Package_Insert_US_-_13765_-_D_-_en_-_30421-01

®

®

VIDAS

VIDAS Creatine

Creatine Kinase

Kinase MB

MB (CK

(CK-MB)

-MB)

 Te VIDAS®® Creatine Creatine Kinase Kinase MB MB (CKMB) (CKMB) Assa! Assa! is is inten"e" inten"e" #$r #$r %se %se $n $n te te instr%&ents instr%&ents $# $# te te VIDAS VIDAS #a&i'! #a&i'! (Vite(Vite®®

I&&%n$Dian$sti*

I&&%n$Dian$sti* Assa! Assa! S!ste&) S!ste&) as as an an a%t$&ate" a%t$&ate" en+!&e-'ine" en+!&e-'ine" ,%$res*ent ,%$res*ent i&&%n$assa! i&&%n$assa! (.(.A) A) #$r #$r tete %antitatie "eter&inati$n $#

%antitatie "eter&inati$n $# *reatine inase MB *reatine inase MB is$en+!&e *$n*entrati$n in is$en+!&e *$n*entrati$n in %&an %&an ser%& $r ser%& $r 'as&a (earin 'as&a (earin $r$r DT

DTA) It is inten"e" #$r A) It is inten"e" #$r %se as an ai" in %se as an ai" in te "ian$sis $# a*%te &!$*ar"ia' in#ar*ti$nste "ian$sis $# a*%te &!$*ar"ia' in#ar*ti$ns SMMA

SMMA AD 89.AATI: : T;  AD 89.AATI: : T; TSTTST A A iette iette ti-'ie ti-'ie "is$sa<'e "is$sa<'e "ei*e= "ei*e= te te S$'i" S$'i" 9ase9ase e*eta*'e

e*eta*'e (S9 (S9 )= seres )= seres as a as a s$'i" ase s$'i" ase #$r te #$r te assa!assa! as

as >e'' >e'' as as a a iettin iettin "ei*e "ei*e Te Te S9 S9 is is *$ate" *$ate" at at tete ti&e $# &an%#a*t%r

ti&e $# &an%#a*t%re >it e >it &$%se &$n$*'$na' &$%se &$n$*'$na' anti-Creatineanti-Creatine Kinase

Kinase MB MB anti<$"ies anti<$"ies Te Te VIDAS Creatine VIDAS Creatine Kinase Kinase MBMB

® ®

Creatine inase is

Creatine inase is a e! en+!&e $# a e! en+!&e $# &%s*'e &eta<$'is& It&%s*'e &eta<$'is& It is resent in

is resent in a'' tiss%es= a'' tiss%es= <%t in aria<'e *$n*e<%t in aria<'e *$n*entrati$ns an"ntrati$ns an" in "i?erent is$#$r&s (CKMM= CKMB= an" CKBB)(1) In in "i?erent is$#$r&s (CKMM= CKMB= an" CKBB)(1) In se'eta'

se'eta' &%s*'e *&%s*'e *reatine reatine inase is inase is essentia''! #$%n" essentia''! #$%n" in tein te MM is$#$r& (1)

MM is$#$r& (1) Te BB  Te BB is$#$r& is #$%n" ris$#$r& is #$%n" re"$&inant'! ine"$&inant'! in te <rain= an" te

te <rain= an" te MB #$r& is MB #$r& is #$%n" #$%n" rin*ia''! in terin*ia''! in te eart

eart

tiss%e (1=2)

tiss%e (1=2) In te a<sen*e In te a<sen*e $# an! &a@$r &%s*$# an! &a@$r &%s*%'ar tra%&a%'ar tra%&a (C

(CKKMBMB)) asassasa!! *$*$nn%%raratiti$$nn rreeenenttss n$n$nsnsee**ii** rea*ti$ns

rea*ti$ns >it >it te te S9 S9 eaents eaents #$r #$r te te assa! assa! areare '$*ate" in te sea'e" eaent Stris A re>as ste '$*ate" in te sea'e" eaent Stris A re>as ste reares te S9 #$r te rea*ti$n ten te sa&'e is reares te S9 #$r te rea*ti$n ten te sa&'e is trans#erre" int$ te >e'' *$ntainin te sa&'e

trans#erre" int$ te >e'' *$ntainin te sa&'e "i'%ent

"i'%ent

 Te sa&'e/sa&'e "i'%ent &it%re

 Te sa&'e/sa&'e "i'%ent &it%re is *!*'e" in an" $%t is *!*'e" in an" $%t $# $#  te S9

te S9 an" te an" te CKMB CKMB >i'' >i'' <in" t$ <in" t$ anti<$"ies anti<$"ies *$ate" *$ate" $n$n an

an e'eate'eati$n $# i$n $# ser%& ser%& CKMB *CKMB *$n*ent$n*entrati$n rati$n sinasina's's ne*r$ti*

ne*r$ti* in@%r! in@%r! t$ tt$ te eart e eart $**%rrin $**%rrin in *$nse%en*e in *$nse%en*e t$t$ a

a

&!$*ar"ia'

