0.06 mg/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :Positive bias from 3 mg/dL. Conjugated bilirubin :No significant interference up to 25 mg/dL. Haemoglobin: Positive bias from 450 mg/dL. Turbidity :Positive bias from 400 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert).


 Modification


(05/2009) AA-PROXS/EL80-CALA-1 28/123

CALCIUM OCPC ONE-REAGENT PROCEDURE Ref :

CALO-0600

2 x 125 mL



APPLICATION General

Sample types

Name

CALCIUMOCPC

Normal

Abbreviated name

CALO

Allowed

Yes

Predilution

No

Code


PROPOSAL

Mode

End point bichromatic

Wavelength

578

0

Reference values

nm

620

nm

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

1

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


5

Calibrator name

XXX

-

13.5

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

CALCIUMOCPC

Predilution

No

0

Slope Blank

No

Incubation time

4.5

0 min

0 0

Sample Sample blank

No

0

normal volume


3.0

µL

rerun volume*

Factor

2.0

Absorbance limits

µl



3 rerun volume*

Absorbance

-0.100

-

3.000

Abs

R. Absorbance

-0.100

-

1.200

Abs

301

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

xxx

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-CALOmono-1 29/123

CHLORIDE Ref :

CHLO-0250 CHLO-0600

12 x 20 mL 2 x 125 mL



APPLICATION General


Sample types

Name

CHLORIDE

Normal

Abbreviated name

CHLO

Allowed

Yes

Code

260

Predilution

No

Mode


Reference values

Wavelength

505

nm

0

Male

0

XXX

-

XXX

mEq/L

Units

mEq/L

Female

XXX

-

XXX

mEq/L

Decimals

1

Pediatric

XXX

-

XXX

mEq/L

Test repeats

1

Panic

XXX

-

XXX

mEq/L

Controls


50

Calibrator name

XXX

-

130

mEq/L

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mEq/L

Measurement

Name

CHLORIDE

Predilution

No

0

Slope Blank

No

Incubation time

4.5

0 min

0 0

Sample Sample blank

No

0

normal volume


3.0

µL

rerun volume*

Factor

2.0

Absorbance limits

µl



3 rerun volume*

Absorbance

0.000

-

0.800

Abs

R. Absorbance

0.000

-

0.200

Abs

301

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

7

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0

Auto accept calibration Concentration XXX

Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-CHLO-1 30/123

CHLORIDE Ref :

CHLO-0250 CHLO-0600

12 x 20 mL 2 x 125 mL



APPLICATION 0

0

FAUX

PERFORMANCE DATA Analyti cal range The reagent is linear from 50 to 130 mEq/L.

Detection limi t Determined according to SFBC protocol, the detection limit is equal to 1 mEq/L.


N 20 20 20


Mean (mEq/L) 80.6 107.1 113.8


CV% 0.5% 0.4% 0.3%


N 20 20 19

Mean (mEq/L) 82.5 112.3 117.4

CV% 1.6% 1.5% 1.6%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific XL on 30 human sera samples. The sample concentrations were between 48 and 128.7 mEq/L. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9993 Linear regression : y= 0.9994 x + 0.07 mEq/L

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :No significant interference up to 35 mg/dL on normal human sera. Positive bias from 23 mg/dL on pathological human sera. Conjugated bilirubin :No significant interference up to 25 mg/dL. Haemoglobin: Positive bias from 250 mg/dL Turbidity :Positive bias from 300 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert).

On board stability (refrigerated position) The reagent is stable 4 weeks on analyser with a new calibration every week.

 Modification


(05/2009) AA-PROXS/EL80-CHLO-1 31/123

CHOLESTEROL SL Ref :


12 x 20 mL 6 x 45 mL 1 x 100 mL 6 x 100 mL 4 x 250 mL 6 x 100 mL +STD 4 x 250 mL +STD


APPLICATION General


CHSL-0250 CHSL-0455 CHSL-0490 CHSL-0500 CHSL-0700 CHSL-0507 CHSL-0707

Sample types

Name

CHOLESTEROL SL

Normal

Abbreviated name

CHSL

Allowed

Yes

Code

280

Predilution

No

Mode


Reference values

Wavelength

505

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

nm

0

0

Controls


20

Calibrator name

XXX

-

600

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

CHOLESTEROL SL

Predilution

No

0

Slope Blank

No

Incubation time

4.5

0 min

0 0

Sample Sample blank

No

0

normal volume


3.0

rerun volume* µL

3.0

µl



3 rerun volume*

Factor Absorbance limits Absorbance

0.000

-

2.000

Abs

R. Absorbance

0.000

-

0.150

Abs

0 µL

300

µl

µL

0

µl


9.000


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Auto predilution

Number of standard

1

0


-

0

Repeats

3

Interval

28

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


0

0

0


0 1.00

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-CHSL-1 32/123

CHOLESTEROL SL Ref :

CHSL-0250 CHSL-0455 CHSL-0490 CHSL-0500 CHSL-0700 CHSL-0507 CHSL-0707


12 x 20 mL 6 x 45 mL 1 x 100 mL 6 x 100 mL 4 x 250 mL 6 x 100 mL +STD 4 x 250 mL +STD


APPLICATION 0

0

FAUX

PERFORMANCE DATA Analytical range The reagent is linear from 20 to 600 mg/dL.

Detection limit Determined according to SFBC protocol, the detection limit is equal to 2 mg/dL.


N 20 20 20


Mean (mg/dL) 115 188 296


CV% 2.4% 1.6% 1.3%


N 20 20 20

Mean (mg/dL) 114 187 292

CV% 1.4% 2.1% 2.2%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific E on 31 human sera samples. The sample concentrations were between 9 and 626 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9993 Linear regression : y= 1.0351 x - 4 mg/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :Negative bias from 30 mg/dL. Conjugated bilirubin :No significant interference up to 25 mg/dL. Haemoglobin: No significant interference up to 500 mg/dL. Turbidity :No significant interference up to 600 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert).


 Modification


(05/2009) AA-PROXS/EL80-CHSL-1 33/123

CHOLESTEROL Ref :

CHOL-0220 CHOL-0420 CHOL-0520 CHOL-0720



APPLICATION General

PROPOSAL

Sample types

Name

CHOLESTEROL

Normal

Abbreviated name

CHOL

Allowed

Yes

Predilution

No

Code


12 x 20 mL 9 x 50 mL 6 x 100 mL 4 x 250 mL

Mode


Wavelength

505

0

Reference values

nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


20

Calibrator name

XXX

-

500

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

CHOLESTEROL

Predilution

No

0

Slope Blank

No

Incubation time

4.5

0 min

0 0

Sample Sample blank

No

0

normal volume


3.0

µL

rerun volume*

Factor

2.0

Absorbance limits

µl



3 rerun volume*

Absorbance

-0.100

-

1.500

Abs

R. Absorbance

-0.100

-

0.300

Abs

301

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

xxx

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-CHOL-1 34/123

CHOLESTEROL HDL SL 2G Ref :

HDLL-0230 HDLL-0380 HDLL-0390



APPLICATION General


4 x 28 mL 1 x 80 mL 3 x 80 mL

Sample types

Name

CHOLESTEROL HDL SL 2G

Normal

Abbreviated name

HDLL

Allowed

Yes

Code

340

Predilution

No

Mode

Two point

Reference values

Wavelength

578

nm

0

Male

0

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

1

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


5.0

Calibrator name

XXX

-

200.0

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

CHOLESTEROL HDL SL 2G

Slope Blank

No

Predilution

No

Point one, two

-3

0

0 0 236

0 sec

Sample Sample blank

No

0

normal volume


2.4

µL

rerun volume*

Factor

2.4

Absorbance limits

µl



3 rerun volume* µL

240

1.00

Absorbance

-0.010

-

1.000

Abs

R. Absorbance

-0.010

-

0.010

Abs

Substrate depletion

0.000

Abs

µl


0

0

µL

0

µl


µL

80

µl

Calibrator


0

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

Predilution

Name

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

XXX

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0

Auto accept calibration N° Used #1 Standard #1 0

Concentration xxx

Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


Modification

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-HDLL-1 35/123

CHOLESTEROL HDL SL 2G Ref : Instruction for use :

APPLICATION

HDLL-0230 HDLL-0380 HDLL-0390

4 x 28 mL 1 x 80 mL 3 x 80 mL


0

0

FAUX

PERFORMANCE DATA Analyti cal range Determined according to EP6-A protocol of CLSI The reagent is linear from 5 to 200 mg/dL.


Precision Determined according to EP5-A2 protocol of CLSI

N 80 80 80


Mean (mg/dL) 30.8 55.6 87.3

Within-run CV% 1.4% 0.7% 1.4%

Total CV% 3.0% 2.8% 3.3%

Correlation Determined according to EP9-A2 protocol of CLSI. A comparative study has been performed against a concurrent system on 83 human samples. The sample concentrations were between 9.3 and 151 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r): 0.996 Linear regression : y= 1.141 x - 4.0 mg/dL

Interferences According to SFBC recommendations and EP7-A2 protocol of CLSI, studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin: No significant interference up to 616 µmol/L. Conjugated bilirubin: No significant interference up to 427 µmol/L. Turbidity: No significant interference up to 500 mg/dL Triglycerides equivalent. Hemoglobine: No significant interference up to 500 mg/dL. Other compounds may interfere. (see product insert)

On board stability (refrigerated position) The reagents are stable 3 weeks on analyser. A new calibration is required when the quality control result are outside expected specification. To increase the calibration stability, it is recommended to close the vials when they are not used.

Modification


(05/2009) AA-PROXS/EL80-HDLL-1 36/123

CHOLESTEROL LDL SL 2G Ref :

LDLL-0230 LDLL-0380

4 x 28 mL 1 x 80 mL



APPLICATION General


Sample types

Name

CHOLESTEROL LDL SL 2G

Normal

Abbreviated name

LDLL

Allowed

Yes

Code

360

Predilution

No

Mode

Two point

Reference values

Wavelength

578

nm

0

Male

0

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

1

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


15

Calibrator name

XXX

-

700.0

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

CHOLESTEROL LDL SL 2G

Slope Blank

No

Predilution

No

Point one, two

-3

0

0 0 236

0 sec

Sample Sample blank

No

0

normal volume


2.4

µL

rerun volume*

Factor

2.4

Absorbance limits

µl



3 rerun volume* µL

240

1.00

Absorbance

-0.010

-

2.000

Abs

R. Absorbance

-0.010

-

0.020

Abs

Substrate depletion

0.000

Abs

µl


0

0

µL

0

µl


µL

80

µl

Calibrator


0

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

Predilution

Name

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

21

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Concentration xxx

Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


Modification

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-LDLL-1 37/123

CHOLESTEROL LDL SL 2G Ref :

LDLL-0230 LDLL-0380

4 x 28 mL 1 x 80 mL


APPLICATION


0

0

FAUX

PERFORMANCE DATA Analyti cal range Determined according to EP6-A protocol of CLSI The reagent is linear from 15 to 700 mg/dL.



N 80 80 80


Mean (mg/dL) 101.9 121.4 161.7

Within-run CV% 1.8% 1.3% 1.9%

Total CV% 3.4% 2.3% 3.3%

Correlation Determined according to EP9-A2 protocol of CLSI. A comparative study has been performed against a concurrent system on 60 human samples. The sample concentrations were between 14.7 and 352.1 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) : 0.985 Linear regression : y= 0.937 x + 9.4 mg/dL

Interferences According to SFBC recommendations and EP7-A2 protocol of CLSI, studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin: No significant interference up to 513 µmol/L. Conjugated bilirubin: No significant interference up to 359 µmol/L. Turbidity: No significant interference up to 600 mg/dL Triglycerides equivalent. Hemoglobine: No significant interference up to 500 mg/dL. Other compounds may interfere (see product insert)


Modification


(05/2009) AA-PROXS/EL80-LDLL-1 38/123

HDL CHOLESTEROL Ref :

HDLC-0060 HDLC-0520

3 x 10 mL 3 x 100 mL



APPLICATION General

Sample types

Name

HDL CHOLESTEROL

Normal

Abbreviated name

HDLC

Allowed

Yes

Predilution

No

Code


PROPOSAL

Mode


Wavelength

505

0

Reference values

nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


0

Calibrator name

XXX

-

200

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

HDL CHOLESTEROL

Predilution

No

0

Slope Blank

No

Incubation time

4.5

0 min

0 0

Sample Sample blank

No

0

normal volume


15.0

µL

rerun volume*

Factor

10.0

Absorbance limits

µl



3 rerun volume*

Absorbance

0.100

-

2.500

Abs

R. Absorbance

0.000

-

2.000

Abs

305

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

xxx

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-HDLC-1 39/123

CHOLINESTERASE Ref :

CHES-0053

16 x 3 mL



APPLICATION General

Sample types

Name

CHOLINESTERASE

Normal

Abbreviated name

CHES

Allowed

Yes

Predilution

No

Code


PROPOSAL

Mode

Kinetic

Wavelength

405

0

Reference values nm

0

Male

XXX

-

XXX

U/L

Units

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls


1200

Calibrator name

XXX

-

8000

U/L

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

U/L

Measurement

Name

CHOLINESTERASE

Predilution

No

Slope Blank

No

Delay, min. time

24

Alinearity

10

rerun volume*

Factor

1.00

2.4

Absorbance limits

0

0 0 106

0 sec

Sample Sample blank

No normal volume


2.4

µL

µl



3 rerun volume* µL

360

Absorbance

0.000

-

3.000

Abs

R. Absorbance

0.050

-

0.500

Abs

Substrate depletion

3.000

Abs

µl


0

0

µL

0

µl


µL

12

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

xxx

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-CHES-1 40/123

CK-MB SL ONE-REAGENT PROCEDURE Ref :

CMSL-0230 CMSL-0410 CMSL-0430

4 x 25 mL 2 x 62.5 mL 4 x 62.5 mL



APPLICATION General


Sample types

Name

CK-MB SL

Normal

Abbreviated name

CMSL

Allowed

Yes

Code

400

Predilution

No

Mode

Kinetic

Reference values

Wavelength

340

nm

0

Male

0

XXX

-

XXX

U/L

Units

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls


3

-

600

U/L

Calibrator name

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

U/L

Measurement

Name

CK-MB SL

Predilution

No

Slope Blank

No

Delay, min. time

130

Alinearity

10

rerun volume*

Factor

7949.00

5.0

Absorbance limits

0

0 0 159

0 sec



µL

µl




255

0.000

-

1.500

Abs

R. Absorbance

0.000

-

1.000

Abs

R. Abs. deviation

3.000

Abs

0 µL

0

µl


Absorbance

µl


%

µL

0

µl

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

0


Modification


(05/2009) AA-PROXS/EL80-CMSLmono-1 41/123

CK-MB SL ONE-REAGENT PROCEDURE Ref :

CMSL-0230 CMSL-0410 CMSL-0430

4 x 25 mL 2 x 62.5 mL 4 x 62.5 mL


APPLICATION





N 20 20 20



Mean (U/L) 29 78 146

CV% 2.0% 1.4% 0.7%


N 20 20 20

Mean (U/L) 26 72 144

CV% 4.7% 3.7% 2.7%


Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :Negative bias from 9 mg/dL on normal human sera and from 15 mg/dL on pathological human sera. Conjugated bilirubin :Negative bias from 2 mg/dL on normal human sera and from 6 mg/dL on pathological human sera. Turbidity No significant interference up to 600 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert). NOTE:

1. Hemolysed sera should not be used since significant hemolysis may increase CK-MB concentration because of adenylate kinase release. 2. The method will also measure any CK-BB isoenzyme present in serum alone or complexed with i mmunoglobulins (macro-CK). The activity of the isoenzyme is usually negligible, however, if a significant amount of CK-BB activity is present the CK-MB activity will be overestimated.

