Package_Insert_US_-_13765_-_D_-_en_-_30421-01

 30 421-01

13765 D - en - 2015/06

®

VIDAS Creatine Kinase MB (CK-MB) (CK-MB)  Te VIDAS® Creatine Kinase MB (CKMB) Assa! is inten"e" #$r %se $n te instr%&ents $# te VIDAS #a&i'! (Vite ® I&&%n$Dian$sti* Assa! S!ste&) as an a%t$&ate" en+!&e-'ine" ,%$res*ent i&&%n$assa! (.A) (.A) #$r te %antitatie "eter&inati$n $# *reatine inase MB is$en+!&e *$n*entrati$n in %&an ser%& $r 'as&a (earin $r DTA) DTA) It is inten"e" #$r %se as an ai" in te "ian$sis $# a*%te &!$*ar"ia' in#ar*ti$ns SMMA SMMA AD 89.AATI: : T; TST A iette ti-'ie "is$sae'' as a iettin "ei*e Te S9 is *$ate" at te is resent in a'' tiss%es= as ste eart reares te S9 #$r te rea*ti$n ten te sa&'e is tiss%e (1=2) $# an! *$n*ent &%s*%'ar &%s* %'arsina's tra%&a an e'eati$n e'eat i$nIn te $# ait 3 &' $# CKMB re*$nstit%ti$n s$'ent ait 10 t$ 15 &in%tes Mi Sta *!*'es are $ssiit &$n$*'$na'  Te stri *$nsists $# 10 >e''s *$ere" >it a 'ae''

2

Sa&'e Di'%entF 300 O' TIS it S%ater #$r seera' &in%tes e&$e *$nta*t 'enses= i# resent an" eas! t$ "$ C$ntin%e rinsin $r #%rter in#$r&ati$n= *$ns%'t te Sa#et! Data Seet MATIA.S ID BT :T 9:VIDD

N C$nsi"er a'' atient se*i&ens $tentia''! in#e*ti$%s an" $"er as ait >ater t$ a$i" itin ar$i&ate'! S9CIM C:..CTI: AD 99AATI: 35 &in%tes A#ter te assa! is *$&'ete"= re&$e te A**etain I# ne*essar!= *'ari#! sa&'es it t$ *e* tat reaent er#$r&an*e as n$t i'' n$t $ instr%&ent rea"ins #$r ,%$res*en*e in te eaent serEs Man%a') StriUs rea"in *%ette are taen #$r ea* se*i&en Ca'ias seen % t$ 10=000 n/&' Creatine Kinase MB sa&'e *$n*entrati$n  te t!e $# test er#$r&e"= ;::K CT : CKMB  te sa&'e i"enti*ati$n=  te "ate an" ti&e=  te '$t n%&it te *reatine inase is$#$r&s BB an" MM 9re*isi$n Intra-assa! rer$"%*iere teste" #$r intra-assa! re*isi$n Tirt! re'i*ates $# ea* sa&'e >ere teste" in te sa&e r%n Sa&'e

1

2

3

4

5

Mean *$n*entrati$n (n/&')

373

11P4

361

P47P

26536

62

34

43

33

34

R CV

4

VIDAS® Creatine Kinase MB (CKMB)

13765 D - en - 2015/06

Inter-assa! rer$"%*iere teste" in 23 r%ns $n te sa&e instr%&ent $er an ->ee eri$" (re*a'ias er#$r&e" eer! 14 "a!s as "es*riere "i'%te" in *reatine inase MB neatie 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

2635

2635

100

1/2

1341

130P4

P

1/4

670

6535

P7

1/

3354

31

P5

1/16

1677

153

P4

1/32

3P

34

PP

1/1

2474

2474

100

1/2

14237

141P1

100

1/4

711P

7467

105

1/

355P

3505

P

1/16

170

173

105

1/32

P0

P37

105

1/1

P35

P35

100

1/2

467P

464

100

1/4

2340

2350

100

1/

1170

1166

100

1/16

55

605

103

1/32

2P2

332

114

Di'%ti$n #a*t$r

5

Mean re*$er! er*entae

VIDAS® Creatine Kinase MB (CKMB)

13765 D - en - 2015/06

e*$er! tests  Tree sa&'es >ere sie" >it n$>n %antities $# *reatine inase MB is$en+!&e an" teste" in sin'et in tree instr%&ent r%ns Te &eas%re" &ean *$n*entrati$n *$&are" t$ te ee*te" &ean *$n*entrati$n is s$>n it in*reasin %antities $# earin A&$%nt $# earin sie" (/&') 0

05

5

50

CKMB

9$$' 1

4

4

51

50

(n/&')

9$$' 2

P35

P57

P4P

P1

6

VIDAS® Creatine Kinase MB (CKMB)

13765 D - en - 2015/06

DTA  T>$ $$'s $# %&an sera >ere sie" >it in*reasin %antities $# DTA A&$%nt $# DTA sie" (&/&') 0

1

5

10

CKMB

9$$' 1

4

51

50

4

(n/&')

9$$' 2

P35

P14

P15

P55

;e&$'$$ $$'s $# %&an sera >ere sie" >it in*reasin %antities $# e&$'$it in*reasin %antities $# a 'ii" s$'%ti$n A&$%nt $# tri'!*eri"es sie" (/') 0

025

05

10

20

CKMB

9$$' 1

57

52

55

5P

54

(n/&')

9$$' 2

6P3

713

716

73

723

Aearan*e

C'ear

:a'es*ent

T%rit in*reasin %antities $# e'' as an! $ter S!&