&!$*ar"ia' in#ar*ti$n in#ar*ti$n enera''! enera''! CKMB CKMB is is "ete*ta<'e "ete*ta<'e ee 

$$%%rrss aa##tteerr ttee $$nnsseett $$## **eesstt aaiinnss aann"" eeaa

te S9

te S9 as stes re&$e as stes re&$e %n<$%n" &ateria'%n<$%n" &ateria' Te Te *$n*entrati$ns

*$n*entrati$ns are are $#ten $#ten rea*e" rea*e" e'een e'een t$ t$ eiteeneiteen $%rs

$%rs a#ter a#ter te te in#ar*ti$n (3=4) in#ar*ti$n (3=4) Tere Tere eists $>eer= eists $>eer= aa *ertain n%&<er

*ertain n%&<er $# $ter $# $ter *$n"iti$ns= *$n"iti$ns= at$'$i*a' at$'$i*a' $r n$t= $r n$t= inin >i*

>i* an an e'eati$n e'eati$n $# $# CKMB CKMB *an *an <e <e $<sere"= $<sere"= s%* s%* asas D%*enneEs

D%*enneEs &%s*%'ar &%s*%'ar "!str$!= "!str$!= &%s*%'ar &%s*%'ar !era*tiit!=!era*tiit!= !$ an" !erter&ia= an"

!$ an" !erter&ia= an" &!$*ar"itis (2)&!$*ar"itis (2)

*$n@%ate is

*$n@%ate is ten ten *!*'e" in *!*'e" in an" an" $%t $$%t $# te # te S9 S9 Tis Tis steste a''$>s

a''$>s te te *$n@%ate *$n@%ate t$ t$ atta* atta* t$ t$ te te CKMB CKMB a'rea"! a'rea"! e"e" t$

t$ te te S9F S9F t%s t%s #$r&in #$r&in a a Gsan">i*G Gsan">i*G asas st steses re&$e %n<$%n" *$n@%ate

re&$e %n<$%n" *$n@%ate A

A ,%$res*ent s%<strate= ,%$res*ent s%<strate= 4-&et!'%&<e''i#er!' 4-&et!'%&<e''i#er!' $sate=$sate= is *!*'e" tr$% te S9 n+!&e re&ainin $n

is *!*'e" tr$% te S9 n+!&e re&ainin $n te S9te S9 >a''

>a'' >i'' >i'' *ata'!+e *ata'!+e te te *$nersi$n *$nersi$n $# $# te te s%<strate s%<strate t$ t$ tete ,%$res*ent

,%$res*ent r$"%*t r$"%*t 4-&et!'%&<e''i#er$ne Te 4-&et!'%&<e''i#er$ne Te intensit!intensit! $# ,%$res*

$# ,%$res*en*e is en*e is &eas%re" &eas%re" <! te <! te $ti*a' $ti*a' s*anner in s*anner in tete instr%&entH

instr%&entH it it is is r$$rti$na' r$$rti$na' t$ t$ te te Creatine Kinase Creatine Kinase MBMB *$n*entrati$n resent in te sa&'e

*$n*entrati$n resent in te sa&'e 9ICI9. : T; 9:CD

9ICI9. : T; 9:CD  Te

 Te VIDAS VIDAS Creatine Creatine Kinase Kinase MB MB (CKMB) (CKMB) assa! assa! is is anan en+!&e-'ine" ,%$res*ent i&&%n$assa! (.A) tat is en+!&e-'ine" ,%$res*ent i&&%n$assa! (.A) tat is er#$r&e" in

er#$r&e" in an an a%t$&ate" instr%&ent A'' a%t$&ate" instr%&ent A'' assa! stesassa! stes an" assa! te&erat%re are *$ntr$''e" <! te instr%&ent

an" assa! te&erat%re are *$ntr$''e" <! te instr%&enten en te te VIDAS VIDAS Creatine Creatine Kinase Kinase MB MB (CKMB) (CKMB) Assa! Assa! isis *$&'ete"=

*$&'ete"= te te res%'ts res%'ts are are ana'!+e" ana'!+e" a%t$&ati*a''! a%t$&ati*a''! <! <! tete instr%&ent= an" a re$rt is rinte"

instr%&ent= an" a re$rt is rinte" #$r ea* sa&'e#$r ea* sa&'e KIT C:M9:SITI: (30 TSTS)F

KIT C:M9:SITI: (30 TSTS)F 30 CKMB eaent

30 CKMB eaent Stris

Stris SSTT eeaa""!!--tt$$--%%ssee 30 CKMB S9s

30 CKMB S9s (1  30)

(1  30)

ea"!-t$-%se S9s *$ate" >it &$%se &$n$*'$na'

ea"!-t$-%se S9s *$ate" >it &$%se &$n$*'$na' anti-Creatine Kinase MBanti-Creatine Kinase MB anti<$"ies

anti<$"ies S9

S9®®

e*$nstit%te >it 3 &' $#

e*$nstit%te >it 3 &' $# CKMB re*$nstit%ti$n s$'ent ait 10 t$ 15 &in%tes Mi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

Sta<'e a#ter re*$nstit%ti$n #$r 24 $%rs at 2-JC In a'i%$ts an" #r$+en atan" #r$+en at 25 L 6JC= sta<'e %nti' te

