30 421-01
13765 D - en - 2015/06
®
VIDAS Creatine Kinase MB (CK-MB) (CK-MB) Te VIDAS® Creatine Kinase MB (CKMB) Assa! is inten"e" #$r %se $n te instr%&ents $# te VIDAS #a&i'! (Vite ® I&&%n$Dian$sti* Assa! S!ste&) as an a%t$&ate" en+!&e-'ine" ,%$res*ent i&&%n$assa! (.A) (.A) #$r te %antitatie "eter&inati$n $# *reatine inase MB is$en+!&e *$n*entrati$n in %&an ser%& $r 'as&a (earin $r DTA) DTA) It is inten"e" #$r %se as an ai" in te "ian$sis $# a*%te &!$*ar"ia' in#ar*ti$ns SMMA SMMA AD 89.AATI: : T; TST A iette ti-'ie "is$sa<'e "ei*e= te S$'i" 9ase e*eta*'e (S9® )= seres as a s$'i" ase #$r te assa! Creatine inase is a e! en+!&e $# &%s*'e &eta<$'is& It as >e'' as a iettin "ei*e Te S9 is *$ate" at te is resent in a'' tiss%es= <%t in aria<'e *$n*entrati$ns *$n*entrati$ns an" ti&e $# &an%#a*t%re &an%#a*t%re >it &$%se &$n$*'$na' anti-Creatine in "i?erent is$#$r&s (CKMM= CKMB= an" CKBB)(1) In Kinase MB anti<$"ies Te VIDAS Creatine Kinase MB se'eta' &%s*'e *reatine *reatine inase is essentia''! #$%n" in te (CK (C K MB) MB ) assa assa! ! *$n *$n% %ra rati ti$ $n re reen entts n$ns n$nse e* *i* i* MM is$#$r& (1) (1) Te BB is$#$r& is #$%n" re"$&inant'! re"$&inant'! in rea*ti$ns >it te S9 eaents #$r te assa! are te
as ste eart reares te S9 #$r te rea*ti$n ten te sa&'e is tiss%e (1=2) $# an! *$n*ent &%s*%'ar &%s* %'arsina's tra%&a an e'eati$n e'eat i$nIn te $# ae'' *$ntainin te sa&'e ne*r$ti* in@%r! t$ te te eart $**%rrin in *$nse%en*e t$ "i'%ent a Te sa&'e/sa&'e "i'%ent &it%re is *!*'e" in an" $%t $# &!$*ar"ia' $%rs a#ter in#ar*ti$n te $nsetenera''! $# *est CKMB ainsisa"ete*ta<'e n" ea e te CKMB >i'' eer= a a''$>s te *$n@%ate t$ atta* t$ te CKMB a'rea"! e" *ertain n%&i*G as as stes stes >i* an e'eati$n $# CKMB *an a'' >i'' *ata'!+e te *$nersi$n $# te s%
CKMB Ca'i
S9®
ea"!-t$-%se S9s *$ate" >it &$%se &$n$*'$na' anti-Creatine Kinase MB anti<$"ies
C1
e*$nstit%te >it 3 &' $# CKMB re*$nstit%ti$n s$'ent ait 10 t$ 15 &in%tes Mi Sta<'e a#ter re*$nstit%ti$n #$r 24 $%rs at 2-JC In a'i%$ts an" #r$+en at 25 L 6JC= sta<'e %nti' te eirati$n "ate $n it ie #ree+e/ta> *!*'es are $ssi<'e 9r$tein
S1
e*$nstit%te >it 3 &' $# CKMB re*$nstit%ti$n s$'ent ait 10 t$ 15 &in%tes Mi Sta<'e a#ter re*$nstit%ti$n #$r 24 $%rs at 2-JC In a'i%$ts an" #r$+en at 25 L 6JC= sta<'e %nti' te eirati$n "ate $n it ie #ree+e/ta> *!*'es are $ssi<'e 9r$tein
1 CKMB e*$nstit%ti$n e*$nstit%ti$n ea"!-t$-%se ; : >it 1 /. s$"i%& a+i"e s$'ent 1 20 &' 2 ('i%i") Se*i*ati$ns #$r te #a*t$r! &aster "ata re%ire" t$ *a'in'$a"a<'e #r$& >>>>>
1
VIDAS® Creatine Kinase MB (CKMB)
13765 D - en - 2015/06
Te S9®