On board stability (refrigerated position) The working reagent is stable 2 weeks on analyser.

Modification


(05/2009) AA-PROXS/EL80-CMSLmono-1 42/123

CK-MB Ref :

CKMB-0030

20 x 3 mL


APPLICATION


General

Sample types

Name

CK-MB

Normal

Abbreviated name

CKMB

Allowed

Yes

Predilution

No

Code


PROPOSAL

0

Mode

Kinetic

Reference values

Wavelength

340

Male

XXX

-

XXX

U/L

Units

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

nm

0

Controls


20

-

600

U/L

Calibrator name

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

U/L

Measurement

Name

CK-MB

Predilution

No

0

Slope Blank

No

Delay, min. time

103

0 0 159

0 sec



rerun volume* µL

7.0

µl




266

µl

µL

0

µl


10 6422

%

Absorbance limits Absorbance

0.000

-

2.000

Abs

R. Absorbance

0.000

-

0.900

Abs

R. Abs. deviation

3.000

Abs

0


Alinearity Factor

µL

0

µl

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

0


 Modification


(05/2009) AA-PROXS/EL80-CKMB-1 43/123

CK NAC SL ONE-REAGENT PROCEDURE Ref :

CKSL-0230 CKSL-0410 CKSL-0430

4 x 25 mL 2 x 62.5 mL 4 x 62.5 mL



APPLICATION General


Sample types

Name

CK NAC SL

Normal

Abbreviated name

CKSL

Allowed

Yes

Code

380

Predilution

No

Mode

Kinetic

Reference values

Wavelength

340

nm

0

Male

0

XXX

-

XXX

U/L

Units

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls


8

Calibrator name

XXX

-

1700

U/L

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

U/L

Measurement

Name

CK NAC SL

Predilution

No

Slope Blank

No

Delay, min. time

130

Alinearity

20

rerun volume*

Factor

1.00

4.0

Absorbance limits

0

0 0 159

0 sec

Sample Sample blank

No normal volume


10.0

µL

µl



3 rerun volume* µL

250

Absorbance

0.000

-

3.000

Abs

R. Absorbance

0.000

-

1.000

Abs

R. Abs. deviation

3.000

Abs

µl


0

0

µL

0

µl


µL

0

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

14

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-CKSLmono-1 44/123

CK NAC SL ONE-REAGENT PROCEDURE Ref :

CKSL-0230 CKSL-0410 CKSL-0430

4 x 25 mL 2 x 62.5 mL 4 x 62.5 mL


APPLICATION


0

0

FAUX




N 20 20 20



Mean (U/L) 52 99 476

CV% 0.8% 0.6% 0.7%


N 20 20 20

Mean (U/L) 53 101 496

CV% 2.8% 2.1% 1.3%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific XL on 30 human sera samples. The sample concentrations were between 8 and 1757 U/L. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9997 Linear regression : y= 1.0085 x + 2 U/L

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :Negative bias from17 mg/dL. Conjugated bilirubin :Negative bias from 10 mg/dL. Turbidity :No significant interference up to 600 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert). Note: Hemolysed sera should not be used since significant hemolysis may increase CK concentration because of adenylate kinase release.


 Modification


(05/2009) AA-PROXS/EL80-CKSLmono-1 45/123

CK NAC Ref :

CKNA-0030

20 x 3 mL



APPLICATION General

Sample types

Name

CK NAC

Normal

Abbreviated name

CKNA

Allowed

Yes

Predilution

No

Code


PROPOSAL

Mode

Kinetic

Wavelength

340

0

Reference values nm

0

Male

XXX

-

XXX

U/L

Units

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls


15

Calibrator name

XXX

-

1800

U/L

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

U/L

Measurement

Name

CK NAC

Predilution

No

Slope Blank

No

Delay, min. time

130

Alinearity

10

rerun volume*

Factor

1.00

4.0

Absorbance limits

0

0 0 159

0 sec

Sample Sample blank

No normal volume


5.0

µL

µl



3 rerun volume* µL

251

Absorbance

-0.100

-

2.500

Abs

R. Absorbance

-0.100

-

1.000

Abs

R. Abs. deviation

3.000

Abs

µl


0

0

µL

0

µl


µL

0

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

xxx

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-CKNA-1 46/123

COPPER ONE REAGENT PROCEDURE Ref :

CUIV-0050

5 x 10 mL



APPLICATION General

Sample types

Name

COPPER

Normal

Abbreviated name

CUIV

Allowed

Yes

Predilution

No

Code


PROPOSAL

Mode


Wavelength

578

0

Reference values

nm

0

Male

XXX

-

XXX

µg/dL

Units

µg/dL

Female

XXX

-

XXX

µg/dL

Decimals

0

Pediatric

XXX

-

XXX

µg/dL

Test repeats

1

Panic

XXX

-

XXX

µg/dL

Controls


50

Calibrator name

XXX

-

500

µg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

µg/dL

Measurement

Name

COPPER

Predilution

No

0

Slope Blank

No

Incubation time

4.5

0 min

0 0

Sample Sample blank

No

0

normal volume


12.0

µL

rerun volume*

Factor

6.0

Absorbance limits

µl



3 rerun volume*

Absorbance

0.040

-

0.200

Abs

R. Absorbance

0.040

-

1.000

Abs

256

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

xxx

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-CUIVmono-1 47/123

CREATININE JAFFE ONE-REAGENT PROCEDURE Ref :

CRCO-0600 CRCO-0700

2 x 125 mL 4 x 250 mL



APPLICATION General

Sample types

Name

CREATININE JAFFE

Normal

Abbreviated name

CRCO

Allowed

Yes

Predilution

No

Code


Mode

Kinetic

Wavelength

505

0

Reference values nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

3

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


0.5

Calibrator name

XXX

-

15

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

CREATININE JAFFE

Predilution

No

Slope Blank

No

Delay, min. time

24

Alinearity

10

rerun volume*

Factor

1.00

15.0

Absorbance limits

0

0 0 106

0 sec

Sample Sample blank

No normal volume


25.0

µL

µl



3 rerun volume* µL

260

Absorbance

0.020

-

1.000

Abs

R. Absorbance

0.020

-

0.100

Abs

R. Abs. deviation

3.000

Abs

µl


0

0

µL

0

µl


µL

0

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

1

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-CRCOmono-1 48/123

CREATININE JAFFE ONE-REAGENT PROCEDURE Ref :

CRCO-0600 CRCO-0700

2 x 125 mL 4 x 250 mL



APPLICATION 0

0

FAUX

PERFORMANCE DATA Analyti cal range The reagent is linear from 0.5 to 15 mg/dL.



N 20 20 20


Mean (mg/dL) 0.668 1.477 5.698


CV% 2.5% 1.5% 1.6%


N 20 20 20

Mean (mg/dL) 0.679 1.494 5.703

CV% 3.1% 2.6% 3.0%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and MIRA on 30 human sera samples. The sample concentrations were between 0.47 and 18.26 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9996 Linear regression : y= 0.9590 x + 0.064 mg/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :Negative bias from 2.9 mg/dL. Conjugated bilirubin :Negative bias from 2.3 mg/dL. Haemoglobin: Negative bias from 150 mg/dL. Turbidity :No significant interference up to 580 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert).

On board stability (refrigerated position) The working reagent is stable 24 hours on analyser without recalibrating.

 Modification


(05/2009) AA-PROXS/EL80-CRCOmono-1 49/123

CREATININE JAFFE TWO-REAGENT PROCEDURE Ref :

CRCO-0600 CRCO-0700

2 x 125 mL 4 x 250 mL



APPLICATION General

Sample types

Name

CREATININE JAFFE

Normal

Abbreviated name

CRCO

Allowed

Yes

Predilution

No

Code


Mode

Kinetic

Wavelength

505

0

Reference values nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

3

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


0.5

Calibrator name

XXX

-

15

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

CREATININE JAFFE

Predilution

No

Slope Blank

No

Delay, min. time

24

Alinearity

10

rerun volume*

Factor

1.00

15.0

Absorbance limits

0

0 0 106

0 sec

Sample Sample blank

No normal volume


25.0

µL

µl



3 rerun volume* µL

130

Absorbance

0.020

-

1.000

Abs

R. Absorbance

-0.010

-

0.010

Abs

Substrate depletion

3.000

Abs

µl


0

0

µL

0

µl


µL

130

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

4

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-CRCObi-1 50/123

CREATININE JAFFE TWO-REAGENT PROCEDURE Ref :

CRCO-0600 CRCO-0700

2 x 125 mL 4 x 250 mL



APPLICATION 0

0

FAUX

PREPARATION OF REAGENTS: Position R1: Reagent 1 Position R3: Reagent 2




N 20 20 20


Mean (mg/dL) 0.709 1.539 5.839


CV% 2.4% 1.1% 1.6%


N 20 20 20

Mean (mg/dL) 0.688 1.517 5.761

CV% 3.1% 2.4% 1.9%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and MIRA on 30 human sera samples. The sample concentrations were between 0.47 and 18.26 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9998 Linear regression : y= 0.9604 x + 0.052 mg/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :Negative bias from 2.9 mg/dL. Conjugated bilirubin :Negative bias from 2.3 mg/dL. Haemoglobin: Negative bias from 150 mg/dL. Turbidity :No significant interference up to 580 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert).

On board stability (refrigerated position) The reagents are stable 4 days on analyser without recalibrating.

 Modification


(05/2009) AA-PROXS/EL80-CRCObi-1 51/123

CREATININE PAP SL TWO-REAGENT PROCEDURE Ref :

CRSL-0250 CRSL-0455 CRSL-0630

8 x 28 mL 4 x 60 mL 2 x 133 mL



APPLICATION General


Sample types

Name

CREATININE PAP SL

Normal

Abbreviated name

CRSL

Allowed

Yes

Code

420

Predilution

No

Mode

Kinetic

Wavelength

546

0

Reference values nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

3

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


0.3

Calibrator name

XXX

-

30

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

CREATININE PAP SL

Slope Blank

No

Predilution

No

Delay, min. time

50

Alinearity

15

rerun volume*

Factor

1.00

8.0

Absorbance limits

0

0 0 133

0 sec

Sample Sample blank

No normal volume


8.0

µL

µl



3 rerun volume* µL

210

µl

µL

0

µl

µL

70

µl

Absorbance

-0.050

-

1.500

Abs

R. Absorbance

-0.050

- 0.010

Abs

Substrate depletion

0.100


Reagent addition at 4.70 minutes (R3) 70 Calibrator

0

9.000

0

9.000

0

9.000

XXX

Number of standards

1


-

Repeats

3

Interval

14

Auto predilution

0

0 9.000

0

0

No

0 0

0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0 9.000

Predilution

Name


Abs

0

0


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-CRSLbi-1 52/123

CREATININE PAP SL TWO-REAGENT PROCEDURE Ref :

CRSL-0250 CRSL-0455 CRSL-0630

8 x 28 mL 4 x 60 mL 2 x 133 mL



APPLICATION 0

0

FAUX

PERFORMANCES DATA Analytic al ran ge The reagent is linear from 0.3 to 30 mg/dL.



N 20 20 20


Mean (mg/dL) 0.567 1.530 6.874


CV% 1.5% 1.0% 0.8%


N 20 20 20

Mean (mg/dL) 0.557 1.526 6.935

CV% 3.2% 2.2% 2.1%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific XL on 30 human sera samples. The sample concentrations were between 0.27 and 34.2 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9998 Linear regression : y= 1.0034 x + 0.048 mg/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :No significant interference up to 29 mg/dL. Conjugated bilirubin :Negative bias from 14 mg/dL. Haemoglobin: No significant interference up to 500 mg/dL. Turbidity :No significant interference up to 600 mg/dL Triglycerides equivalent. Uric acid: No significant interference up to 20 mg/dL. Calcium dobesilate: Negative bias from 0.85 mg/dL. Creatine: No significant interference up to 10 mg/dL. Methyldopa: Negative bias from 0.20 mg/dL. Glucose: No significant interference up to 500 mg/dL. Ascorbic acid: No significant interference up to 20 mg/dL. Other compounds may interfere (see product insert).


