&-A+11-6* ,(2+?+
!"#$ !"#$"%&!&'
Pipette into cuvettes
Enzymatic Colorimetric Test for Urea &'()'*+ ,-.+/ 10505 !"#$% 6 10506 10507 10104
100 ml 1000 ml 1000 ml 9 x 3 ml
Sample/!0+(% Enzyme reagent 1a
Complete Test Kit Reagent 1, Enzyme, Standard Reagent 2 Standard
!&'(% 1, 2, 3
0+1234 Urea is hydrolysed in the presence of water and urease to produce ammonia and carbon dioxide. In a modified Berthelot reaction the ammonium ions react with hypochlorite and salicylate to form a green dye. The absorbance increase at 578 nm is proportional to the urea concentration in the sample. 5361+61/
!"#$% !"*+,% !"*+-% !#./% !0+(% !"*+,%
7898: 1000 ml
1 ml 3 ml
10 ml 3 ml
!#./%
!0+(%
1000 µl 1000 µl Mix, incubate for 10 min. at 20...25°C or for 5 min. at 37°C. Measure the absorbance of the sample ( ! A sample) and the !0+(% (! A !0+(%) against the reagent blank within 60 min.
5'C(EC'1-36 3F !@+' '64 G!H 536(+61@'1-36 ! Asample C = """"" x x factor ! A!0+(% I'(13@
5 J!"#$K
7878< F3@ !@-6+M
9 x 3 ml 120 mmol/l 60 mmol/l 5 mmol/l 1 mmol/l
"+'*+61 = Phosphate buffer (pH < 13) 120 mmol/l Hypochlorite ! #$% &'( )( Irritates eyes and skin. Keep out of reach of children. Upon contact with the eyes, rinse thoroughly with water and consult a doctor. #6.>?+ Urease > 500 KU/l ,1'64'@4 Urea equivalent to BUN Sodium azide
80 mg/dl or 13.3 mmol/l 37.28 mg/dl or 6.2 mmol/l 0.095 %
"+'*+61 &@+A'@'1-36
!"*+-% and !0+(% are ready for use. The Enzyme reagent 1a is prepared by mixing the contents of bottle
!#./% with bottle !"*+,%: e.g. 1 ml !#./% + 100 ml !"*+,% or 10 ml !#./% + 1000 ml !"*+,%
10 µl 1000 µl
!"*+-%
1000 ml
"+'*+61 7 Phosphate buffer (pH 7.0) Sodium salicylate Sodium nitroprusside EDT A
!"*+-%
7898;
!0+(%
Mix and incubate for 5 min. at 20...25°C or for 3 min. at 37°C.
F3@ ,+@E?LAC'/?' 78989 100 ml 100 ml
Sample or
Reagent blank --1000 µl
5 JG!HK
[mg/dl]
[mmol/l]
[mg/dl]
[mmol/l]
80
13.3
37.28
6.2
[g/l]
[mmol/l]
[g/l]
[mmol/l]
80.8
1343
37.65
626.2
536N+@/-36 I'(13@ F3@ G!HO !@+' 5 JG!HK P 8Q<:: R 5 J!@+'K 5 J!@+'K P =Q7< R 5 JG!HK &+@F3@?'6(+ 52'@'(1+@-/1-(/ Linearity Seru Serum/ m/pl pla asma: sma: up to 400 400 mg/d mg/dll or Urine: up to 400 g/l or
66.6 66.6 mmo mmol/l l/l (Ure (Urea a) 6600 mmol/l (Urea)
Samples with a higher urea concentration have to be diluted 1+1 with distilled water. Repeat the assay and multiply the results by 2. Typical performance date can be found in the Verification Report, accessible via www.human.de/data www.human.de/data/gb/vr/su-urlqc /gb/vr/su-urlqc .pdf or www.human-de.com/data/gb/vr/su-urlqc.pdf H3@?'C S'CE+/ Seru Serum m (Ure (Urea a): Urin Urine e (Ure (Urea a):
4, 5
10 - 50 mg/dl 20 - 35 g/24 /24 h
or 1.7 - 8.3 mmol mol/l or 333 333 - 583 583 mmo mmol/24 l/24 h
TE'C-1> 5361@3C All control control sera with urea or BUN values values determined determined by this method method may be employed. We recommend to use our animal serum based HUMATROL quality control sera or our human serum based SERODOS. $E13?'1-36 Proposals to apply the reagents reagents on analysers are available on request. Each laboratory has to validate the application in its own responsibility.
"+'*+61 ,1'B-C-1> The reagents are stable up to the stated expiry date when sealed and stored at 2...8°C. !"*+,%, !"*+-% and !#./% are stable after opening for 6 weeks at 2...8°C or = D++)/ at D++)/ at 15...25°C. !0+(% is stable up to the expiry date even after opening. The Enzyme reagent 1a is stable for < D++)/ at D++)/ at 2...8°C or = D++)/ at D++)/ at 15...25°C. Contamination Contamination after opening must be avoided.
H31+/ 1. The test test is not influenced influenced by by hemoglo hemoglobin bin up to 200 200 mg/dl and and by bilirubin up to 10 mg/dl. 2. !0+(% contains sodium azide (0.095%) as preservative. Do not swallow. Avoid contact with skin and mucous membranes. 3. !"*+-% contains sodium hypochlorite in alkaline solution. !"*+-% is irritant to eyes, skin and mucous membranes. In case of contact with eyes, skin and mucous membranes flush with copious amounts of water and consult a doctor.
,A+(-?+6 Serum, plasma, except ammonium heparinate plasma, and urine. Dilute urine 1 + 100 with distilled water. Do not use lipemic sera. Serum or plasma can be stored for up to 3 days at 4°C, for longer periods they should be kept fr ozen at -20°C.
"+F+@+6(+/ 1. Berthe Berthelot lot,, M., Report Report Chem. Chem. Appliqu Applique e 7, 284 (1859) 2. Fawcett Fawcett,, J.K., Scot Scott, t, J.E.; J.E.; J. Clin. Clin. Path. Path. 7U, 7U, 156 (1960) 3. Toba Tobacc cco o, A. A. !" $%&, Clin. Chem. =9 (2), =9 (2), 336 (1979) 4. MacKay MacKay,, E.M., MacKay MacKay,, L.L., L.L., J. Clin. Invest Invest.. <, 295 (1927) 5. Sarre H., Nierenkra Nierenkrankhe nkheiten, iten, Georg Georg Thieme Thieme Verlag Verlag Stuttgart Stuttgart (1959) 6. ISO 15223 Medical Medical devices devices - Symbols Symbols to be used with with medical medical device labels, labelling and information to be supplied
$//'> Wave Waveleng length th:: Optic al al path: Temp Temper erat ature ure:: Measureme Measurement: nt:
Hg 578 578 nm, nm, 570 570 - 600 600 nm 1 cm 20... 20...25 25°C °C or or 37°C 37°C Against Against reagent reagent blank. blank. Only one reage reagent nt blank per series is required.
SU-URLQC INF 1050501 GB 12-2003-15
!
Human Gesellschaft für Biochemica und Diagnostica mbH Max-Planck-Ring 21 - D-652 05 Wi esbaden - Germany Telefon: +49 6122 9988 0 - Telefax: +49 6122 9988 100 - eMail:
[email protected]