Te stri Te S9 is *$ate" "%rin r$"%*ti$n >it &$n$*'$na' Te stri *$nsists $# 10 >e''s *$ere" >it a 'ai* &ain'! i"entie" e'' is er#$rate" t$ #a*i'itate $%* a#ter $enin te intr$"%*ti$n $# te sa&'e Te 'ast >e'' $# ea* stri is a *%ette in >i* te ,%$r$&etri* rea"in is er#$r&e" Te >e''s in te *enter se*ti$n $# te stri *$ntain te ari$%s Des*riti$n $# te Creatine Kinase MB (CKMB) eaent Stri F reaents re%ire" #$r te assa! e''s
eaents
1
Sa&'e >e''
2
Sa&'e Di'%entF 300 O' TIS <%?ere" sa'ine (005&$'/'= ; 74) >it r$tein an" *e&i*a' sta
3
9re>asF 600 O' TIS <%?ere" sa'ine (005 &$'/'= ; 74) >it r$tein sta
4-5 6 7-
asF 600 O' TIS <%?ere" sa'ine (005 &$'/'= ; 74) >it "eterent an" 1 /. s$"i%& a+i"e Dete*t$r Anti<$"! C$n@%ateF 400 O' $at anti-CKMM $'!*'$na' anti<$"ies *$n@%ate" t$ a'a'ine $satase >it 1 /. s$"i%& a+i"e asF 600 O' TIS <%?ere" sa'ine (005 &$'/'= ; 74) >it "eterent an" 1 /. s$"i%& a+i"e
P
&t! >e''
10
ea"in C%ette >it S%
Q Sina' $r"F DA
;a+ar" state&ent ;31 F Ca%ses seri$%s e!e "a&ae 9re*a%ti$nar! state&ent 920 Fear r$te*tie '$es/r$te*tie *'$tin/e!e r$te*ti$n/#a*e r$te*ti$n 9305 9351 933F I I SF inse *a%ti$%s'! >it >ater #$r seera' &in%tes e&$e *$nta*t 'enses= i# resent an" eas! t$ "$ C$ntin%e rinsin $r #%rter in#$r&ati$n= *$ns%'t te Sa#et! Data Seet MATIA.S ID BT :T 9:VIDD
N C$nsi"er a'' atient se*i&ens $tentia''! in#e*ti$%s an" $it "is$sa<'e tis >i* >i'' "isense 3 &' an" %se" *$&$nents an" $ter *$nta&inate" &ateria's "er'ess "is$sa<'e '$es %&an <'$$" r$"%*ts $r $ter se*i* &ateria's= 'ease re#er t$ te N Tis it *$ntains r$"%*ts $# ani&a' $riin Certie" Instr%&ent :erat$rEs Man%a' n$>'e"e $# te $riin an"/$r sanitar! state $# te Instr%&ent $# te VIDAS #a&i'! ani&a's "$es n$t t$ta''! %arantee te an ana'!sis &et$" *an t$ta''! %arantee te N 9$>"er'ess '$es are re*$&&en"e" as $>"er as ai* *an rea*t >it $it >ater t$ a$i" <%i'"-%
2
VIDAS® Creatine Kinase MB (CKMB)
13765 D - en - 2015/06
N Te rea"in *%ette >it s%e'' 10) *$ntainsAssa! an 9r$*e"%re irritant aent (66R "ietan$'a&ine) e#er t$ te a+ar" 1 e&$e ne*essar! *$&$nents #r$& te it an" state&ents G;G an" te re*a%ti$nar! state&ents G9Gret%rn a'' %n%se" *$&$nents t$ st$rae at 2-JC a<$e 2 se $ne GCKMBG stri an" $ne GCKMBG S9 #$r ea* N Si''s s$%'" ie" % t$r$%'! a#ter treat&ent sa&'e= *$ntr$' $r *a'iit 'i%i" "eterent an" a s$'%ti$n $# $%se$'" <'ea*te st$rae $%* as it te ar$riate r$*e"%res ar$riate sa&'e i"enti*ati$n n%&it te e*eti$n $# 6 $r tis test= te *a'iit te assa! *$"e $n te S9s Te CKMB S9 s are r$i"e" in a resea'a<'e $%* an" te eaent Stris &at* e&$e $n'! te re%ire" n%&i'' itin ar$i&ate'! S9CIM C:..CTI: AD 99AATI: 35 &in%tes A#ter te assa! is *$&'ete"= re&$e te A**eta<'e se*i&ens in*'%"e ser%& $r 'as&a (>it S9s an" stris #r$& te instr%&ent earin $r DTA anti*$a%'ant) Te %se $# eat11 Dis$se $# te %se" S9s an" stris int$ an ina*tiate" sera as n$t in I# ne*essar!