 Modification


(05/2009) AA-PROXS/EL80-CRSLbi-1 53/123

GAMMA GT SL ONE-REAGENT PROCEDURE Ref :

GASL-0400 GASL-0420 GASL-0500

2 x 62.5 mL 4 x 62.5 mL 5 x 125 mL



APPLICATION General

Sample types

Name

GAMMA GT SL

Normal

Abbreviatedname

GASL

Allowed

Yes

Predilution

No

Code


Mode

Kinetic

Wavelength

405

Units

U/L

0

Reference values nm

0

Male

XXX

-

XXX

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls

-

1000

U/L

Control 1

XXX


15

Control 2

XXX

Calibrator name

XXX

Control 3

XXX

Prozone check

No

Correlation factor

1.000

Correlation offset

0.000

Correlation

General

U/L

Measurement

Name

GAMMA GT SL

Predilution

No

Slope Blank

No

Delay, min. time

50

Alinearity

20

rerun volume*

Factor

1.00

15.0

Absorbance limits

0

0 0 159

0 sec

Sample Sample blank

No normal volume


25.0

µL

µl



3 rerun volume* µL

260

Absorbance

0.300

-

3.000

Abs

R. Absorbance

0.300

-

1.500

Abs

R. Abs. deviation

3.000

Abs

µl


0

0

µL

0

µl


µL

0

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1


-

Repeats

3

Interval

21

Auto predilution

No

0 0

0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-GASLmono-1 54/123

GAMMA GT SL ONE-REAGENT PROCEDURE Ref :

GASL-0400 GASL-0420 GASL-0500

2 x 62.5 mL 4 x 62.5 mL 5 x 125 mL


APPLICATION


0

0

FAUX




N 20 20 20



Mean (U/L) 20 50 308

CV% 1.0% 0.4% 0.6%


N 20 20 20

Mean (U/L) 20 49 375

CV% 2.2% 1.6% 1.2%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific XL on 30 human sera samples. The sample concentrations were between 11 and 906 U/L. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9999 Linear regression : y= 1.0155 x - 3 U/L

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :Positive bias from 23 mg/dL on normal human sera. No significant interference up to 35 mg/dL on pathological human sera. Conjugated bilirubin :No significant interference up to 25 mg/dL. Hemoglobin: No significant interference up to 500 mg/dL. Turbidity :No significant interference up to 600 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert).


 Modification


(05/2009) AA-PROXS/EL80-GASLmono-1 55/123

GAMMA GT SL TWO-REAGENT PROCEDURE Ref :

GASL-0250 GASL-0400 GASL-0420 GASL-0500



APPLICATION General


8 x 25 mL 2 x 62.5 mL 4 x 62.5 mL 5 x 125 mL

Sample types

Name

GAMMA GT SL

Normal

Abbreviatedname

GASL

Allowed

Yes

Code

440

Predilution

No

Mode

Kinetic

Wavelength

405

Units

U/L

0

Reference values nm

0

Male

XXX

-

XXX

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls

-

1000

U/L

Control 1

XXX


15

Control 2

XXX

Calibrator name

XXX

Control 3

XXX

Prozone check

No

Correlation factor

1.000

Correlation offset

0.000

Correlation

General

U/L

Measurement

Name

GAMMA GT SL

Predilution

No

Slope Blank

No

Delay, min. time

50

Alinearity

20

rerun volume*

Factor

1.00

14.0

Absorbance limits

0

0 0 159

0 sec

Sample Sample blank

No normal volume


24.0

µL

µl



3 rerun volume* µL

250

Absorbance

-0.100

-

3.000

Abs

R. Absorbance

-0.100

-

1.000

Abs

Substrate depletion

3.000

0

0

µL

0

µl


µL

60

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1


-

Repeats

3

Interval

28

Auto predilution

No

0 0

0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


Abs

µl



%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-GASLbi-1 56/123

GAMMA GT SL TWO-REAGENT PROCEDURE Ref :


APPLICATION

GASL-0250 GASL-0400 GASL-0420 GASL-0500

8 x 25 mL 2 x 62.5 mL 4 x 62.5 mL 5 x 125 mL


0

0

FAUX




N 20 20 20



Mean (U/L) 21 50 392

CV% 2.6% 0.7% 0.4%


N 20 20 20

Mean (U/L) 22 55 387

CV% 2.9% 2.0% 1.1%


Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :Positive bias from 24 mg/dL on normal human sera. No significant interference up to 35 mg/dL on pathological human sera. Conjugated bilirubin :No significant interference up to 25 mg/dL. Hemoglobin: No significant interference up to 500 mg/dL. Turbidity :No significant interference up to 600 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert).


 Modification


(05/2009) AA-PROXS/EL80-GASLbi-1 57/123

GAMMA GT Ref :

GAGT-0030 GAGT-0200

20 x 3 mL 12 x 20 mL



APPLICATION General

Sample types

Name

GAMMA GT

Normal

Abbreviated name

GAGT

Allowed

Yes

Predilution

No

Code


PROPOSAL

Mode

Kinetic

Wavelength

405

Units

0

Reference values nm

0

Male

XXX

-

XXX

U/L

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls


10

Calibrator name

XXX

-

300

U/L

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

U/L

Measurement

Name

GAMMA GT

Predilution

No

0

Slope Blank

No

Delay, min. time

50

Alinearity

20

Factor

1.00

0 0 159

0 sec

Sample Sample blank

No normal volume


25.0

rerun volume* µL

15.0

µl



3 rerun volume* µL

260


0.000

-

3.000

Abs

R. Absorbance

0.000

-

3.000

Abs

R. Abs. deviation

3.000

Abs

µl


0

0

µL

0

µl

µL

0

µl


Calibrator


0

9.000

0

9.000

0

9.000

XXX

Number of standards

1


-

Repeats

3

Interval

xxx

Auto predilution

0

0 9.000

0

0

No

0 0

0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0 9.000

Predilution

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-GAGT-1 58/123

GLUCOSE HK SL ONE REAGENT PROCEDURE Ref :

GHSL-0600

5 x 125 mL



APPLICATION General

Sample types

Name

GLUCOSE HK SL

Normal

Abbreviated name

GHSL

Allowed

Yes

Predilution

No

Code


Mode


Wavelength

340

0

Reference values

nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


20

Calibrator name

XXX

-

600

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

GLUCOSE HK SL

Predilution

No

0

Slope Blank

No

Incubation time

4.5

0 min

0 0

Sample Sample blank

No

0

normal volume


3.0

µL

rerun volume*

Factor

2.0

Absorbance limits

µl



3 rerun volume*

Absorbance

0.000

-

3.000

Abs

R. Absorbance

0.000

-

0.750

Abs

301

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

28

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-GHSLmono-1 59/123

GLUCOSE HK SL ONE REAGENT PROCEDURE Ref :

GHSL-0600

5 x 125 mL



APPLICATION 0

0

FAUX


Detection limi t Determined according to SFBC protocol, the detection limit is equal to 1 mg/dL.


N 20 20 20


Mean (mg/dL) 37 98 286


CV% 1.0% 0.7% 0.8%


N 20 20 20

Mean (mg/dL) 38 96 280

CV% 1.8% 1.7% 1.5%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific XL on 30 human sera samples. The sample concentrations were between 17 and 593 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :1.0000 Linear regression : y= 1.0003 x - 0.57 mg/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :No significant interference up to 35 mg/dL. Conjugated bilirubin :No significant interference up to 20 mg/dL. Haemoglobin: Positive bias from 200 mg/dL on normal human serum and from 400 mg/dL on pathological human serum. Turbidity : Positive bias from 300 mg/dL Triglycerides equivalent on normal human serum and from 430 mg/dL Triglycerides equivalent on pathological human serum. Ascorbic acid: No significatnt inteference up to 40 mg/dL. Other compounds may interfere (see product insert).


 Modification


(05/2009) AA-PROXS/EL80-GHSLmono-1 60/123

GLUCOSE HK SL TWO REAGENT PROCEDURE Ref :

GHSL-0250 GHSL-0600

8 x 25 mL 5 x 125 mL



APPLICATION General


Sample types

Name

GLUCOSE HK SL

Normal

Abbreviated name

GHSL

Allowed

Yes

Code

460

Predilution

No

Mode


Reference values

Wavelength

340

nm

0

Male

0

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


20

Calibrator name

XXX

-

750

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

GLUCOSE HK SL

Predilution

No

0

Slope Blank

No

Incubation time

6.5

0 min

0 0

Sample Sample blank

No

0

normal volume


3.0

µL

rerun volume*

Factor

2.0

Absorbance limits

µl



3 rerun volume*

Absorbance

0.150

-

3.000

Abs

R. Absorbance

0.000

-

0.300

Abs

281

9.000

0

0

µL

0

µl


µL

70

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

28

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-GHSLbi-1 61/123

GLUCOSE HK SL TWO REAGENT PROCEDURE Ref :

GHSL-0250 GHSL-0600

8 x 25 mL 5 x 125 mL



APPLICATION 0

0

FAUX




N 20 20 20


Mean (mg/dL) 36 94 316


CV% 2.0% 1.6% 0.6%


N 20 20 20

Mean (mg/dL) 36 93 302

CV% 1.4% 1.6% 0.9%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific E on 31 human sera samples. The sample concentrations were between 11 and 736 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9999 Linear regression : y= 1.0182 x + 2.1 mg/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :No significant interference up to 36 mg/dL. Conjugated bilirubin :No significant interference up to 25 mg/dL. Haemoglobin: Positive bias from 500 mg/dL. Turbidity :No significant interference up to 614 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert).


 Modification


(05/2009) AA-PROXS/EL80-GHSLbi-1 62/123

GLUCOSE PAP SL Ref :


12 x 20 mL 6 x 45 mL 1 x 100 mL 6 x 100 mL 6 x 100 mL +STD 4 x 250 mL 4 x 250 mL +STD


APPLICATION General


GPSL-0250 GPSL-0455 GPSL-0490 GPSL-0500 GPSL-0507 GPSL-0700 GPSL-0707

Sample types

Name

GLUCOSE PAP SL

Normal

Abbreviatedname

GPSL

Allowed

Yes

Code

480

Predilution

No

Mode


Wavelength

505

Units

mg/dL

0

Reference values

nm

0

Male

XXX

-

XXX

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls

-

400

mg/dL

Control 1

XXX


20

Control 2

XXX

Calibrator name

XXX

Control 3

XXX

Prozone check

No

Correlation factor

1.000

Correlation offset

0.000

Correlation

General

mg/dL

Measurement

Name

GLUCOSE PAP SL

Predilution

No

0

Slope Blank

No

Incubation time

11.5

0 min

0 0

Sample Sample blank

No

0

normal volume


3.0

µL

rerun volume*

Factor

2.0

Absorbance limits

µl



3 rerun volume*

Absorbance

-0.100

-

3.000

Abs

R. Absorbance

-0.100

-

0.200

Abs

398

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1


-

Repeats

3

Interval

28

Auto predilution

No

0 0

0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-GPSL-1 63/123

GLUCOSE PAP SL Ref :

GPSL-0250 GPSL-0455 GPSL-0490 GPSL-0500 GPSL-0507 GPSL-0700 GPSL-0707


12 x 20 mL 6 x 45 mL 1 x 100 mL 6 x 100 mL 6 x 100 mL +STD 4 x 250 mL 4 x 250 mL +STD


APPLICATION 0

0

FAUX




N 20 20 20


Mean (mg/dL) 36 94 313


CV% 1.6% 1.7% 0.6%


N 20 20 20

Mean (mg/dL) 36 93 306

CV% 1.3% 1.7% 1.4%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific E on 31 human sera samples. The sample concentrations were between 15 and 398 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9995 Linear regression : y= 1.0243 x + 0.97 mg/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :No significant interference up to 35 mg/dL. Conjugated bilirubin :No significant interference up to 25 mg/dL on pathological human serum. Negative bias from 15 mg/dL on normal human sera. Haemoglobin: No significant interference up to 500 mg/dL. Turbidity : Positive bias from 440 mg/dL Triglycerides equivalent on normal human serum and no significant interference up to 600 mg/dL Triglycerides equivalent on pathological human serum. Ascorbic acid: Negative bias from 10 mg/dL on normal human serum and from 16 mg/dL on pathological human serum. Uric acid: No significant interference up to 22 mg/dL. Other compounds may interfere (see product insert).


 Modification


(05/2009) AA-PROXS/EL80-GPSL-1 64/123

GLUCOSE PAP Ref :

GLUP-0700 GLUP-0800

4 x 250 mL 5 x 500 mL



APPLICATION General

Sample types

Name

GLUCOSE PAP

Normal

Abbreviated name

GLUP

Allowed

Yes

Predilution

No

Code


PROPOSAL

Mode


Wavelength

505

0

Reference values

nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


50

Calibrator name

XXX

-

400

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

GLUCOSE PAP

Predilution

No

0

Slope Blank

No

Incubation time

11.5

0 min

0 0

Sample Sample blank

No

0

normal volume


3.0

µL

rerun volume*

Factor

2.0

Absorbance limits

µl



3 rerun volume*

Absorbance

-0.100

-

3.000

Abs

R. Absorbance

-0.100

-

0.200

Abs

301

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

xxx

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-GLUP-1 65/123

IRON FERROZINE Ref :

FEFR-0250 FEFR-0600

10 x 20 mL 2 x 125 mL



APPLICATION General


Sample types

Name

IRON

Normal

Abbreviated name

FEFR

Allowed

Yes

Code

500

Predilution

No

Mode


Reference values

Wavelength

546

Male

XXX

-

XXX

µg/dL

Units

µg/dL

Female

XXX

-

XXX

µg/dL

Decimals

0

Pediatric

XXX

-

XXX

µg/dL

Test repeats

1

Panic

XXX

-

XXX

µg/dL

nm

0

0

Controls


15

Calibrator name

XXX

-

900

µg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

µg/dL

Measurement

Name

IRON

Predilution

No

0

Slope Blank

No

Incubation time

6.5

0 min

0 0

Sample Sample blank

No

0

normal volume


30.0

rerun volume* µL

20.0

µl



3 rerun volume*


-0.100

-

1.000

Abs

R. Absorbance

-0.100

-

0.100

Abs

0 µL

230

µl

µL

0

µl


9.000


µL

11

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Auto predilution

Number of standard

1

0


-

0

Repeats

3

Interval

14

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


0

0

0


0 1.00

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-FEFR-1 66/123

IRON FERROZINE Ref :

FEFR-0250 FEFR-0600

10 x 20 mL 2 x 125 mL



APPLICATION 0

0

FAUX

PERFORMANCE DATA Analytical range The reagent is linear from 15 to 900 µg/dL.

Detection limit Determined according to SFBC protocol, the detection limit is equal to 3 µg/dL.