25 L 6JC= sta<'e %nti' te eirati$n "ate $n it ie #ree+e/ta> *!*'es areeirati$n "ate $n it ie #ree+e/ta> *!*'es are $ssi<'e 9r$tein <ase (BSA)  *e&i*a' sta<i'i+ers  %&an

$ssi<'e 9r$tein <ase (BSA)  *e&i*a' sta<i'i+ers  %&an CKMB M. "ataCKMB M. "ata in"i*ate te *$n"en*e intera' in

in"i*ate te *$n"en*e intera' in n/&. (GC$ntr$' C1 D$se Va'%e aneG)n/&. (GC$ntr$' C1 D$se Va'%e aneG) CKMB C$ntr$'

CKMB C$ntr$'

1  3 &' ('!$i'i+e")

1  3 &' ('!$i'i+e") C1C1

e*$nstit%te >it 3 &' $#

e*$nstit%te >it 3 &' $# CKMB re*$nstit%ti$n s$'ent ait 10 t$ 15 &in%tes Mi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

Sta<'e a#ter re*$nstit%ti$n #$r 24 $%rs at 2-JC In a'i%$ts an" #r$+en atan" #r$+en at 25 L 6JC= sta<'e %nti' te

25 L 6JC= sta<'e %nti' te eirati$n "ate $n it ie #ree+e/ta> *!*'es areeirati$n "ate $n it ie #ree+e/ta> *!*'es are $ssi<'e 9r$tein <ase (BSA)  *e&i*a' sta<i'i+ers  %&an

$ssi<'e 9r$tein <ase (BSA)  *e&i*a' sta<i'i+ers  %&an CKMBCKMB CKMB Ca'i<rat$r CKMB Ca'i<rat$r 1  3 &' ('!$i'i+e") 1  3 &' ('!$i'i+e") S1S1 1 1

M. "ata in"i*ate te *a'i<rat$r

M. "ata in"i*ate te *a'i<rat$r titer in n/&. (GCa'i<rat$r (S1) D$se Va'%eG) an"titer in n/&. (GCa'i<rat$r (S1) D$se Va'%eG) an" te *$n"en*e intera'

te *$n"en*e intera' in Ge'atie '%$res*en*e Vain Ge'atie '%$res*en*e Va'%e (GCa'i<rat$r (S1) '%e (GCa'i<rat$r (S1) VV aneG)

aneG) CKMB

CKMB e*$nste*$nstit%ti$nit%ti$n s$'ent 1  20 &' s$'ent 1  20 &' ('i%i")

('i%i")

ea"!-t$-%se ; : >it 1 /. s$"i%& a+i"e ea"!-t$-%se ; : >it 1 /. s$"i%& a+i"e

2 2

Se*i*ati$ns #$r te #a*t$r! &aster "ata re%ire" t$ *a'i<rate Se*i*ati$ns #$r te #a*t$r! &aster "ata re%ire" t$ *a'i<rate tete testF

testF

N M. "ata (Master .$t ntr!) r$i"e" in te it= N M. "ata (Master .$t ntr!) r$i"e" in te it= $r

$rN M. <ar *$"es rinte" $n te <$ 'a<e'N M. <ar *$"es rinte" $n te <$ 'a<e' 1 9a*ae Insert r$i"e" in

 Te S9®  _{Te stri}

 Te S9 is *$ate" "%rin r$"%*ti$n >it &$n$*'$na' anti-CK-MB i&&%n$'$<%'ins (&$%se) a* S9 is i"entie" <! te GCKMBG *$"e :n'! re&$e te re%ire" n%&<er $# S9s #r$& te $%* an" *are#%''! resea' te $%* a#ter $enin

 Te stri *$nsists $# 10 >e''s *$ere" >it a 'a<e'e"= #$i' sea' Te 'a<e' *$&rises a <ar *$"e >i* &ain'! in"i*ates te assa! *$"e= it '$t n%&<er an" eirati$n "ate Te #$i' $# te rst >e'' is er#$rate" t$ #a*i'itate te

intr$"%*ti$n $# te sa&'e Te 'ast >e'' $# ea* stri is a *%ette in >i* te ,%$r$&etri* rea"in is

er#$r&e"

 Te >e''s in te *enter se*ti$n $# te stri *$ntain te ari$%s reaents re%ire" #$r te assa!

Des*riti$n $# te Creatine Kinase MB (CKMB) eaent Stri F e''s eaents

1 2

Sa&'e >e''

Sa&'e Di'%entF 300 O' TIS <%?ere" sa'ine (005&$'/'= ; 74) >it r$tein an" *e&i*a' sta<i'i+ers= an" 1 /. s$"i%& a+i"e

3 9re>asF 600 O' TIS <%?ere" sa'ine (005 &$'/'= ; 74) >it r$tein sta<i'i+ers= an" 1 /. s$"i%& a+i"e

4-5 6

asF 600 O' TIS <%?ere" sa'ine (005 &$'/'= ; 74) >it "eterent an" 1 /. s$"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 $satase >it 1 /. s$"i%& a+i"e

7- P

asF 600 O' TIS <%?ere" sa'ine (005 &$'/'= ; 74) >it "eterent an" 1 /. s$"i%& a+i"e &t! >e''