= *'ari#! sa&'es it t$ *e* tat reaent er#$r&an*e as n$t i'' $n'! '$t $# reaents is %se"= enter te #r$& te ee*te" a'%es se*i*ati$ns ($r #a*t$r! &aster "ata) int$ te instr%&ent $te %sin &aster '$t entr! (M.) "ata I# tiste $erati$n is n$t er#$r&e" i'' n$t it an! '$*a' a'i*a<'e #$r ea* '$t re%'ati$ns It is $ssi<'e t$ enter M. "ata &an%a''! $r S.TS AD IT9TATI: a%t$&ati*a''! "een"in $n te instr%&ent (re#er t$ te T>$ instr%&ent rea"ins #$r ,%$res*en*e in te eaent serEs Man%a') StriUs rea"in *%ette are taen #$r ea* se*i&en Ca'i '$t $# reaents is $ene"= re&ainin $n te interi$r $# te S9 Te itin te set V Ge'atie '%$res*en*e Va'%eG rane I# tis is n$t te *ase= re*a'i
3
VIDAS® Creatine Kinase MB (CKMB)
13765 D - en - 2015/06
Te rane $# res%'ts #$r te VIDAS® Creatine Kinase MB Dete*ti$n 'i&it (CKMB) assa! is 0 - 300 n/&' Sa&'es >it res%'ts Te "ete*ti$n 'i&it (assa! sensitiit!) is "ene" as te 'ess tan 0 n/&' are re$rte" as G 0 n/&'G '$>est *$n*entrati$n tat *an it res%'ts reater tan 300 n/&' &%st>it i'' itin assa! rane (a 1/4 "i'%ti$n is re*$&&en"e" F 1 ;$$ e?e*t $'%&e $# sa&'e an" 3 $'%&es $# CKMB neatie sera) I# te "i'%ti$n #a*t$r as n$t en Te ;$$ e?e*t >as ea'%ate" %sin Creatine Kinase MB s$'%ti$ns >$se rese*tie *$n*entrati$ns >ere #r$& 06 te t$ 10=000 n/&' A rea*ti$n *%re 'atea% >as $i* re*$r"s F e?e*t >as seen % t$ 10=000 n/&' Creatine Kinase MB sa&'e *$n*entrati$n te t!e $# test er#$r&e"= ;::K CT : CKMB te sa&'e i"enti*ati$n= te "ate an" ti&e= te '$t n%&
V
I&&%n$'$i*a' Se*i*it! I&&%n$'$i*a' inter#eren*e >as teste" $ sa&'es *$ntainin 0P n/&' an" 1P2 n/&' $# Creatine Kinase MB rese*tie'! Teste" *$&$%n"
Cr$ss-rea*tiit! $r&a' er*entae ane $# Sa&'e eatie Ser%& 0P 0-164 053 eatie Ser%& an" CKBB SCI99S ('$t 607264=*atC1124) eatie Ser%& an" 0P3 CKMM SCI99S ('$t 755264=*atC1324) 9$sitie Ser%& 9$sitie Ser%& an" CKBB SCI99S ('$t 607264=*at1124) 9$sitie Ser%& an" CKMM SCI99S ('$t 755264=*atC1324)
1P2 1P37
---------------------W n/&'
Ca'i
116-1P6
13
$ inter#eren*e >as $it te *reatine inase is$#$r&s BB an" MM 9re*isi$n Intra-assa! rer$"%*iere teste" #$r intra-assa! re*isi$n Tirt! re'i*ates $# ea* sa&'e >ere teste" in te sa&e r%n Sa&'e
1
2
3
4
5
Mean *$n*entrati$n (n/&')
373
11P4
361
P47P
26536
62
34
43
33
34
R CV
4
VIDAS® Creatine Kinase MB (CKMB)
13765 D - en - 2015/06
Inter-assa! rer$"%*iere teste" in 23 r%ns $n te sa&e instr%&ent $er an ->ee eri$" (re*a'ias er#$r&e" eer! 14 "a!s as "es*ri
1
2
3
4
5
Mean *$n*entrati$n (n/&')
3P0
124P
3P3
P7
21P0
72
50
40
45
55
R CV
Inter-instr%&ent an" inter-assa! rer$"%*iere teste" in sin'et in P r%ns $n "i?erent instr%&ents Sa&'e
1
2
3
4
5
Mean *$n*entrati$n (n/&')
41
1257
346
P0
2754
167
45
47
37
57
R CV A**%ra*!