N 20 20 20


Mean (µg/dL) 29 116 234


CV% 3.5% 1.1% 1.3%


N 20 20 20

Mean (µg/dL) 31 124 247

CV% 3.8% 3.0% 2.6%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific XL on 30 human sera samples. The sample concentrations were between 13 and 1030 µg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :1.000 Linear regression : y= 0.9921 x + 1.6 µg/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :No significant interference up to 36 mg/dL. Conjugated bilirubin :No significant interference up to 25 mg/dL. Turbidity :Positive bias 400 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert). Note: Hemolysed sera should not be used since significant hemolysis increases iron concentration due to high level of iron in erythrocytes.


 Modification


(05/2009) AA-PROXS/EL80-FEFR-1 67/123

LACTATE Ref :

LACT-0100

10 x 10 mL



APPLICATION General

Sample types

Name

LACTATE

Normal

Abbreviated name

LACT

Allowed

Yes

Predilution

No

Code


PROPOSAL

Mode


Wavelength

546

0

Reference values

nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

1

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


2

Calibrator name

XXX

-

120

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

LACTATE

Predilution

No

0

Slope Blank

No

Incubation time

4.5

0 min

0 0

Sample Sample blank

No

0

normal volume


3.0

µL

rerun volume*

Factor

2.0

Absorbance limits

µl



3 rerun volume*

Absorbance

0.000

-

2.000

Abs

R. Absorbance

0.000

-

0.500

Abs

301

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

xxx

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-LACT-1 68/123

LDH-L SL TWO-REAGENT PROCEDURE Ref :

LLSL-0400 LLSL-0420

2 x 62.5 mL 4 x 62.5 mL



APPLICATION General

Sample types

Name

LDH-L SL

Normal

Abbreviated name

LLSL

Allowed

Yes

Predilution

No

Code


PROPOSAL

Mode

Kinetic

Wavelength

340

0

Reference values nm

0

Male

XXX

-

XXX

U/L

Units

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls


50

Calibrator name

XXX

-

1200

U/L

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

U/L

Measurement

Name

LDH-L SL

Predilution

No

Slope Blank

No

Delay, min. time

77

Alinearity

10

rerun volume*

Factor

1.00

3.0

Absorbance limits

0

0 0 159

0 sec

Sample Sample blank

No normal volume


7.0

µL

µl



3 rerun volume* µL

204

Absorbance

0.300

-

1.600

Abs

R. Absorbance

-0.010

-

0.010

Abs

Substrate depletion

3.000

Abs

µl


0

0

µL

0

µl


µL

50

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

xxx

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-LLSLbi-1 69/123

LDH-P 4+1 SL ONE-REAGENT PROCEDURE PROCEDURE Ref :

LDSL-0410 LDSL-0430

2 x 62.5 mL 4 x 62 62.5mL



APPLICATION Gen er al

Sam p l e t yp es

Name

LDH-P 4+1 SL

Normal

Abb Abbrevi reviat ated edname

LDSL

Allow lowed

Yes

Predilution

No

Code


Mode

Kinetic

Wavelength

340

Units

U/L

0

Reference values nm

0

Male

XXX

-

XXX

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls

-

1500

U/L

Control 1

XXX


50

Control 2

XXX

Calibrator name

XXX

Control 3

XXX

Prozone check

No

Correlation factor

1.000

Correlation offset

0.000

Correlation

Gen er al

U/L

Meas u r em en t

Name

LDH-P 4+1 SL

Predilution

No

Slope Blank

No

Delay, min. time

24

Alinearity

20

rerun volume*

Factor

1.00

2.0

Absorbance limits

0

0 0 106

0 sec

Sample Sample blank

No normal volume


4.0

µL

µl



3 rerun volume* µL

302

Abs Absorb orbance

0.00 0.000

-

1.60 1.600

Abs

R. Absorbance

1.000

-

1. 1.600

Abs

R. Abs. deviation

0.100

Abs

µl


0

0

µL

0

µl


µL

0

µl

Cal i b r at o r


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1


-

Repeats

3

Interval

7

Auto predilution

No

0 0

0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0

Aut Auto o accept calibra libratio tion Concentration xxx

Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Pr ed i l u t i o n

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA AA-PR -PROXS/EL /EL80-LD -LDSL4+1mono-1 70/123

LDH-P 4+1 SL ONE-REAGENT PROCEDURE PROCEDURE Ref :

LDSL-0410 LDSL-0430

2 x 62.5 mL 4 x 62 62.5mL


APPLICATION


0

0

FAUX

PERFORMANCE DATA Analy An alytitical cal range ran ge The reagent is linear from 50 to 1500 U/L.


Precision Wi t hi n r un reproduci bi l i t y

N 20 20 20


Bet ween run repr oduci bi l i t y

Mean (U/L) 149 311 935

CV% 1.7% 0.9% 0.6%


N 20 20 20

Mean (U/L) 147 310 644

CV% 4.7% 3.4% 3.9%

Correlation A comparati rativ ve stud tudy has been perfo rformed between Selec lectra tra ProX roXS / Flex lexor EL80 and Vita ital Scien ientifi tific c XL on 31 human sera samples les. The sample concentrations were between 58 and 1453 U/L. The parameters of linear regression are as follows : Correlation Correlation coefficient (r) :0.9990 Linear regression : y= 0.9136 x + 2.5 U/L

Interferences Ac Accordin rding g to SFBC rec recommendatio tions some stud tudies ies have been perfo rformed to determ termine ine the the lev level of inte interf rfe eren rence from different compounds: Unconjugated bilirubin :Negative bias from 12 mg/dL. Conjugated bilirubin :Negative bias from 8.8 mg/dL. Turbidity :No significant interference up to 600 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert). Note:

Hemolysed sera should not be used since significant haemolysis may increase LDH concentrations because of high levels of LDH in erythrocytes.

On board stability (refrigerated position) The working reagent is stable 1 week on analyser without recalibrating.

 Modification


(05/2009) AA AA-PR -PROXS/EL /EL80-LD -LDSL4+1mono-1 71/123

LDH-P 4+1 SL TWOTWO-REAGENT PROCEDURE Ref :

LDSL-0230 LDSL-0410 LDSL-0430

4 x 25 mL 2 x 62 62.5mL 4 x 62 62.5mL





Sam p l e t yp es

Name

LDH-P 4+1 SL

Normal

Abb Abbrevi reviat ated edname

LDSL

Allow lowed

Yes

Code

520

Predilution

No

Mode

Kinetic

Wavelength

340

Units

U/L

0

Reference values nm

0

Male

XXX

-

XXX

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls

-

1500

U/L

Control 1

XXX


50

Control 2

XXX

Calibrator name

XXX

Control 3

XXX

Prozone check

No

Correlation factor

1.000

Correlation offset

0.000

Correlation

Gen er al

U/L

Meas u r em en t

Name

LDH-P 4+1 SL

Predilution

No

Slope Blank

No

Delay, min. time

24

Alinearity

20

rerun volume*

Factor

1.00

2.5

Absorbance limits

0

0 0 106

0 sec

Sample Sample blank

No normal volume


4.5

µL

µl



3 rerun volume* µL

262

Abs Absorb orbance

0.00 0.000

-

1.70 1.700

Abs

R. Absorbance

-0.100

-

1. 1.000

Abs

Substrate depletion

-0.400

0

0

µL

0

µl


µL

65

µl

Cal i b r at o r

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1


-

Repeats

3

Interval

28

Auto predilution

No

0 0

0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0

Aut Auto o accept calibra libratio tion Concentration xxx

Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Pr ed i l u t i o n

Name


Abs

µl



%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA AA-PR -PROXS/EL /EL80-LD -LDSL4+1bi-1 i-1 72/123

LDH-P 4+1 SL TWO-REAGENT PROCEDURE Ref :

LDSL-0230 LDSL-0410 LDSL-0430

4 x 25 mL 2 x 62.5mL 4 x 62.5mL


APPLICATION


0

0

FAUX




N 20 20 20



Mean (U/L) 151 315 661

CV% 2.1% 1.4% 1.1%


N 20 20 20

Mean (U/L) 150 310 653

CV% 4.8% 2.5% 2.6%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific XL on 31 human sera samples. The sample concentrations were between 53 and 1437 U/L. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9998 Linear regression : y= 0.9808 x + 1.1 U/L

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :Negative bias from 12 mg/dL. Conjugated bilirubin :Negative bias from 8.8 mg/dL. Turbidity :No significant interference up to 600 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert). Note:

Hemolysed sera should not be used since significant haemolysis may increase LDH concentrations because of high levels of LDH in erythrocytes.


 Modification


(05/2009) AA-PROXS/EL80-LDSL4+1bi-1 73/123

LDH-P Ref :

LDHP-0030

20 x 3 mL



APPLICATION General

Sample types

Name

LDH-P

Normal

Abbreviated name

LDH

Allowed

Yes

Predilution

No

Code


PROPOSAL

Mode

Kinetic

Wavelength

340

0

Reference values nm

0

Male

XXX

-

XXX

U/L

Units

U/L

Female

XXX

-

XXX

U/L

Decimals

0

Pediatric

XXX

-

XXX

U/L

Test repeats

1

Panic

XXX

-

XXX

U/L

Controls


60

Calibrator name

XXX

-

1500

U/L

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

U/L

Measurement

Name

LDH-P

Predilution

No

Slope Blank

No

Delay, min. time

50

Alinearity

10

rerun volume*

Factor

1.00

3.0

Absorbance limits

0

0 0 133

0 sec

Sample Sample blank

No normal volume


5.0

µL

µl



3 rerun volume* µL

252

Absorbance

0.050

-

1.700

Abs

R. Absorbance

0.900

-

1.700

Abs

R. Abs. deviation

0.100

Abs

µl


0

0

µL

0

µl


µL

0

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

xxx

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-LDHP-1 74/123

MAGNESIUM CALMAGITE ONE-REAGENT PROCEDURE Ref :

MAGN-0600

2 x 125 mL



APPLICATION General

Sample types

Name

MAGNESIUM CALMAGITE

Normal

Abbreviated name

MAGN

Allowed

Yes

Predilution

No

Code


Mode


Wavelength

546

0

Reference values

nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

2

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


0.7

Calibrator name

XXX

-

5.0

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

MAGNESIUM CALMAGITE

Slope Blank

No

Predilution

No

Incubation time

4.5

0

0 min

0 0

Sample Sample blank

No

0

normal volume


3.0

µL

rerun volume*

Factor

2.0

Absorbance limits

µl



3 rerun volume*

Absorbance

0.700

-

1.600

Abs

R. Absorbance

0.700

-

1.300

Abs

301

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

Auto predilution

3

Interval

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-MAGNmono-1 75/123

MAGNESIUM CALMAGITE ONE-REAGENT PROCEDURE Ref :

MAGN-0600

2 x 125 mL



APPLICATION 0

0

FAUX

PERFORMANCE DATA Analyti cal range The reagent is linear from 0.7 to 5.0 mg/dL.



N 20 20 20


Mean (mg/dL) 1.12 2.21 4.23


CV% 1.3% 2.3% 0.7%


N 20 20 20

Mean (mg/dL) 1.14 2.28 4.24

CV% 3.3% 2.8% 3.0%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific E on 30 human sera samples. The sample concentrations were between 0.28 and 6.45 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9986 Linear regression : y= 1.0416 x - 0.05 mg/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :Positive bias from 15 mg/dL. Conjugated bilirubin :Positive bias from 10 mg/dL. Turbidity :Positive bias from 263 mg/dL Triglycerides equivalent. Calcium: No significant interference up to 28.5 mg/dL. Other compounds may interfere (see product insert). Note: Do not use hemolysed samples.

On board stability (refrigerated position) The working reagent is stable 8 hours on analyser without recalibrating.

Modification


(05/2009) AA-PROXS/EL80-MAGNmono-1 76/123

MAGNESIUM CALMAGITE TWO-REAGENT PROCEDURE Ref :

MAGN-0125 MAGN-0600

8 x 12 mL 2 x 125 mL



APPLICATION General


Sample types

Name

MAGNESIUM CALMAGITE

Normal

Abbreviated name

MAGN

Allowed

Yes

Code

540

Predilution

No

Mode

Two point

Reference values

Wavelength

546

nm

0

Male

0

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

2

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


0.7

Calibrator name

XXX

-

5.0

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

MAGNESIUM CALMAGITE

Slope Blank

No

Predilution

No

Point one, two

-3

0

0 0 236

0 sec

Sample Sample blank

No

0

normal volume


6.0

µL

rerun volume*

Factor

3.0

Absorbance limits

µl



3 rerun volume* µL

233

1.00

Absorbance

-0.010

-

1.500

Abs

R. Absorbance

-0.010

-

0.010

Abs

Substrate depletion

0.000

Abs

µl


0

0

µL

0

µl


µL

164

µl

Calibrator


0

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

Predilution

Name

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

2

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Concentration xxx

Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


Modification

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-MAGNbi-1 77/123

MAGNESIUM CALMAGITE TWO-REAGENT PROCEDURE Ref :

MAGN-0125 MAGN-0600

8 x 12 mL 2 x 125 mL



APPLICATION 0

0

FAUX

PERFORMANCE DATA Analyti cal range The reagent is linear from 0.7 to 5.0 mg/dL.



N 20 19

Level 1 Level 2

Mean (mg/dL) 2.27 4.20


CV% 2.4% 1.4%

Level 1 Level 2

N 19 19

Mean (mg/dL) 2.30 4.29

CV% 3.5% 3.6%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific E on 30 human sera samples. The sample concentrations were between 0.28 and 6.45 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9982 Linear regression : y= 1.0060 x + 0.04 mg/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :No significant interference up to 36 mg/dL. Conjugated bilirubin :No significant interference up to 25 mg/dL. Turbidity :No significant interference up to 600 mg/dL Triglycerides equivalent. Calcium: Positive bias from 20 mg/dL. Other compounds may interfere (see product insert). Note: Do not use hemolysed samples.

On board stability (refrigerated position) The reagents are stable 2 days on analyser without recalibrating.