10 ea"in C%ette >it S%<strateF 300 O' 4-Met!'%&<e''i#er!' $sate (06 &&$'/')= Dietan$'a&ine (DAQ) (062 &$'/'= $r 66R= ; P2) ; P2 1 /. (300 O.) s$"i%& a+i"e

Q Sina' $r"F DA

;a+ar" state&ent

;31 F Ca%ses seri$%s e!e "a&ae 9re*a%ti$nar! state&ent

920 Fear r$te*tie '$es/r$te*tie *'$tin/e!e r$te*ti$n/#a*e r$te*ti$n

9305  9351  933F I I SF inse *a%ti$%s'! >it >ater #$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" $<sere r$%tine <i$sa#et! re*a%ti$ns Dis$se $# a'' %se" *$&$nents an" $ter *$nta&inate" &ateria's <!  9iette >it "is$sa<'e tis >i* >i'' "isense 3 &' an"

250 O'

 9$>"er'ess "is$sa<'e '$es

 $r $ter se*i* &ateria's= 'ease re#er t$ te Instr%&ent :erat$rEs Man%a'

a**eta<'e r$*e"%res #$r $tentia''! <i$a+ar"$%s %&an <'$$" r$"%*ts

N Tis it *$ntains r$"%*ts $# ani&a' $riin Certie" n$>'e"e $# te $riin an"/$r sanitar! state $# te ani&a's "$es n$t t$ta''! %arantee te a<sen*e $#   Instr%&ent $# te VIDAS #a&i'!

trans&issi<'e re*$&&en"e"

$tentia''! in#e*ti$%s an" an"'e" $<serin te %s%a' sa#et! re*a%ti$ns ("$ n$t inest $r ina'e)

N D$ n$t &i reaents $r "is$sa<'es #r$& "i?erent '$ts N 9$>"er'ess '$es are re*$&&en"e" as $>"er as

<een re$rte" as a *a%se $# #a'se res%'ts in s$&e en+!&e i&&%n$assa!s(5)

N Kit reaents *$ntain s$"i%& a+i"e >i* *an rea*t >it 'ea" $r *$er '%&<in t$ #$r& e'$sie &eta' a+i"es I# an! 'i%i" *$ntainin s$"i%& a+i"e is "is$se" $# in te '%&<in s!ste&= "rains s$%'" <e ,%se" >it >ater t$ a$i" <%i'"-%

at$eni* aents

r$"%*ts <e treate" as It is tere#$re

AIS AD 9CATI:S _{tat tese}

$r in itr$ "ian$sti* %se $n'! $r r$#essi$na' %se $n'!

N Tis it *$ntains r$"%*ts $# %&an $riin $ n$>n ana'!sis &et$" *an t$ta''! %arantee te a<sen*e $# trans&issi<'e at$eni* aents It is tere#$re re*$&&en"e" tat tese r$"%*ts <e treate" as $tentia''! in#e*ti$%s an"

re*a%ti$ns

an"'e" (see $<serin te %s%a' sa#et!

.a<$rat$r! <i$sa#et! &an%a' - ;: - enea - 'atest e"iti$n)

N Te rea"in *%ette >it s%<strate (>e'' 10) *$ntains an irritant aent (66R "ietan$'a&ine) e#er t$ te a+ar" state&ents G;G an" te re*a%ti$nar! state&ents G9G a<$e

N Si''s s$%'" <e >ie" % t$r$%'! a#ter treat&ent >it 'i%i" "eterent an" a s$'%ti$n $# $%se$'" <'ea* *$ntainin at 'east 05 R s$"i%& !$*'$rite t$ ina*tiate in#e*ti$%s aents See te :erat$rUs Man%a' #$r *'eanin si''s $n $r in te Instr%&ent D$ n$t 'a*e s$'%ti$ns *$ntainin <'ea* in te a%t$*'ae

Assa! 9r$*e"%re

1 e&$e ne*essar! *$&$nents #r$& te it an" ret%rn a'' %n%se" *$&$nents t$ st$rae at 2-JC 2 se $ne GCKMBG stri an" $ne GCKMBG S9 #$r ea*

sa&'e= *$ntr$' $r *a'i<rat$r t$ <e teste" Mae s%re te st$rae $%* as <een *are#%''! resea'e" a#ter te re%ire" S9s ae <een re&$e"

3 Te test is i"entie" <! te GCKMBG *$"e $n te instr%&ent Te *a'i<rat$r &%st <e i"entie" <! GS1G= an" teste" in "%'i*ate I# te *$ntr$' is t$ <e teste"= it s$%'" <e i"entie" <! GC1G

N Te instr%&ent s$%'" <e r$%tine'! *'eane" an" "e*$nta&inate" See te :erat$rUs Man%a' #$r te

ar$riate r$*e"%res 4 I# nee"e"= 'a<e' te GCKMBG eaent Stris >it te ar$riate sa&'e i"enti*ati$n n%&<ers

ST:A AD ;AD.I _{5 Mi te *a'i<rat$r= *$ntr$'s= an" sa&'es %sin a} $rte- t!e &ier (#$r ser%& $r 'as&a searate" #r$& te e''et)