9ara''e'is& (Di'%ti$n tests)F Tree sa&'es >ere "i'%te" in *reatine inase MB neatie sera an" teste" in sin'et in 3 r%ns Sa&'e
1
2
3
e*te" &ean *$n*entrati$n (n/&')
Meas%re" &ean *$n*entrati$n (n/&')
1/1
2635
2635
100
1/2
1341
130P4
P
1/4
670
6535
P7
1/
3354
31
P5
1/16
1677
153
P4
1/32
3P
34
PP
1/1
2474
2474
100
1/2
14237
141P1
100
1/4
711P
7467
105
1/
355P
3505
P
1/16
170
173
105
1/32
P0
P37
105
1/1
P35
P35
100
1/2
467P
464
100
1/4
2340
2350
100
1/
1170
1166
100
1/16
55
605
103
1/32
2P2
332
114
Di'%ti$n #a*t$r
5
Mean re*$er! er*entae
VIDAS® Creatine Kinase MB (CKMB)
13765 D - en - 2015/06
e*$er! tests Tree sa&'es >ere sie" >it n$>n %antities $# *reatine inase MB is$en+!&e an" teste" in sin'et in tree instr%&ent r%ns Te &eas%re" &ean *$n*entrati$n *$&are" t$ te ee*te" &ean *$n*entrati$n is s$>n A&$%nt sie" (n/&')
Sa&'e
1
2
3
e*te" &ean *$n*entrati$n (n/&')
Meas%re" &ean *$n*entrati$n (n/&')
Mean re*$er! er*entae
0
041
041
100
207
24
21P
332
373
376
101
435
476
402
4
1046
107
77
1
511
5222
44P1
6
0
1104
1104
100
207
1311
130P
100
332
1435
12P1
P0
435
153
15P3
104
1046
2150
21P4
102
511
624
5651
P0
0
331
331
100
207
53
54P
102
332
662
6P0
104
435
765
7P2
104
1046
1377
1321
P6
511
5511
5070
P2
I.C : S9CIM C:..CTI: B'$$" sa&'es >ere *$''e*te" #r$& t>ent! eit atients $r ea* atient= 4 se*i&ens >ere *$''e*te" at te sa&e ti&eF in a "r! 'ass t%it a '!*er$'e" *aH in a t%it searatin e'H in a si'i*$ni+e" t%ere a's$ *$''e*te" #r$& eiteen atients an" *$''e*te" in a "r! 'ass t%it a '!*er$'e" *aH in a DTA t%as teste" in "%'i*ate an" sera #r$& te sa&e "$n$r >ere teste" in te sa&e r%n Te "r! 'ass t%it te '!*er$'e" *a >as te re#eren*e t$ >i* te $ter t%ere *$&are" C$''e*ti$n t%
%ati$n $# te 'ine
T%it searatin e'
101 -030
0PP
Si'i*$ne t%
102 -007
0PP
$n si'i*$ni+e" t%
112 -044
0PP
103 0076
0PP
0PP 0057
0PP
T%it DTA T%it earin ('iti%&)
C$rre'ati$n *$eX*ient
ITC STDIS ;earin T>$ $$'s $# %&an sera >ere sie" >it in*reasin %antities $# earin A&$%nt $# earin sie" (/&') 0
05
5
50
CKMB
9$$' 1
4
4
51
50
(n/&')
9$$' 2
P35
P57
P4P
P1
6
VIDAS® Creatine Kinase MB (CKMB)
13765 D - en - 2015/06
DTA T>$ $$'s $# %&an sera >ere sie" >it in*reasin %antities $# DTA A&$%nt $# DTA sie" (&/&') 0
1
5
10
CKMB
9$$' 1
4
51
50
4
(n/&')
9$$' 2
P35
P14
P15
P55
;e&$'$$ $$'s $# %&an sera >ere sie" >it in*reasin %antities $# e&$'$
125
25
50
100
500
1000
CKMB
9$$' 1
47
51
47
44
3P
37
54
(n/&')
9$$' 2
P26
P57
P50
P5P
P40
P1
P15
T%r$ $$'s $# %&an sera >ere sie" >it in*reasin %antities $# a 'ii" s$'%ti$n A&$%nt $# tri'!*eri"es sie" (/') 0
025
05
10
20
CKMB
9$$' 1
57
52
55
5P
54
(n/&')
9$$' 2
6P3
713
716
73
723
Aearan*e
C'ear
:a'es*ent
T%r