Modification


(05/2009) AA-PROXS/EL80-MAGNbi-1 78/123

MICROPROTEIN Ref :

PRTP-0250 PRTP-0600

12 x 20 mL 2 x 125 mL



APPLICATION General


Sample types

Name

MICROPROTEIN

Normal

Abbreviated name

PRTP

Allowed

Yes

Code

580

Predilution

No

Mode


Reference values

Wavelength

620

nm

0

Male

0

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

1

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


12.5

Calibrator name

XXX

-

200

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

MICROPROTEIN

Predilution

No

0

Slope Blank

No

Incubation time

4.5

0 min

0 0

Sample Sample blank

No

0

normal volume


5.0

µL

rerun volume*

Factor

3.0

Absorbance limits

µl



3 rerun volume*

Absorbance

0.080

-

1.000

Abs

R. Absorbance

0.080

-

0.300

Abs

252

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

0

Predilution

Name

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

28

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0

Auto accept calibration N° Used

Concentration

#1 Standard #1

xxx

Yes Abs 0.000

0

FAUX

0 0 0 0 0

0 0 0 0 0



0

0

9.000

9.000

0

9.000

9.000

Absorbancelimite Abs** faible haute 0.270 0.400

0

 Modification

0

µl



1.00

0 µL

0

XXX: Enter data by the user * : For information only **: Defined for a concentration of 100 mg/dL. These data must be modified for other concentration.

(05/2009) AA-PROXS/EL80-PRTP-1 79/123

MICROPROTEIN Ref :

PRTP-0250 PRTP-0600

12 x 20 mL 2 x 125 mL



APPLICATION 0

0

FAUX




N 20 20 20


Mean (mg/dL) 19 63 119


CV% 1.2% 1.1% 0.7%


N 20 20 20

Mean (mg/dL) 19 64 120

CV% 1.9% 1.8% 1.9%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific E on 30 human urine samples. The sample concentrations were between 2.9 and 226 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9970 Linear regression : y= 1.0125 x - 0.37 mg/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Creatinine: No significant interference up to 500 mg/dL. Urea: No significant interference up to 5 g/dL. Glucose: No significant interference up to 2000 mg/dL. Other compounds may interfere (see product insert). Note: Do not use sample containing blood since hemoglobin reacts with the reagent.


 Modification


(05/2009) AA-PROXS/EL80-PRTP-1 80/123

PHOSPHORUS Ref :

PHOS-0230 PHOS-0600

6 x 20 mL 2 x 125 mL



APPLICATION General


Sample types

Name

PHOSPHORUS

Normal

Abbreviated name

PHOS

Allowed

Yes

Code

560

Predilution

No

Mode


Reference values

Wavelength

340

nm

0

Male

0

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

2

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


2

Calibrator name

XXX

-

20

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

PHOSPHORUS

Predilution

No

0

Slope Blank

No

Incubation time

4.5

0 min

0 0

Sample Sample blank

No

0

normal volume


3.0

µL

rerun volume*

Factor

3.0

Absorbance limits

µl



3 rerun volume*

Absorbance

0.000

-

1.500

Abs

R. Absorbance

0.100

-

0.300

Abs

300

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

28

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-PHOS-1 81/123

PHOSPHORUS Ref :

PHOS-0230 PHOS-0600

6 x 20 mL 2 x 125 mL



APPLICATION 0

0

FAUX




N 20 20 20


Mean (mg/dL) 2.25 3.74 9.28


CV% 0.9% 1.7% 1.1%


N 20 20 19

Mean (mg/dL) 2.25 3.82 9.73

CV% 2.0% 3.0% 2.7%


Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :No significant interference up to 36 mg/dL. Conjugated bilirubin :Positive bias from 6 mg/dL on normal human serum and from12 mg/dL on pathological human serum. Haemoglobin: Positive bias from 200 mg/dL on normal human serum and from 400 mg/dL on pathological human serum. Turbidity :Positive bias 260 mg/dL Triglycerides equivalent. Ascorbic acid:No significant interference up to 40 mg/dL. Glucose: No significant interference up to 550 mg/dL. Other compounds may interfere (see product insert).


Modification


(05/2009) AA-PROXS/EL80-PHOS-1 82/123

TOTAL PROTEIN Ref :

PRTB-0250 PRTB-0600 PRTB-0700

12 x 20 mL 2 x 125 mL 4 x 250 mL



APPLICATION General


Sample types

Name

TOTAL PROTEIN

Normal

Abbreviated name

PRTB

Allowed

Yes

Code

600

Predilution

No

Mode


Reference values

Wavelength

546

nm

0

Male

0

XXX

-

XXX

g/dL

Units

g/dL

Female

XXX

-

XXX

g/dL

Decimals

2

Pediatric

XXX

-

XXX

g/dL

Test repeats

1

Panic

XXX

-

XXX

g/dL

Controls


0.1

Calibrator name

XXX

-

10

g/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

g/dL

Measurement

Name

TOTAL PROTEIN

Predilution

No

0

Slope Blank

No

Incubation time

11.5

0 min

0 0

Sample Sample blank

No

0

normal volume


3.0

µL

rerun volume*

Factor

2.0

Absorbance limits

µl



3 rerun volume*

Absorbance

0.000

-

0.500

Abs

R. Absorbance

0.000

-

0.050

Abs

301

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

2

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-PRTB-1 83/123

TOTAL PROTEIN Ref :

PRTB-0250 PRTB-0600 PRTB-0700

12 x 20 mL 2 x 125 mL 4 x 250 mL


APPLICATION


0

0

FAUX

PERFORMANCE DATA Analyti cal range The reagent is linear from 0.1 to 10 g/dL.

Detection limi t Determined according to SFBC protocol, the detection limit is equal to 0.03 g/dL.


N 20 20 20



Mean (g/dL) 3.88 6.56 9.20

CV% 0.6% 0.8% 0.5%


N 20 20 20

Mean (g/dL) 3.88 6.60 9.32

CV% 2.6% 2.3% 1.8%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific E on 30 human sera samples. The sample concentrations were between 0.11 and 9.74 g/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9990 Linear regression : y= 1.0203 x - 0.02 g/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :No significant interference up to 36 mg/dL. Conjugated bilirubin :No significant interference up to 25 mg/dL. Haemoglobin: Positive bias from 50 mg/dL. Turbidity :Positive bias 400 mg/dL Triglycerides equivalent on normal human sera and from 206 mg/dL on pathological human serum. Other compounds may interfere (see product insert).

On board stability (refrigerated position) The reagent is stable 2 days on analyser without recalibrating.

 Modification


(05/2009) AA-PROXS/EL80-PRTB-1 84/123

TRIGLYCERIDES MONO SL NEW Ref : Instruction for use :

12 x 20 mL 6 x 50 mL 6 x 45 mL 6 x 100 mL

TGML-0700 TGML-0427 TGML-0517 TGML-0707

4 x 250 mL 6 x 50 mL +STD 6 x 100 mL +STD 4 x 250 mL +STD


APPLICATION General



Sample types

Name

TRIGLYCERIDES

Normal

Abbreviated name

TGML

Allowed

Yes

Code

620

Predilution

No

Mode


Reference values

Wavelength

505

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

nm

0

0

Controls


30

Calibrator name

XXX

-

1000

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

TRIGLYCERIDES

Predilution

No

0

Slope Blank

No

Incubation time

11.5

0 min

0 0

Sample Sample blank

No

0

normal volume


3.0

rerun volume* µL

2.0

µl



3 rerun volume*


0.000

-

2.000

Abs

R. Absorbance

0.000

-

0.200

Abs

0 µL

398

µl

µL

0

µl


9.000


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Auto predilution

Number of standard

1

0


-

0

Repeats

3

Interval

14

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


0

0

0


0 1.00

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-TGMLN-1 85/123

TRIGLYCERIDES MONO SL NEW Ref : Instruction for use :



12 x 20 mL 6 x 50 mL 6 x 45 mL 6 x 100 mL

4 x 250 mL 6 x 50 mL +STD 6 x 100 mL +STD 4 x 250 mL +STD


APPLICATION 0

0

FAUX




N 20 20 20


Mean (mg/dL) 47 127 273


CV% 2.0% 1.5% 1.3%


N 20 20 20

Mean (mg/dL) 46 124 266

CV% 2.6% 3.2% 3.4%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific E on 31 human sera samples. The sample concentrations were between 26 and 1008 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9997 Linear regression : y= 1.0346 x - 2.6 mg/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :No significant interference up to 36 mg/dL on normal human sera. Negative bias from 22 mg/dL on pathological human sera. Conjugated bilirubin :Negative bias from 16 mg/dL. Haemoglobin: Positive bias from 200 mg/dL on normal human serum, but no significant interference up to 500 mg/dL on pathological human serum Other compounds may interfere (see product insert).

On board stability (refrigerated position) The reagent is stable 4 weeks on analyser with a new calibration every 2 weeks.

 Modification


(05/2009) AA-PROXS/EL80-TGMLN-1 86/123

TRIGLYCERIDES Ref :

TRIG-0200 TRIG-0400

12 x 20 mL 9 x 50 mL



APPLICATION General

Sample types

Name

TRIGLYCERIDES

Normal

Abbreviated name

TRIG

Allowed

Yes

Predilution

No

Code


PROPOSAL

Mode


Wavelength

546

0

Reference values

nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


20

Calibrator name

XXX

-

1000

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

TRIGLYCERIDES

Predilution

No

0

Slope Blank

No

Incubation time

4.5

0 min

0 0

Sample Sample blank

No

0

normal volume


3.0

µL

rerun volume*

Factor

2.0

Absorbance limits

µl



3 rerun volume*

Absorbance

-0.100

-

2.500

Abs

R. Absorbance

-0.100

-

0.200

Abs

301

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

xxx

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-TRIG-1 87/123

UREA UV SL ONE-REAGENT PROCEDURE Ref : URSL-0400 URSL-0420 URSL-0500 URSL-0407 URSL-0427 URSL-0507


62.5 mL 62.5 mL 125 mL 62.5 mL +STD 62.5 mL +STD 125 mL +STD


APPLICATION General

Sample types

Name

UREA UV SL

Normal

Abbreviatedname

URSL

Allowed

Yes

Predilution

No

Code


2x 4x 5x 2x 4x 5x

Mode

Kinetic

Wavelength

340

Units

mg/dL

0

Reference values nm

0

Male

XXX

-

XXX

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls

-

300

mg/dL

Control 1

XXX


10

Control 2

XXX

Calibrator name

XXX

Control 3

XXX

Prozone check

No

Correlation factor

1.000

Correlation offset

0.000

Correlation

General

mg/dL

Measurement

Name

UREA UV SL

Predilution

No

Slope Blank

No

Delay, min. time

24

Alinearity

20

rerun volume*

Factor

1.00

2.0

Absorbance limits

0

0 0 106

0 sec

Sample Sample blank

No normal volume


3.0

µL

µl



3 rerun volume* µL

301

Absorbance

0.500

-

2.000

Abs

R. Absorbance

1.200

-

2.000

Abs

R. Abs. deviation

0.200

Abs

µl


0

0

µL

0

µl

Reagent addition at 4.70 minutes (R3) µL

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1


-

Repeats

3

Interval

14

Auto predilution

No

0 0

0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-URSLmono-1 88/123

UREA UV SL ONE-REAGENT PROCEDURE Ref : URSL-0400 URSL-0420 URSL-0500 URSL-0407 URSL-0427 URSL-0507


2x 4x 5x 2x 4x 5x

62.5 mL 62.5 mL 125 mL 62.5 mL +STD 62.5 mL +STD 125 mL +STD


APPLICATION 0

0

FAUX

PERFORMANCES DATA Analytical range The reagent is linear from 10 to 300 mg/dL.



N 20 20 20


Mean (mg/dL) 14 59 149


CV% 0.0% 0.7% 0.8%


N 20 20 20

Mean (mg/dL) 14 60 149

CV% 4.7% 2.4% 0.6%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific E on 30 human sera samples. The sample concentrations were between 11 and 343 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9993 Linear regression : y= 0.9573 x + 2 mg/dL



 Modification


(05/2009) AA-PROXS/EL80-URSLmono-1 89/123

UREA UV SL TWO-REAGENT PROCEDURE Ref : Instruction for use :

8 x 25 mL 2 x 62.5 mL 4 x 62.5 mL 4 x 55 mL

URSL-0500 URSL-0407 URSL-0427 URSL-0507

5x 2x 4x 5x

125 mL 62.5 mL +STD 62.5 mL +STD 125 mL +STD


APPLICATION General



Sample types

Name

UREA UV SL

Normal

Abbreviatedname

URSL

Allowed

Yes

Code

640

Predilution

No

Mode

Kinetic

Wavelength

340

Units

mg/dL

0

Reference values nm

0

Male

XXX

-

XXX

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls

-

300

mg/dL

Control 1

XXX


10

Control 2

XXX

Calibrator name

XXX

Control 3

XXX

Prozone check

No

Correlation factor

1.000

Correlation offset

0.000

Correlation

General

mg/dL

Measurement

Name

UREA UV SL

Predilution

No

Slope Blank

No

Delay, min. time

24

Alinearity

20

rerun volume*

Factor

1.00

2.0

Absorbance limits

0

0 0 106

0 sec

Sample Sample blank

No normal volume


3.0

µL

µl



3 rerun volume* µL

318

Absorbance

0.500

-

2.000

Abs

R. Absorbance

-0.050

-

0.300

Abs

Substrate depletion

3.000

0

0

µL

0

µl


µL

80

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1


-

Repeats

3

Interval

14

Auto predilution

No

0 0

0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


Abs

µl



%

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-URSLbi-1 90/123

UREA UV SL TWO-REAGENT PROCEDURE Ref : Instruction for use :



8 x 25 mL 2 x 62.5 mL 4 x 62.5 mL 4 x 55 mL

5x 2x 4x 5x

125 mL 62.5 mL +STD 62.5 mL +STD 125 mL +STD


APPLICATION 0

0

FAUX

PERFORMANCES DATA Analytical range The reagent is linear from 10 to 300 mg/dL.