 St$re te VIDAS Creatine Kinase MB (CKMB) it at 2-JC D$ n$t #ree+e te it

 D$ n$t #ree+e reaents= >it te e*eti$n $#  *a'i<rat$rs an" *$ntr$'s a#ter re*$nstit%ti$n

 et%rn %n%se" *$&$nents t$ 2-JC D$ n$t 'eae it *$&$nents $n 'a<$rat$r! <en* #$r eten"e" eri$"s $# ti&e

6 $r tis test= te *a'i<rat$r= *$ntr$'= an" sa&'e test $rti$n is 250 O'

®

7 Insert te GCKMBG eaent Stris an" S9 s int$ te ar$riate $siti$n $n te instr%&ent Ce* t$ &ae s%re te *$'$r 'a<e's >it te assa! *$"e $n te S9s an" te eaent Stris &at*

 Te CKMB S9 s are r$i"e" in a resea'a<'e $%*

®

e&$e $n'! te re%ire" n%&<er $# S9s= *'$sin te $%* *$&'ete'! a#ter $enin

 I# st$re" a**$r"in t$ te re*$&&en"e" *$n"iti$ns= a''

*$&$nents are sta<'e %nti' te eirati$n "ate in"i*ate" $n te 'a<e' e#er t$ te it *$&$siti$n ta<'e #$r se*ia' st$rae *$n"iti$ns

 Initiate te assa! r$*essin as "ire*te" in te :erat$rEs Man%a' A'' te assa! stes are er#$r&e" a%t$&ati*a''! <! te instr%&ent

P e*'$se te ia's an" ret%rn te& t$ te re%ire" te&erat%re a#ter iettin

10 Te assa! >i'' <e *$&'ete" >itin ar$i&ate'! 35 &in%tes A#ter te assa! is *$&'ete"= re&$e te S9s an" stris #r$& te instr%&ent

S9CIM C:..CTI: AD 99AATI:

A**eta<'e se*i&ens in*'%"e ser%& $r 'as&a (>it earin $r DTA anti*$a%'ant) Te %se $# eat-ina*tiate" sera as n$t <een esta<'ise" #$r tis test - "$ n$t eat sera Sa&'es *an <e st$re" at 2-JC in st$ere" t%<es #$r % t$ 2 "a!s I# '$ner st$rae is re%ire"= #ree+e te sera $r 'as&a at -25 L 6JC #$r % t$ e &$nts A$i" reeate" *!*'es $# #ree+in an" ta>in I# ne*essar!= *'ari#! sa&'es <! *entri#%ati$n

11 Dis$se $# te %se" S9s an" stris int$ an ar$riate re*iient

A.IT C:T:.

A *$ntr$' is in*'%"e" in ea* VIDAS Creatine Kinase MB (CKMB) it

 Tis *$ntr$' &%st <e er#$r&e" i&&e"iate'! a#ter $enin a ne> it t$ *e* tat reaent er#$r&an*e as n$t <een a'tere" a* *a'i<rati$n &%st a's$ <e *e*e" %sin tis *$ntr$' Te instr%&ent >i'' $n'! <e a<'e t$ *e* te *$ntr$' a'%e i# it is i"entie" <! C1

ISTCTI:S : S

$r *$&'ete instr%*ti$ns= see te serEs Man%a' ea"in Master '$t "ata

es%'ts *ann$t <e a'i"ate" i# te *$ntr$' a'%e "eiates #r$& te ee*te" a'%es

Be#$re ea* ne> '$t $# reaents is %se"= enter te se*i*ati$ns ($r #a*t$r! &aster "ata) int$ te

instr%&ent

%sin te &aster '$t entr! (M.) "ata $te I# tis $erati$n is n$t er#$r&e" <e#$re initiatin te tests= te instr%&ent >i'' n$t <e a<'e t$ rint res%'ts $teF te &aster '$t "ata nee" $n'! <e entere" $n*e #$r ea* '$t

It is te res$nsi<i'it! $# te %ser t$ er#$r& %a'it!

C$ntr$' in a**$r"an*e >it an! '$*a' a'i*a<'e re%'ati$ns

It

a%t$&ati*a''! "een"in $n te instr%&ent (re#er t$ te

is $ssi<'e t$ enter M. "ata &an%a''! $r _{S.TS AD IT9TATI:}

 T>$ instr%&ent rea"ins #$r ,%$res*en*e in te eaent StriUs rea"in *%ette are taen #$r ea* se*i&en teste" Te rst rea"in is a <a*r$%n" rea"in $# te *%ette an" s%<strate <e#$re te S9 is intr$"%*e" int$ te s%<strate Te se*$n" rea"in is taen a#ter te s%<strate as <een e$se" t$ te en+!&e *$n@%ate re&ainin $n te interi$r $# te S9 Te <a*r$%n" rea"in is s%<tra*te" #r$& te na' rea"in t$ ie a e'atie '%$res*en*e Va'%e (V) #$r te test res%'t

 Te Creatine Kinase MB *$n*entrati$ns are eresse" in n/&'

serEs Man%a') Ca'i<rati$n

Ca'i<rati$n= %sin te *a'i<rat$r r$i"e" in te it= &%st

<e er#$r&e" ea* ti&e a ne> '$t $# reaents is $ene"= a#ter te &aster '$t "ata ae <een entere"