Bi'ir%$ $$'s $# %&an sera >ere sie" >it in*reasin %antities $#
12P
22
36
100
1500
1P25
CKMB
9$$' 1
64
5P
64
61
70
62
60
(n/&')
9$$' 2
50
04
05
72P
776
05
02
A't$% inter#eren*e 'ine" t$ te resen*e $# e&$'$ se*i&en 89CTD VA.S Te PPR *$n"en*e 'i&it #$r te n$r&a' rane $# CKMB teste" in 6 ea't! in"ii"%a's >as "eter&ine" t$ n ee*te" a'%es $n a >e''-"ene" $%'ati$n C:.ATI: ®
:ne %n"re" seent! e sa&'es >ere teste" >itin te rane $# 0 - 300 n/&' %sin te VIDAS *reatine inase MB (CKMB) Assa! an" a *$&&er*ia''! aai'a<'e IA Sa&'es >ere $n Y $# Sa&'es
S'$e
Inter*et
175
03
-0656
7
C$rre'ati$n *$eX*ient 0P7
VIDAS® Creatine Kinase MB (CKMB)
13765 D - en - 2015/06
AST DIS9:SA. ID8 : SMB:.S Dis$se $# %se" $r %n%se" reaents as >e'' as an! $ter S!&<$' Meanin *$nta&inate" "is$sa<'e &ateria's #$''$>in r$*e"%res #$r in#e*ti$%s $r $tentia''! in#e*ti$%s r$"%*ts Cata'$ n%&aste In Vitr$ Dian$sti* Me"i*a' Dei*e an" eZ%ents r$"%*e" a**$r"in t$ teir nat%re an" ($r ae te& treate" an" "is$se" $#) in te& Man%#a*t%rer "eree $# a+ar"$%sness a**$r"an*e >it an! a'i*a<'e an" re%'ati$ns t$ treat an" "is$se $# .ITAT CS 1 .an"t= = ; Vai"!a= S 9$rter= D Diet+ier= [ .a"ens$n 1PP I&&%n$aXnit! 9%ri*ati$n $# Creatine Kinase-MB #r$& ;%&an= D$= an" a<it se $# a M$n$*'$na' Anti<$"! Se*i* #$r CK-MB C'ini*a' Ce&istr! $' 35 n$ 6 P5-PP 2 een$= I= M Man*$n 1PP3 Interet A*t%e' "e 'a CK-MB "ans 'e Dian$sti*"e .Ein#a*t%s"% M!$*ar"e .!$n 9ar&a*e%ti%e 'seier= 9aris 3-P0 3 erar"t= = . .@%n"a'= 1PP3 ati$na' Dian$sti* Strate! in Dian$sis $# Is*e&i* M!$*ar"ia' In@%r! Str$$nin an" S-CKMB (&ass) Ti&es Series sin In"ii"%a' Base'ine Va'%es S*an" [ C'in .a< Inest 53(S%' 215) 47-5P
Te&erat%re 'i&it se
4 Ba!ana= V= S C$$e= .e%n= [a<'$ns!= A ;en"ers$n 1PP3 Dian$sti* a'%ati$n $# Creatine KinaseDate $# &an%#a*t%re 2 Mass an" Creatine Kinase-3 an" -2 Is$#$r& ati$s in ar'! Dian$sis $# A*%te M!$*ar"ia' In#ar*ti$n C'ini*a' Ce&istr!= AAT 4-4P5 5 .a&e= AS= ;[ 9eiterse-Br%ins= an" [C teranarranties= eress $r i&'ie" >arranties $# isser"ere 1P earin '$es as *a%se $# #a'se i&'ie"= in*'%"in an! MC;ATABI.IT AD ITSS : A neatie ;IV tests .an*et ii 1140-1144
9ATIC.A S
9art %&
$t a'i*a<'e (irst %<'i*ati$n) C$rre*ti$n $# "$*%&entati$n an$&a'ies A""iti$n= reisi$n an"/$r re&$a' $# in#$r&ati$n re'ate" t$ te r$"%*t I&'e&entati$n $# n$n-te*ni*a' *anes n$ti*ea<'e t$ te % ser Min$r t!$rai*a'= ra&&ar= an" #$r&attin *anes are n$t in*'%"e" in te reisi$n ist$r! Cane T!e A"&inistratie
2015/01
2015/06
13765C
13765D
Cane S%&&ar! ID8 : SMB:.S VISI: ;IST:
Te*ni*a'
KIT C:M9:SITI: (30 tests) AIS AD 9CATI:S
Te*ni*a'
KIT C:M9:SITI: (30 tests) ISTCTI:S : S
BI:MI8= te <'%e '$$= S9 an" VIDAS are %se"= en"in an"/$r reistere" tra"e&ars ner
>>>>