N 20 20 20


Mean (mg/dL) 14 63 159


CV% 2.9% 1.0% 0.7%


N 20 20 20

Mean (mg/dL) 15 63 160

CV% 3.9% 1.9% 1.2%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific E on 30 human sera samples. The sample concentrations were between 11 and 348 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9978 Linear regression : y= 0.9098 x + 4 mg/dL



 Modification


(05/2009) AA-PROXS/EL80-URSLbi-1 91/123

UREA UV Ref :

URUV-0400 URUV-0500

9 x 50 mL 6 x 100 mL



APPLICATION General

Sample types

Name

UREA UV

Normal

Abbreviated name

URUV

Allowed

Yes

Predilution

No

Code


PROPOSAL

Mode

Two point

Wavelength

340

0

Reference values nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


50

Calibrator name

XXX

-

300

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

UREA UV

Predilution

No

0

Slope Blank

No

Point one, two

24

0 0 103

0 sec

Sample Sample blank

No

0

normal volume


3.0

µL

rerun volume*

Factor

2.0

Absorbance limits

µl



3 rerun volume* µL

301

1.00

Absorbance

0.000

-

2.200

Abs

R. Absorbance

1.100

-

2.200

Abs

R. Abs. deviation

0.200

Abs

µl


0

0

µL

0

µl


µL

0

µl

Calibrator


0

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

Predilution

Name

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

xxx

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Concentration xxx

Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-URUV-1 92/123

URIC ACID MONO SL Ref :


12 x 20 mL 6 x 50 mL 6 x 100 mL 4 x 250 mL 6 x 50 mL +STD 6 x 100 mL +STD 4 x 250 mL +STD


APPLICATION General


AUML-0250 AUML-0420 AUML-0500 AUML-0700 AUML-0427 AUML-0507 AUML-0707

Sample types

Name

URIC ACID MONO SL

Normal

Abbreviated name

AUML

Allowed

Yes

Code

660

Predilution

No

Mode


Reference values

Wavelength

546

nm

0

Male

0

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

1

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


1.5

Calibrator name

XXX

-

25

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

URIC ACID MONO SL

Slope Blank

No

Predilution

No

Incubation time

4.5

0

0 min

0 0

Sample Sample blank

No

0

normal volume


6.0

µL

rerun volume*

Factor

2.0

Absorbance limits

µl



3 rerun volume*

Absorbance

0.000

-

1.000

Abs

R. Absorbance

0.000

-

0.100

Abs

250

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

28

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-AUML-1 93/123

URIC ACID MONO SL Ref :

AUML-0250 AUML-0420 AUML-0500 AUML-0700 AUML-0427 AUML-0507 AUML-0707


12 x 20 mL 6 x 50 mL 6 x 100 mL 4 x 250 mL 6 x 50 mL +STD 6 x 100 mL +STD 4 x 250 mL +STD


APPLICATION 0

0

FAUX




N 20 20 20


Mean (mg/dL) 2.5 4.8 7.8


CV% 0.5% 0.7% 0.5%


N 20 20 20

Mean (mg/dL) 2.5 4.7 7.8

CV% 0.8% 0.8% 1.2%


Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :No significant interference up to 36 mg/dL. Conjugated bilirubin :No significant interference up to 25 mg/dL. Haemoglobin: Positive bias from 100 mg/dL on normal human serum and from 350 mg/dL on pathological human serum. Turbidity :Positive bias from 263 mg/dL Triglycerides equivalent. Ascorbic acid:Negative bias from less than 1.5mg/dL (negative bias up to 40%). Glucose: No significant interference up to 500 mg/dL. Other compounds may interfere (see product insert).


Modification


(05/2009) AA-PROXS/EL80-AUML-1 94/123

URIC ACID SL ONE-REAGENT PROCEDURE Ref : Instruction for use :

2 x 62.5 mL 4 x 62.5 mL 5 x 125 mL


APPLICATION General

Sample types

Name

URIC ACID SL

Normal

Abbreviated name

AUSL

Allowed

Yes

Predilution

No

Code


AUSL-0400 AUSL-0420 AUSL-0600

Mode


Wavelength

546

0

Reference values

nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

1

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


2

Calibrator name

XXX

-

25

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

URIC ACID SL

Predilution

No

0

Slope Blank

No

Incubation time

4.5

0 min

0 0

Sample Sample blank

No

0

normal volume


6.0

µL

rerun volume*

Factor

3.0

Absorbance limits

µl



3 rerun volume*

Absorbance

0.000

-

3.000

Abs

R. Absorbance

0.000

-

0.400

Abs

253

9.000

0

0

µL

0

µl


µL

0

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

28

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Predilution

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-AUSLmono-1 95/123

URIC ACID SL ONE-REAGENT PROCEDURE PROCEDURE Ref :

AU AUSL-04 L-0400 AU AUSL-04 L-0420 AU AUSL-06 L-0600


2 x 62.5 mL 4 x 62.5 62. 5 mL 5 x 125 mL


APPLICATION 0

0

FAUX

PERFORMANCE PERFORMANCE DATA Analy An alytiti cal range ran ge The reagent is linear from 2 to 25 mg/dL.

Detection Detection limi t Determined according to SFBC protocol, the detection limit is equal to 0.04 mg/dL.

Precision Wi t hi n run reproduci bi l i ty

N 20 20 20


Mean (mg/dL) 2.5 4.4 7.0

Bet ween run reproduci bi l i ty

CV% 0.6% 0.6% 0.7%


N 20 20 20

Mean (mg/dL) 2.5 4.6 7.7

CV% 1.2% 1.4% 1.4%

Correlation A comparati rativ ve stud tudy has been perfo rformed betwe tween Selec lectra tra ProX roXS / Flex lexor EL80 and Vita ital Scien ientifi tific c XL on 30 human sera samples les. The sample concentrations were between 0.5 and 23.8 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9998 Linear regression : y= 0.9912 x + 0.04 mg/dL

Interferences Ac Accordin rding g to SFBC rec recommendatio tions some stud tudies ies have been perfo rformed to determ termine ine the the lev level of inte interf rfe eren rence from different different compounds: pounds: Unconjugated bilirubin :No significant interference up to 36 mg/dL. Conjugated bilirubin :No significant interference up to 25 mg/dL. Haemoglobin: Positive bias from 100 mg/dL on normal human serum and from 400 mg/dL on pathological human serum. Turbidity Turbidi ty :Positi :Positive ve bias from 263 mg/dL Triglyceri Triglycerides des equivalent on normal human serum human serum and from from 380 mg/dL Triglycerides equivalent on pathological human serum. As Ascorbic rbic acid:N id:Negativ tive bias ias fro from les less tha than 1.5m .5mg/dL /dL (ne (negativ tive bias ias up to 25%). Glucose: No significant interference up to 550 mg/dL. Other compounds may interfere (see product insert).


 Modification


(05/2009) AA AA-PROXS/EL /EL80-AUSLmono-1 96/123

URIC ACID SL TWO-REAGENT PROCEDURE PROCEDURE Ref : Instruction for use :

8 x 25 mL 2 x 62.5 62. 5 mL 4 x 62.5 mL 5 x 125 mL




AU AUSL-02 L-0250 AU AUSL-04 L-0400 AU AUSL-04 L-0420 AU AUSL-06 L-0600

Sam p l e t y p es

Name

URIC ACID SL

Normal

Ab Abbrev breviate iated d name

AUSL

Allowed

Yes

Code

680

Predilution

No

Mode


Reference values

Wavelength

546

nm

0

Male

0

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

1

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


2

Calibrator name

XXX

-

25

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

Gen er al

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Meas u r em en t

Name

URIC ACID SL

Predilution

No

0

Slope Blank

No

Incubation time

6.5

0 min

0 0

Sample Sample blank

No

0

normal volume


6.0

µL

rerun volume*

Factor

3.0

Absorbance limits

µl



3 rerun volume*

Abs Absorba orbance

-0.0 -0.01 10

-

1.00 .000

Abs

R. Absorbance

-0.010

-

0. 0.050

Abs

253

9.000

0

0

µL

0

µl


µL

62

µl

Cal i b r a t o r

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

28

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0

Au Auto accep ccept cal calibra ibratio tion Concentration xxx

Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

Pr ed i l u t i o n

Name


0

µl



1.00

0 µL

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA AA-PROXS/EL /EL80-AUSLbi-1 i-1 97/123

URIC ACID SL TWO-REAGENT PROCEDURE PROCEDURE Ref :

AU AUSL-02 L-0250 AU AUSL-04 L-0400 AU AUSL-04 L-0420 AU AUSL-06 L-0600


8 x 25 mL 2 x 62.5 62. 5 mL 4 x 62.5 mL 5 x 125 mL


APPLICATION 0

0

FAUX

PERFORMANCE PERFORMANCE DATA Analy An alytiti cal range ran ge The reagent is linear from 2 to 25 mg/dL.

Detection Detection limi t Determined according to SFBC protocol, the detection limit is equal to 0.04 mg/dL.


N 20 20 20


Mean (mg/dL) 2.5 4.8 7.9


CV% 0.7% 0.9% 0.4%


N 20 20 20

Mean (mg/dL) 2.5 4.7 7.9

CV% 0.7% 0.8% 1.2%

Correlation A comparati rativ ve stud tudy has been perfo rformed betwe tween Selec lectra tra ProX roXS / Flex lexor EL80 and Vita ital Scien ientifi tific c XL on 30 human sera samples les. The sample concentrations were between 0.7 and 23.6 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9998 Linear regression : y= 1.0022 x + 0.008 mg/dL

Interferences Ac Accordin rding g to SFBC rec recommendatio tions some stud tudies ies have been perfo rformed to determ termine ine the the lev level of inte interf rfe eren rence from different different compounds: pounds: Unconjugated bilirubin :No significant interference up to 36 mg/dL. Conjugated bilirubin :Negative bias from 20 mg/dL. Haemoglobin: No significant up to 500 mg/dL Turbidity Turbidity :Negative :Negative bias from 263 mg/dL Tri Triglycer glycerides ides equivalent equivalent on normal human serum human serum and from 400 mg/dL Triglycerides equivalent on pathological human serum. As Ascorbic rbic acid:N id:Negativ tive bias ias fro from 3.6 mg/dL /dL. Glucose: No significant interference up to 550 mg/dL. Other compounds may interfere (see product insert).


 Modification


(05/2009) AA AA-PROXS/EL /EL80-AUSLbi-1 i-1 98/123

URIC ACID Ref :

ACUR-0200 ACUR-0400 ACUR-0600

12 x 20 mL 9 x 50 mL 6 x 100 mL



APPLICATION General

Sample types

Name

URIC ACID

Normal

Abbreviated name

ACUR

Allowed

Yes

Predilution

No

Code


PROPOSAL

Mode


Wavelength

505

0

Reference values

nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

2

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


0.3

Calibrator name

XXX

-

25

mg/dL

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

URIC ACID

Predilution

No

0

Slope Blank

No

Incubation time

4.5

0 min

0 0

Sample Sample blank

No

0

normal volume


6.0

µL

rerun volume*

Factor

3.0

Absorbance limits

µl



3 rerun volume*

1.00

Absorbance

-0.100

-

1.500

Abs

R. Absorbance

-0.100

-

0.100

Abs

0 µL

253

0

µl


0

0

µL

0

µl


µL

0

µl

Calibrator


0

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

Predilution

Name

XXX

Number of standards

1

0


-

0

Repeats

3

Interval

xxx

Auto predilution

No 0

Cut-off

days

Cut-off

Curvefit

No 0

0

0

0

0


Concentration

Yes

0 0

0 FAUX FAUX

0

0

FAUX

0 0 0 0 0

0 0 0 0 0


 Modification

0

0


0

0

9.000

9.000

0

9.000

9.000


(05/2009) AA-PROXS/EL80-ACUR-1 99/123

APOA1 IP Ref : IAPA-0400

R1: 2x25 mL + R2: 1x 5 mL



APPLICATION General

Sample types

Name

APOA1 IP

Abbreviated name

Normal

APOA1

Code


Mode

Two point

Wavelength

340

Allowed

Yes

Predilution

No

0

Reference values nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls

Concentration limits Calibrator name

0

-

conc Std #6 mg/dL

APOA1/B IP CAL H

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

APOA1 IP

Predilution

Yes

1: 20

Slope Blank

No

Point one, two

-3

0 0 236

0 sec

Sample Sample blank

No

0

normal volume


6.0

rerun volume* µL

3.0

µl


No normal volume Reagent addition at - 2.25 minutes (R1) 220


-0.100

-

3.000

Abs

R. Absorbance

-0.100

-

0.300

Abs

Substrate depletion

0.000

Abs

rerun volume* µL

223

µl


0

0

µL

0

µl


µL

30

µl

Calibrator

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

Auto predilution

Yes

Number of standards

APOA1/B IP CAL H 6

Number of points

6


-

Sample Predilution

Yes

Repeats

1

Interval

14

Smoothed cubic spline

Max. inaccuracy

1.000


No

Modification

1: 20

0 Calibration limits

Algorithm

Standard Standard #1 Standard #2 Standard #3 Standard #4 Standard #5 Standard #6

0

0 days

Curvefit

N° #1 #2 #3 #4 #5 #6 0 0

0

Predilution

Name


0

Concentration 0.000 xxx xxx xxx xxx xxx

Low

%

Predilution No Yes Yes Yes Yes Yes


0 1: 1: 1: 1: 1: 0 0

High

Absorbance

0.000

%

0.000

%

Concentration

0.000

%

0.000

%

XXX: Enter data by the user * : For information only 20 20 20 20 20

APOA1/B IP CALIBRA TOR H: Use pur and diluted at 1/2,1/4,1/8,1/16 in NaCl 9g/L solution. Add a zero point (NaCl 9g/L solution). FAUX

(05/2009) AA-PROXS/EL80-IAPA-1 100/123

APOA1 IP Ref : IAPA-0400

R1: 2x25 mL + R2: 1x 5 mL



APPLICATION 0

0

FAUX

PERFORMANCE DATA Analyti cal range The reagent is linear from 10 to 350 mg/dL. The exact range depends on the value of the value of the calibrator used.

Hook effect No risk of error linked to hook effect up to 5000 mg/dL.



N 20 20 20


Mean (mg/dL) 51 123 242


CV% 3.3% 1.6% 1.8%

Level 1 Level 2

N 20 20

Mean (mg/dL) 54 127

CV% 7.8% 3.1%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific XL on 30 human sera samples. The sample concentrations were between 3 and 274 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9934 Linear regression : y= 1.0058 x + 3.5 mg/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :No significant interference up to 36 mg/dL. Conjugated bilirubin :No significant interference up to 25 mg/dL. Haemoglobin: No significant interference up to 500 mg/dL. Turbidity :No significant interference up to 614 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert).