Ca'i<rati$n

s$%'" ten <e er#$r&e" eer! 14 "a!s Tis $erati$n r$i"es instr%&ent-se*i**a'i<rati$n *%res an"

*$&ensates #$r $ssi<'e &in$r ariati$ns in assa! sina' tr$%$%t te se'#-'i#e $# te it

 Te *a'i<rat$r= i"entie" <! S1= &%st <e teste" in "%'i*ate (see te :erat$r Man%a') Te *a'i<rat$r a'%e &%st <e >itin te set V Ge'atie '%$res*en*e Va'%eG

 Te rane $# res%'ts #$r te VIDAS®Creatine Kinase MB

(CKMB) assa! is 0 - 300 n/&' Sa&'es >it res%'ts 'ess tan 0 n/&' are re$rte" as G  0 n/&'G

Dete*ti$n 'i&it

 Te "ete*ti$n 'i&it (assa! sensitiit!) is "ene" as te '$>est *$n*entrati$n tat *an <e "istin%ise" #r$& +er$ >it P5 R r$<a<i'it! Te "ete*ti$n 'i&it #$r te VIDAS Creatine Kinase MB (CKMB) Assa! is 0 n/&'

Sa&'es >it res%'ts reater tan 300 n/&' &%st <e "i'%te" in CKMB neatie (0 n/&.) sera s$ res%'ts >i'' <e >itin assa! rane (a 1/4 "i'%ti$n is re*$&&en"e" F 1 $'%&e $# sa&'e an" 3 $'%&es $# CKMB neatie sera) I# te "i'%ti$n #a*t$r as n$t <een entere" >en te

ana'!sis as <een re%este" (see :erat$rEs Man%a')= &%'ti'! te res%'t <! te "i'%ti$n #a*t$r t$ $<tain te

Creatine Kinase MB sa&'e *$n*entrati$n

;$$ e?e*t

 Te ;$$ e?e*t >as ea'%ate" %sin Creatine Kinase MB s$'%ti$ns >$se rese*tie *$n*entrati$ns >ere #r$& 06 t$ 10=000 n/&' A rea*ti$n *%re 'atea% >as $<sere" at *$n*entrati$ns reater tan 2500 n/&'= <%t n$

$$

e?e*t >as seen % t$ 10=000 n/&' A re$rt is rinte" >i* re*$r"s F

 te t!e $# test er#$r&e"=

 te sa&'e i"enti*ati$n= ;::K CT : CKMB

 te "ate an" ti&e=

 te '$t n%&<er an" te eirati$n "ate $# te reaent it

<ein %se"=

ea* sa&'eUs V an" CKMB *$n*entrati$n

9:MAC DATA _V

I&&%n$'$i*a' Se*i*it!

I&&%n$'$i*a' inter#eren*e >as teste" <! a""in 10 % /&' $# CKBB an" CKMM t$ t>$ sa&'es *$ntainin 0P n/&' an" 1P2 n/&' $# Creatine Kinase MB rese*tie'!

 Teste" *$&$%n" Cr$ss-rea*tiit! er*entae $r&a' ane $#  Sa&'e eatie Ser%& 0P 053 0-164 ---W Ca'i<rati$n ane eatie Ser%& an"

CKBB n/&'

SCI99S

('$t 607264=*atC1124) eatie Ser%& an"

CKMM 0P3 SCI99S ('$t 755264=*atC1324) 9$sitie Ser%& 1P2 1P37 116-1P6 9$sitie Ser%& an"

CKBB SCI99S

('$t 607264=*at1124) 9$sitie Ser%& an"

CKMM

13 SCI99S ('$t

755264=*atC1324)

$ inter#eren*e >as $<sere" >it te *reatine inase is$#$r&s BB an" MM

9re*isi$n

Intra-assa! rer$"%*i<i'it!

Fie sa&'es >ere 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 62 11P4 34 361 43 P47P 33 26536 34 R CV

Inter-assa! rer$"%*i<i'it! $n te sa&e instr%&ent F

ie sa&'es >ere teste" in 23 r%ns $n te sa&e instr%&ent $er an ->ee eri$" (re*a'i<rati$n >as er#$r&e" eer! 14 "a!s as "es*ri<e" in te :erat$rUs Man%a')

Sa&'e 1 2 3 4 5 Mean *$n*entrati$n (n/&') 3P0 72 124P 50 3P3 40 P7 45 21P0 55 R CV

Inter-instr%&ent an" inter-assa! rer$"%*i<i'it!

ie sa&'es >ere 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/&') 41 167 1257 45 346 47 P0 37 2754 57 R CV A**%ra*!

9ara''e'is& (Di'%ti$n tests)F

 Tree sa&'es >ere "i'%te" in *reatine inase MB neatie sera an" teste" in sin'et in 3 r%ns e*te" &ean *$n*entrati$n (n/&') Meas%re" &ean *$n*entrati$n (n/&') Mean re*$er! er*entae Sa&'e Di'%ti$n #a*t$r

1/1 1/2 2635 1341 670 3354 1677 3P 2635 130P4 6535 31 153 34 100 P 1 1/4 P7 1/ P5 1/16 1/32 1/1 P4 PP 2474 14237 711P 355P 170 P0 2474 141P1 7467 3505 173 P37 100 100 105 P 1/2 2 1/4 1/ 1/16 1/32 1/1 105 105 100 100 100 100 103 114 P35 467P 2340 1170 55 P35 464 2350 1166 605 1/2 3 1/4 1/ 1/16 1/32 _{2P2 332}

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$>n <e'$>

e*te" &ean *$n*entrati$n (n/&') Meas%re" &ean *$n*entrati$n (n/&') A&$%nt sie" (n/&') Mean re*$er! er*entae Sa&'e 0 041 24 041 21P 100  207 332 435 1046 511 0 1 373 376 101 4 476 402 107 5222 1104 1311 1435 153 2150 624 331 77 1 44P1 1104 130P 12P1 15P3 21P4 5651 331 6 100 100 P0 207 332 435 1046 511 0 2 104 102 P0 100 102 104 104 P6 207 332 435 1046 511 53 54P 3 662 6P0 765 7P2 1377 5511 1321 5070 P2

I.C : S9CIM C:..CTI:

B'$$" sa&'es >ere *$''e*te" #r$& t>ent! eit atients $r ea* atient= 4 se*i&ens >ere *$''e*te" at te sa&e ti&eF in a "r! 'ass t%<e >it a '!*er$'e" *aH in a t%<e >it searatin e'H in a si'i*$ni+e" t%<eH an" in a n$n si'i*$ni+e" t%<e B'$$" sa&'es >ere a's$ *$''e*te" #r$& eiteen atients an" *$''e*te" in a "r! 'ass t%<e >it a '!*er$'e" *aH in a DTA t%<eH an" in a earini+e" t%<e a* sa&'e *$''e*te" >as teste" in "%'i*ate an" sera #r$& te sa&e "$n$r >ere teste" in te sa&e r%n Te "r! 'ass t%<e >it te '!*er$'e" *a >as te re#eren*e t$ >i* te $ter t%<es >ere *$&are"

C$''e*ti$n t%<e  T%<e >it searatin e'

Si'i*$ne t%<e

%ati$n $# te 'ine 101   -030 102   -007 112   -044 103   0076 0PP   0057 C$rre'ati$n *$eX*ient 0PP 0PP 0PP 0PP 0PP $n si'i*$ni+e" t%<e

 T%<e >it DTA

 T%<e >it earin ('iti%&) ITC STDIS

;earin

 T>$ $$'s $# %&an sera >ere sie" >it in*reasin %antities $# earin

A&$%nt $# earin sie" (/&')

0 05 4 5 50 50 CKMB (n/&') 9$$' 1 9$$' 2 4 51 P4P P35 P57 P1

DTA

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

A&$%nt $# DTA sie" (&/&')

0 1 5 10 4 CKMB (n/&') 9$$' 1 9$$' 2 4 51 P14 50 P15 P35 P55 ;e&$'$<in

 T>$ $$'s $# %&an sera >ere sie" >it in*reasin %antities $# e&$'$<in

A&$%nt $# e&$'$<in sie" (O&$'/')

0 125 51 25 47 50 44 100 3P 500 37 1000 54 CKMB (n/&') 9$$' 1 9$$' 2 47 P26 P57 P50 P5P P40 P1 P15  T%r<i"it!

 T>$ $$'s $# %&an sera >ere sie" >it in*reasin %antities $# a 'ii" s$'%ti$n

A&$%nt $# tri'!*eri"es sie" (/')

0 025 05 55 10 20 54 CKMB (n/&') 9$$' 1 9$$' 2 57 52 5P 6P3 713 716 73 723

Aearan*e C'ear :a'es*ent T%r<i"

Bi'ir%<in

 T>$ $$'s $# %&an sera >ere sie" >it in*reasin %antities $# <i'ir%<in

A&$%nt $# <i'ir%<in sie" (O&$'/')

0 12P 5P 22 64 36 61 100 70 1500 62 1P25 60 CKMB (n/&') 9$$' 1 9$$' 2 64 50 04 05 72P 776 05 02

A't$% inter#eren*e 'ine" t$ te resen*e $# e&$'$<in= <i'ir%<in $r t$ t%r<i"it! as n$t <een $<sere"= %sin e&$'!+e"= i*teri* $r 'ie&i* sa&'es is n$t re*$&&en"e" I# $ssi<'e= *$''e*t a ne> se*i&en

89CTD VA.S

 Te PPR *$n"en*e 'i&it #$r te n$r&a' rane $# CKMB teste" in 6 ea't! in"ii"%a's >as "eter&ine" t$ <e 6 n/&' It is re*$&&en"e" tat ea* 'a<$rat$r! esta<'is its $>n ee*te" a'%es $n a >e''-"ene" $%'ati$n

C:.ATI:

®

:ne %n"re" seent! e sa&'es >ere teste" >itin te rane $# 0 - 300 n/&' %sin te VIDAS *reatine inase MB (CKMB) Assa! an" a *$&&er*ia''! aai'a<'e IA Sa&'es >ere $<taine" #r$& ea't! <'$$" "$n$rs an" $sita'i+e" atients #r$& interna' &e"i*ine an" *ar"ia*-as*%'ar "iisi$ns A s%&&ar! $# te res%'ts is s$>n <e'$>