Modification


(05/2009) AA-PROXS/EL80-IAPA-1 101/123

APOB IP Ref : IAPB-0400

R1: 2x25 mL + R2: 1x 5 mL



APPLICATION General

Sample types

Name

APOB IP

Abbreviated name

Normal

APOB

Code


Mode

Two point

Wavelength

340

Allowed

Yes

Predilution

No

0

Reference values nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls

Concentration limits Calibrator name

0

-

conc Std #6 mg/dL

APOA1/B IP CAL H

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

APOB IP

Predilution

Yes

1: 20

Slope Blank

No

Point one, two

-3

0 0 236

0 sec

Sample Sample blank

No

0

normal volume


15.0

rerun volume* µL

7.0

µl




-0.100

-

3.000

Abs

R. Absorbance

-0.100

-

0.300

Abs

Substrate depletion

0.000

Abs

rerun volume* µL

228

µl


0

0

µL

0

µl


µL

30

µl

Calibrator

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

Auto predilution

Yes

Number of standards

APOA1/B IP CAL H 6

Number of points

6


-

Sample Predilution

Yes

Repeats

1

Interval

14


Max. inaccuracy

1.000


No

Modification

1: 20


Algorithm


0

0 days

Curvefit

N° #1 #2 #3 #4 #5 #6 0 0

0

Predilution

Name


0


Low

%



0 1: 1: 1: 1: 1: 0 0

High

Absorbance

0.000

%

0.000

%

Concentration

0.000

%

0.000

%


APOA1/B IP CALIBRA TOR H: Use pur and diluted at 1/2,1/4,1/8,1/16 in NaCl 9g/L solution. In both cases, add a zero point (NaCl 9g/L solution). FAUX

(05/2009) AA-PROXS/EL80-IAPB-1 102/123

APOB IP Ref : IAPB-0400

R1: 2x25 mL + R2: 1x 5 mL



APPLICATION 0

0

FAUX





N 20 20 20


Mean (mg/dL) 52 98 262


CV% 2.8% 1.8% 1.7%

Level 1 Level 2

N 20 20

Mean (mg/dL) 53 98

CV% 5.2% 3.2%




Modification


(05/2009) AA-PROXS/EL80-IAPB-1 103/123

CRP IP Ref : ICRP-0400

R1: 2x25 mL + R2: 1x 5 mL



APPLICATION General

Sample types

Name

CRP IP

Normal

Abbreviated name

CRP

Allowed

Yes

Predilution

No

Code


Mode

Two point

Wavelength

340

0

Reference values nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

2

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


0

-

conc Std #6 mg/dL

Calibrator name

CRP IP CAL SET or CRP IP CAL H

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

CRP IP

Predilution

No

0

Slope Blank

No

Point one, two

-3

0 0 236

0 sec

Sample Sample blank

No

0

normal volume


16.0

rerun volume* µL

8.0

µl




-0.100

-

3.000

Abs

R. Absorbance

-0.100

-

0.300

Abs

Substrate depletion

0.000

Abs

rerun volume* µL

258

µl


0

0

µL

0

µl


µL

25

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

Name

CRP IP CAL SET or CRP IP CAL H

Number of standards

6

0


-

0

Repeats

1

Interval

21

No 0



Max. inaccuracy

1.000


No

Modification

Auto predilution

days

Algorithm

Used Standard #1 Standard #2 Standard #3 Standard #4 Standard #5 Standard #6

0

Predilution

Curvefit

N° #1 #2 #3 #4 #5 #6 0 0

0


Low

%

0


0 0 0 0 0 0 0 0

0 FAUX FAUX FAUX FAUX FAUX FAUX FAUX FAUX

High

Absorbance

0.000

%

0.000

%

Concentration

0.000

%

0.000

%

XXX: Enter data by the user * : For information only CRP IP CALIBRA TOR SET: Ready to use CRP IP CALIBRA TOR H: Use pur and diluted at 1/2,1/4,1/8,1/16 in NaCl 9g/L solution. In both cases, add a zero point (NaCl 9g/L solution).

(05/2009) AA-PROXS/EL80-ICRP-1 104/123

CRP IP Ref : ICRP-0400

R1: 2x25 mL + R2: 1x 5 mL



APPLICATION 0

0

FAUX

PERFORMANCE DATA Analyti cal range The reagent is linear from 0.5 to 22 mg/dL. The exact range depends on the value of the value of the calibrator used.




N 19 19 20


Mean (mg/dL) 1.87 3.48 10.27


CV% 3.7% 3.6% 1.4%


N 20 20 20

Mean (mg/dL) 1.93 3.73 10.50

CV% 5.3% 3.7% 1.9%




Modification


(05/2009) AA-PROXS/EL80-ICRP-1 105/123

HAPTOGLOBIN IP Ref : IHAP-0400

R1: 2x25 mL +R2: 1x 5mL



APPLICATION General

Sample types

Name

HAPTOGLOBIN IP

Normal

Abbreviatedname

IHAP

Allowed

Yes

Predilution

No

Code


Mode

Two point

Wavelength

340

Units

mg/dL

0

Reference values nm

0

Male

XXX

-

XXX

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls

-

conc Std #6 mg/dL

Control 1

XXX


0

Control 2

XXX

Calibrator name

PROTIP CAL SET or PROTIP CAL H

Control 3

XXX

Prozone check

No

Correlation factor

1.000

Correlation offset

0.000

Correlation

General

mg/dL

Measurement

Name

HAPTOGLOBIN IP

Predilution

No

0

Slope Blank

No

Point one, two

-3

0 0 236

0 sec

Sample Sample blank

No

0

normal volume


2.0

rerun volume* µL

1.0

µl




-0.100

-

3.000

Abs

R. Absorbance

-0.100

-

0.300

Abs

Substrate depletion

0.000

rerun volume* µL

281

0

0

µL

0

µl


µL

40

µl

Calibrator

0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

Name

PROTIP CAL SET or PROTIP CAL H

Number of standards

6

0


-

0

Repeats

1

Interval

14

No 0



Max. inaccuracy

1.000


No

Modification

Auto predilution

days

Algorithm


0

Predilution

Curvefit

N° #1 #2 #3 #4 #5 #6 0 0

Abs

µl



0


Low

%

0


0 0 0 0 0 0 0 0


High

Absorbance

0.000

%

0.000

%

Concentration

0.000

%

0.000

%


PROT IP CALIBRATOR SET: Ready to use PROT IP CALIBRATOR H: Use pur and diluted at 1/2,1/4,1/8,1/16 in NaCl 9g/L solution. In both cases, add a zero point (NaCl 9g/L solution).

(05/2009) AA-PROXS/EL80-IHAP-1 106/123

HAPTOGLOBIN IP Ref : IHAP-0400

R1: 2x25 mL +R2: 1x 5mL



APPLICATION 0

0

FAUX

PERFORMANCE DATA Analytical range The reagent is linear from 25 to 380 mg/dL. The exact range depends on the value of the value of the calibrator used.




N 20 20 20


Mean (mg/dL) 50 143 199


CV% 2.0% 1.3% 1.4%


N 20 20 20

Mean (mg/dL) 55 148 202

CV% 2.8% 2.2% 2.7%


Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :No significant interference up to 36 mg/dL. Conjugated bilirubin :No significant interference up to 25 mg/dL. Haemoglobin: Negative bias from 150 mg/dL.As the physiological function of haptoglobin is to bind free hemoglobin, addition of hemoglobin leads to the formation of Hp-Hb complexeshis leads to falsely decreased results by 14% to 20%. Turbidity :No significant interference up to 614 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert).


Modification


(05/2009) AA-PROXS/EL80-IHAP-1 107/123

HbA1c MANUAL LYSE Ref :

HBAC-0240

1 x 32 mL



APPLICATION General

Sample types

Name

HbA1c

Abbreviated name

HBAC

Normal

Code


Mode

Two point

Wavelength

660

Allowed

Yes

Predilution

No

0

Reference values nm

0

Male

XXX

-

XXX

%

Units

%

Female

XXX

-

XXX

%

Decimals

1

Pediatric

XXX

-

XXX

%

Test repeats

1

Panic

XXX

-

XXX

%

Controls


2.5

Calibrator name

HbA1c Calibrator Set

-

16

%

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

%

Measurement

Name

HbA1c

Predilution

No

0

Slope Blank

No

Point one, two

-287

0 0 236

0 sec

Sample Sample blank

No

0

normal volume


6.0

rerun volume* µL

6.0

µl

Absorbance limits



Absorbance

0.000

-

3.000

Abs

R. Absorbance

0.000

-

0.600

Abs

Substrate depletion

3.000

Abs

rerun volume* µL

225

µl


0

0

µL

0

µl

µL

75

µl


Calibrator

0

9.000

0

9.000

0

9.000

HbA1c Calibrator Set

Auto predilution

Number of standards

5

0


-

0

Repeats

1

Interval

7

days

0 9.000

0

0

No 0

Calibration limits

Algorithm

4PLL


No

Low Absorbance

Used Standard #1 Standard #2 Standard #3 Standard #4 Standard #5

Modification

0

0

Curvefit

N° #1 #2 #3 #4 #5 0 0 0

0 9.000

Predilution

Name


0

Concentration 0.000 xxx xxx xxx xxx


Concentration 0 0 0 0 0 0 0 0 0


High

0.000

%

0.000

%

0.000

%

0.000

%

XXX: Enter data by the user * : For information only Standard #1 Standard #2 Standard #3 Standard #4 Standard #5

NaCl 9 g/L HbA1c Calibrator set HbA1c Calibrator set HbA1c Calibrator set HbA1c Calibrator set

CAL 1 CAL 2 CAL 3 CAL 4

(05/2009) AA-PROXS/EL80-HBAC-1 108/123

HbA1c MANUAL LYSE Ref :

HBAC-0240

1 x 32 mL


APPLICATION


0

0

FAUX

PREPARATION OF SAMPLES: Dispense 1 mL of reagent R3 in a plastic or glass tube. Add 20µL of well mixed blood sample (calibrator, control or patient sample). Allow to stand for 5 minutes or until lysis is complete.

PERFORMANCE DATA Analyti cal range Determined according to EP6-A protocol of CLSI The reagent is linear from 2.5 to 16%. The exact range depends on the calibrator set used. If the result is higher than 16% , report result as > 16%, do not dilute sample.


N 80 80 80


Mean (%) 4.4 6.7 9.5

Within-run CV% 1.1% 0.9% 1.0%

Total CV% 2.3% 1.9% 2.9%

Correlation Determined according to EP9-A2 protocol of CLSI. A comparative study has been performed between Selectra ProXS / Flexor EL80 and another commercial reagent on Cobas Mira on 40 human blood samples. The sample concentrations were between 4.6 and 14.0%. The parameters of linear regression are as follows : Correlation coefficient (r): 0.983 Linear regression: y= 0.923x +0.06 %

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin: No significant interference up to 600µmol/L (360mg/L; 36 mg/dL). Conjugated bilirubin: No significant interference up to 340µmol/L (200mg/L; 20 mg/dL). Turbidity: No significant interference up to 600mg/dL triglyceride equivalent (6 g/L; 6.9mmol/L) Other compounds may interfere (see product insert).

On board stability (refrigerated position) The reagents are stable 2 weeks on analyser with a new calibration every week.

Modification


(05/2009) AA-PROXS/EL80-HBAC-1 109/123

IgA IP Ref : IIGA-0400

R1: 2x25 mL + R2: 1x 5 mL



APPLICATION General

Sample types

Name

IgA IP

Normal

Abbreviated name

Ig

Allowed

Yes

Predilution

No

Code


Mode

Two point

Wavelength

340

0

Reference values nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


0

-

conc Std #6 mg/dL

Calibrator name

PROT IP CAL SET or PROT IP CAL H

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

IgA IP

Predilution

No

0

Slope Blank

No

Point one, two

-3

0 0 236

0 sec

Sample Sample blank

No

0

normal volume


2.0

rerun volume* µL

1.0

µl




-0.100

-

3.000

Abs

R. Absorbance

-0.100

-

0.300

Abs

Substrate depletion

0.000

Abs

rerun volume* µL

341

µl


0

0

µL

0

µl


µL

50

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

Name


Number of standards

6

0


-

0

Repeats

1

Interval

14

No 0



Max. inaccuracy

1.000


No

Modification

Auto predilution

days

Algorithm


0

Predilution

Curvefit

N° #1 #2 #3 #4 #5 #6 0 0

0


Low

%

0


0 0 0 0 0 0 0 0


High

Absorbance

0.000

%

0.000

%

Concentration

0.000

%

0.000

%

XXX: Enter data by the user * : For information only PROT IP CALIBRA TOR SET: Ready to use PROT IP CALIBRA TOR H: Use pur and diluted at 1/2,1/4,1/8,1/16 in NaCl 9g/L solution. In both cases, add a zero point (NaCl 9g/L solution).

(05/2009) AA-PROXS/EL80-IIGA-1 110/123

IgA IP Ref : IIGA-0400

R1: 2x25 mL + R2: 1x 5 mL



APPLICATION 0

0

FAUX





N 20 20 20


Mean (mg/dL) 103 213 307


CV% 2.0% 1.1% 1.5%


N 20 20 19

Mean (mg/dL) 116 229 318

CV% 3.9% 3.5% 3.2%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific XL on 30 human sera samples. The sample concentrations were between 6 and 608 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9990 Linear regression : y= 0.9669 x + 2 mg/dL



Modification


(05/2009) AA-PROXS/EL80-IIGA-1 111/123

IgG IP Ref : IIGG-0400

R1: 2x25 mL + R2: 1x 5 mL



APPLICATION General

Sample types

Name

IgG IP

Normal

Abbreviated name

IgG

Allowed

Yes

Predilution

No

Code


Mode

Two point

Wavelength

340

0

Reference values nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


0

-

conc Std #6 mg/dL

Calibrator name


Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

IgG IP

Predilution

Yes

1: 10

Slope Blank

No

Point one, two

-3

0 0 236

0 sec

Sample Sample blank

No

0

normal volume


5.0

rerun volume* µL

2.0

µl




-0.100

-

3.000

Abs

R. Absorbance

-0.100

-

0.300

Abs

Substrate depletion

0.000

Abs

rerun volume* µL

253

µl


0

0

µL

0

µl


µL

25

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

Name


Auto predilution

Yes

Number of standards

6

Number of points

6


-

Sample Predilution

Yes

Repeats

1

Interval

14



Max. inaccuracy

1.000


No

Modification

1: 10

0 days

Algorithm


0

Predilution

Curvefit

N° #1 #2 #3 #4 #5 #6 0 0

0


Low

%



0 1: 1: 1: 1: 1: 0 0

High

Absorbance

0.000

%

0.000

%

Concentration

0.000

%

0.000

%


PROT IP CALIBRA TOR SET: Ready to use PROT IP CALIBRA TOR H: Use pur and diluted at 1/2,1/4,1/8,1/16 in NaCl 9g/L solution. In both cases, add a zero point (NaCl 9g/L solution). FAUX FAUX

(05/2009) AA-PROXS/EL80-IIGG-1 112/123

IgG IP Ref : IIG IIGG-0400

R1: 2x 2x25 mL + R2: 1x 1x 5 mL



APPLICATION 0

0

FAUX

PERFORMANCE PERFORMANCE DATA Analy An alytiti cal range ran ge The reagent is linear from 200 to 2700 mg/dL. The exact range depends on the value of the value of the calibrator used.