Y $# Sa&'es 175 S'$e 03 Inter*et -0656 C$rre'ati$n *$eX*ient 0P7

AST DIS9:SA. ID8 : SMB:.S S!&<$'

Dis$se $# %se" $r %n%se" reaents as >e'' as an! $ter *$nta&inate" "is$sa<'e &ateria's #$''$>in r$*e"%res #$r in#e*ti$%s $r $tentia''! in#e*ti$%s r$"%*ts

It is te res$nsi<i'it! $# ea* 'a<$rat$r! t$ an"'e >aste

an" eZ%ents r$"%*e" a**$r"in t$ teir nat%re an"

"eree $# a+ar"$%sness an" t$ treat an" "is$se $# 

Meanin Cata'$ n%&<er

In Vitr$ Dian$sti* Me"i*a' Dei*e te& ($r ae te& treate" an" "is$se" $#) in

a**$r"an*e >it an! a'i*a<'e re%'ati$ns Man%#a*t%rer .ITAT CS

1 .an"t= = ; Vai"!a= S 9$rter= D Diet+ier= [ .a"ens$n 1PP I&&%n$aXnit! 9%ri*ati$n $# Creatine Kinase-MB #r$& ;%&an= D$= an" a<<it ;eart >it se $# a M$n$*'$na' Anti<$"! Se*i* #$r CK-MB C'ini*a' Ce&istr! $' 35 n$ 6 P5-PP

 Te&erat%re 'i&it se <! "ate

2

3

een$= I= M Man*$n 1PP3 Interet A*t%e' "e 'a CK-MB

"ans 'e Dian$sti*"e .Ein#a*t%s"% M!$*ar"e .!$n _{Bat* *$"e} 9ar&a*e%ti%e 'seier= 9aris 3-P0

erar"t= = . .@%n"a'= 1PP3 ati$na' Dian$sti* _{C$ns%'t Instr%*ti$ns #$r se} Strate! in Dian$sis $# Is*e&i* M!$*ar"ia' In@%r!

S-tr$$nin an" S-CKMB (&ass) Ti&es Series sin In"ii"%a' Base'ine Va'%es S*an" [ C'in .a< Inest 53(S%' 215) 47-5P C$ntains s%X*ient #$r nW tests Date $# &an%#a*t%re 4 5

Ba!ana= V= S C$$e=  .e%n=  [a<'$ns!= A ;en"ers$n 1PP3 Dian$sti* a'%ati$n $# Creatine Kinase-2 Mass an" Creatine Kinase-3 an" -Kinase-2 Is$#$r& ati$s in ar'! Dian$sis $# A*%te M!$*ar"ia' In#ar*ti$n C'ini*a' Ce&istr!=

4-4P5 AAT

<i$M\rie%= In* "is*'ai&s a'' >arranties= eress $r .a&e= AS= ;[ 9eiterse-Br%ins= an" [C teran

i&'ie"= in*'%"in an! i&'ie" >arranties $#   A isser"ere 1P earin '$es as *a%se $# #a'se

MC;ATABI.IT AD ITSS : neatie ;IV tests .an*et ii 1140-1144

9ATIC.A S <i$M\rie% sa'' n$t <e 'ia<'e #$r an! in*i"enta' $r *$nse%entia' "a&aes I : VT S;A.. BI:MI8ES .IABI.IT T: CST:M D A C.AIM 8CD A D : T; AM:T 9AID T: BI:MI8 : T; 9:DCT : SVIC ;IC; IS T; SB[CT : T; C.AIM

VISI: ;IST:

Cane t!e *ate$ries F

/A $t a'i*a<'e (irst %<'i*ati$n)

C$rre*ti$n C$rre*ti$n $# "$*%&entati$n an$&a'ies  Te*ni*a' *ane

A"&inistratie

A""iti$n= reisi$n an"/$r re&$a' $# in#$r&ati$n re'ate" t$ te r$"%*t

I&'e&entati$n $# n$n-te*ni*a' *anes n$ti*ea<'e t$ te % ser

$teF Min$r t!$rai*a'= ra&&ar= an" #$r&attin *anes are n$t in*'%"e" in te reisi$n ist$r!

e'ease "ate

9art %&<er Cane T!e Cane S%&&ar! ID8 : SMB:.S VISI: ;IST: A"&inistratie  Te*ni*a' 2015/01 2015/06 13765C 13765D

KIT C:M9:SITI: (30 tests) AIS AD 9CATI:S KIT C:M9:SITI: (30 tests) ISTCTI:S : S  Te*ni*a'

BI:MI8= te <'%e '$$= S9 an" VIDAS are %se"= en"in an"/$r reistere" tra"e&ars <e'$nin t$ <i$M\rie% $r $ne $# its s%<si"iaries= $r $ne $# its *$&anies

An! $ter na&e $r tra"e&ar is te r$ert! $# its rese*tie $>ner

<i$M\rie% SA 376 Ce&in "e 'E:r&e

6P20 Mar*!-'Ut$i'e  ran*e 673 620 3PP CS .: Distri<%te" <! <i$M\rie%= In* 100 $"$'e Street  Te' 33 (0)4 7 7 20 00