Detection Detection limi t Determined according to SFBC protocol, the detection limit is equal to 16 mg/dL.


N 20 20 20


Mean (mg/dL) 505 1060 2336


CV% 1.8% 1.0% 1.5%


N 20 20 20

Mean (mg/dL) 513 1059 2171

CV% 5.0% 4.5% 2.9%

Correlation A comparati rativ ve stud tudy has been perfo rformed betwe tween Selec lectra tra ProX roXS / Flex lexor EL80 and Vita ital Scien ientifi tific c XL on 30 human sera samples les. The sample concentrations were between 94 and 2260 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9950 Linear regression : y= 1.0099 x - 40 mg/dL

Interferences Ac Accordin rding g to SFBC rec recommendatio tions some stud tudies ies have been perfo rformed to determ termine ine the the lev level of inte interf rfe eren rence from different different compounds: pounds: Unconjugated bilirubin :No significant interference up to 36 mg/dL. Conjugated bilirubin :No significant interference up to 25 mg/dL. Haemoglobin: No significant interference up to 500 mg/dL. Turbidity :No significant interference up to 614 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert).


Modification


(05/2009) AA AA-PROXS/EL /EL80-IIG -IIGG-1 113/123

IgM IP Ref : IIG IIGM-0400

R1: 2x 2x25 mL + R2: 1x 1x 5 mL




Sam p l e t y p es

Name

IgM IP

Normal

Ab Abbrev breviate iated d name

IgM IgM

Allowed

Yes

Predilution

No

Code


Mode

Two point

Wavelength

340

0

Reference values nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


0

-

conc Std #6 mg/dL

Calibrator name


Control 1

XXX

Control 2

XXX

Control 3

XXX


No

Gen er al

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Meas u r em en t

Name

IgM IP

Predilution

No

0

Slope Blank

No

Point one, two

-3

0 0 236

0 sec

Sample Sample blank

No

0

normal volume


2.0

rerun volume* µL

1.0

µl



Absorbance limits Abs Absorba orbance

-0.1 -0.10 00

-

3.00 .000

Abs

R. Absorbance

-0.100

-

0. 0.300

Abs

Substrate depletion

0.000

Abs

rerun volume* µL

301

µl


0

0

µL

0

µl


µL

40

µl

Cal i b r a t o r


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

Name


Number of standards

6

0


-

0

Repeats

1

Interval

14

No 0

0 Cal i b r at i o n l i m i t s


Max. inaccuracy

0.5

Au Auto accep ccept cal calibra ibratio tion

No

Modification

Auto predilution

days

Alg Algor orith ithm


0

Pr ed i l u t i o n

Cu r v ef i t

N° #1 #2 #3 #4 #5 #6 0 0

0


Low

%

0


0 0 0 0 0 0 0 0


High igh

Absorbance

0.000

%

0.000

%

Concentration

0.00 0.000

%

0.00 .000

%


(05/2009) AA AA-PROXS/EL /EL80-IIG -IIGM-1 114/123

IgM IP Ref : IIG IIGM-0400

R1: 2x 2x25 mL + R2: 1x 1x 5 mL



APPLICATION 0

0

FAUX

PERFORMANCE PERFORMANCE DATA Analy An alytiti cal range ran ge The reagent is linear from 20 to 380 mg/dL. The exact range depends on the value of the value of the calibrator used.


Detection Detection limi t Determined according to SFBC protocol, the detection limit is equal to 2 mg/dL.


N 20 20 20


Mean (mg/dL) 90 214 358


CV% 2.6% 1.6% 1.4%


N 20 20 20

Mean (mg/dL) 96 134 197

CV% 3.3% 2.8% 3.2%

Correlation A comparati rativ ve stud tudy has been perfo rformed betwe tween Selec lectra tra ProX roXS / Flex lexor EL80 and Vita ital Scien ientifi tific c XL on 30 human sera samples les. The sample concentrations were between 9 and 323 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9964 Linear regression : y= 1.0362 x - 5 mg/dL

Interferences Ac Accordin rding g to SFBC rec recommendatio tions some stud tudies ies have been perfo rformed to determ termine ine the the lev level of inte interf rfe eren rence from different different compounds: pounds: Unconjugated bilirubin :No significant interference up to 36 mg/dL. Conjugated bilirubin :No significant interference up to 25 mg/dL. Haemoglobin: No significant interference up to 500 mg/dL. Turbidity :No significant interference up to 550 mg/dL Triglycerides equivalent. Other compounds may interfere (see product insert).


Modification


(05/2009) AA AA-PROXS/EL /EL80-IIG -IIGM-1 115/123

µALBUMIN IP Ref : IMAL-0400

R1: 2x25 mL + R2: 1x 5 mL



APPLICATION General

Sample types

Name

µALBUMIN IP

Normal

Abbreviated name

IMAL

Allowed

Yes

Predilution

No

Code


Mode

Two point

Wavelength

340

0

Reference values nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

1

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


0

-

conc Std #6 mg/dL

Calibrator name

µALB IP CAL SET or µALB IP CAL H

Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

µALBUMIN IP

Predilution

No

0

Slope Blank

No

Point one, two

-3

0 0 236

0 sec

Sample Sample blank

No

0

normal volume


16.0

rerun volume* µL

8.0

µl




-0.100

-

3.000

Abs

R. Absorbance

-0.100

-

0.300

Abs

Substrate depletion

0.000

Abs

rerun volume* µL

258

µl


0

0

µL

0

µl


µL

40

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

Name

µALB IP CAL SET or µALB IP CAL H

Number of standards

6

0


-

0

Repeats

1

Interval

14

No 0



Max. inaccuracy

1.000


No

Modification

Auto predilution

days

Algorithm


0

Predilution

Curvefit

N° #1 #2 #3 #4 #5 #6 0 0

0


Low

%

0


0 0 0 0 0 0 0 0


High

Absorbance

0.000

%

0.000

%

Concentration

0.000

%

0.000

%

XXX: Enter data by the user * : For information only µALBUMIN IP CALIBRA TOR SET: Ready to use. µALBUMIN IP CALIBRA TOR H: Use pur and diluted at 1/2,1/4,1/8,1/16 in NaCl 9g/L solution. In both cases, add a zero point (NaCl 9g/L solution).

(05/2009) AA-PROXS/EL80-IMAL-1 116/123

µALBUMIN IP Ref : IMAL-0400

R1: 2x25 mL + R2: 1x 5 mL



APPLICATION 0

0

FAUX

PERFORMANCE DATA Analyti cal range The reagent is linear from 0.3 to 40 mg/dL. The exact range depends on the value of the value of the calibrator used.




N 20 20 20


Mean (mg/dL) 2.5 5.0 21.6


CV% 2.6% 1.3% 2.3%


N 20 20 20

Mean (mg/dL) 2.8 5.5 21.9

CV% 4.1% 4.9% 2.6%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific XL on 33 human urine samples. The sample concentrations were between 0.49 and 34.29 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9817 Linear regression : y= 0.9119 x + 0.52 mg/dL

Interferences According to SFBC recommendations some studies have been performed to determine the level of interference from different compounds: Unconjugated bilirubin :No significant interference up to 36 mg/dL. Conjugated bilirubin :No significant interference up to 23 mg/dL. Haemoglobin: No significant interference up to 500 mg/dL. Other compounds may interfere (see product insert).


Modification


(05/2009) AA-PROXS/EL80-IMAL-1 117/123

OROSOMUCOID IP Ref : IORO-0400

R1: 2x25 mL + R2: 1x 5 mL



APPLICATION General

Sample types

Name

OROSOMUCOID IP

Normal

Abbreviated name

IORO

Allowed

Yes

Predilution

No

Code


Mode

Two point

Wavelength

340

0

Reference values nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


0

-

conc Std #6 mg/dL

Calibrator name


Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

OROSOMUCOID IP

Predilution

No

0

Slope Blank

No

Point one, two

-3

0 0 236

0 sec

Sample Sample blank

No

0

normal volume


2.0

rerun volume* µL

1.0

µl




-0.100

-

3.000

Abs

R. Absorbance

-0.100

-

0.300

Abs

Substrate depletion

0.000

Abs

rerun volume* µL

301

µl


0

0

µL

0

µl


µL

40

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

Name


Number of standards

6

0


-

0

Repeats

1

Interval

14

No 0



Max. inaccuracy

1.000


No

Modification

Auto predilution

days

Algorithm


0

Predilution

Curvefit

N° #1 #2 #3 #4 #5 #6 0 0

0


Low

%

0


0 0 0 0 0 0 0 0


High

Absorbance

0.000

%

0.000

%

Concentration

0.000

%

0.000

%


(05/2009) AA-PROXS/EL80-IORO-1 118/123

OROSOMUCOID IP Ref : IORO-0400

R1: 2x25 mL + R2: 1x 5 mL



APPLICATION 0

0

FAUX





N 20 20 20


Mean (mg/dL) 38 121 141


CV% 2.3% 1.7% 1.3%


N 20 20 20

Mean (mg/dL) 40 122 146

CV% 3.1% 3.3% 3.0%




Modification


(05/2009) AA-PROXS/EL80-IORO-1 119/123

PREALBUMIN IP Ref : IPAL-0400

R1: 2x25 mL + R2: 1x 5 mL



APPLICATION General

Sample types

Name

PREALBUMIN IP

Normal

Abbreviated name

IPAL

Allowed

Yes

Predilution

No

Code


Mode

Two point

Wavelength

340

0

Reference values nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


0

-

conc Std #6 mg/dL

Calibrator name


Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

PREALBUMIN IP

Predilution

No

0

Slope Blank

No

Point one, two

-3

0 0 236

0 sec

Sample Sample blank

No

0

normal volume


2.0

rerun volume* µL

1.0

µl




-0.100

-

3.000

Abs

R. Absorbance

-0.100

-

0.300

Abs

Substrate depletion

0.000

Abs

rerun volume* µL

221

µl


0

0

µL

0

µl


µL

20

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

Name


Number of standards

6

0


-

0

Repeats

1

Interval

14

No 0



Max. inaccuracy

1.000


No

Modification

Auto predilution

days

Algorithm


0

Predilution

Curvefit

N° #1 #2 #3 #4 #5 #6 0 0

0


Low

%

0


0 0 0 0 0 0 0 0


High

Absorbance

0.000

%

0.000

%

Concentration

0.000

%

0.000

%


(05/2009) AA-PROXS/EL80-IPAL-1 120/123

PREALBUMIN IP Ref : IPAL-0400

R1: 2x25 mL + R2: 1x 5 mL



APPLICATION 0

0

FAUX





N 20 20

Level 1 Level 2

Mean (mg/dL) 21 32


CV% 0.9% 1.1%

Level 1 Level 2

N 20 20

Mean (mg/dL) 22 34

CV% 3.0% 3.0%

Correlation A comparative study has been performed between Selectra ProXS / Flexor EL80 and Vital Scientific XL on 30 human sera samples. The sample concentrations were between 0.36 and 42 mg/dL. The parameters of linear regression are as follows : Correlation coefficient (r) :0.9988 Linear regression : y= 1.0734 x - 0.06 mg/dL



Modification


(05/2009) AA-PROXS/EL80-IPAL-1 121/123

TRANSFERRIN IP Ref : ITRF-0400

R1: 5x25 mL + R2: 1x 5 mL



APPLICATION General

Sample types

Name

TRANSFERRIN IP

Normal

Abbreviated name

TRF

Allowed

Yes

Predilution

No

Code


Mode

Two point

Wavelength

340

0

Reference values nm

0

Male

XXX

-

XXX

mg/dL

Units

mg/dL

Female

XXX

-

XXX

mg/dL

Decimals

0

Pediatric

XXX

-

XXX

mg/dL

Test repeats

1

Panic

XXX

-

XXX

mg/dL

Controls


0

-

conc Std #6 mg/dL

Calibrator name


Control 1

XXX

Control 2

XXX

Control 3

XXX


No

General

Correlation factor

1.000

Correlation offset

0.000

mg/dL

Measurement

Name

TRANSFERRIN IP

Predilution

Yes

1: 20

Slope Blank

No

Point one, two

-3

0 0 236

0 sec

Sample Sample blank

No

0

normal volume


3.0

rerun volume* µL

2.0

µl




-0.100

-

3.000

Abs

R. Absorbance

-0.100

-

0.300

Abs

Substrate depletion

0.000

Abs

rerun volume* µL

221

µl


0

0

µL

0

µl


µL

10

µl

Calibrator


0

9.000

0 9.000

0

0

9.000

0 9.000

0

0

9.000

Name


Auto predilution

Yes

Number of standards

6

Number of points

6


-

Sample Predilution

Yes

Repeats

1

Interval

14



Max. inaccuracy

1.000


No

Modification

1: 20

0 days

Algorithm


0

Predilution

Curvefit

N° #1 #2 #3 #4 #5 #6 0 0

0


Low

%



0 1: 1: 1: 1: 1: 0 0

High

Absorbance

0.000

%

0.000

%

Concentration

0.000

%

0.000

%


PROT IP CALIBRA TOR SET: Ready to use PROT IP CALIBRA TOR H: Use pur and diluted at 1/2,1/4,1/8,1/16 in NaCl 9g/L solution. In both cases, add a zero point (NaCl 9g/L solution). FAUX

(05/2009) AA-PROXS/EL80-ITRF-1 122/123

Selectra Pro XS, Flexor EL80 Manual Configuración de Reactivos

Recommend Documents