CREATININE (ENZYMATIC)
Package nso instrucions mus be costly tole, Reb of
assay rsuls cannot be gusrartod thos ae ay deviations Hom the
Instucters mths package rer
ead Hahlted Chonaes; Revised Mich 2017,
INTENDED USE
‘The MULTIGENT Crextnine (Eraynate) asay is intended fr he
‘uantatve determination of sreatnine human serum plasma, and
thin using the ARCHITECT cSyzoms.
‘SUMMARY AND EXPLANATION OF TEST
Creatine i lmnated rom boos By omens fivaon. Recueod
‘ena ureten eeu in an inseased sen crosinine concen,
Massuremor of serum crstne is sed fo diagnose ars monsor note
and chore renal seas, ema gomeuar iraton rate (GF), 0°
{Seeoee tho dats cf orl dalyis patents sno reat anaes
Is used to cacuae creatine deze, confirm completes of
2esnour easton, env ae aceon quay fr ster anaes,
uch et in ealelton of te aburinjcroainno ata"
PRINCIPLES OF PROCEDURE
Grainne inne sence tyes by cease to caine:
{retin stra ye by erat to soni 2 ra
Sacoona nm th wanton ned by sacar oar to ahyohe
‘nd lomgleny, wh te enaaet ston of Sysone
roms Tho open pode reas wth «aminarpyne ad
EGSha ine posonn of porocante told a qunonortine dy.
“hares change in abserbanos st 5 nm proportorl oo
cece cancataaion nthe seme. Ths enact i
Sess and spots or ese anid no fern Oy endogenous
Subsarse such an eau cophaspotna on nha Pak
‘etow ath the ate neo
ESPIT = Neth sory ohicina
‘Beet crete
REAGENTS
Reagent Kit
MALTICENT Creatine (Enamrate pled 25 abu ead.
‘ownage woh eons
Baas
excam.
ante aL
Esra os port 70"
Ban
{] 10x90m.
fe bxsem.
simatd ices por Kt 4.820"
* Caleta is Exsed on te isimar reagent il vue por kt
Faacie rears Careers
TA] Good's stor 7) 25 mol,
Creatinase 212 kuL
Strossine xis eK
Catalase = 200 KUL
SPT. 0.47 mmol
“Ba Good's Sater wT 00 roi
Creatininase 500 KYL
Peroridase 220 KUL
scamncantoyrne 205 mmol,
roast Ingroires: [i coniins detergrt (<1) and presente
[Bel corns etergont (= O58) and sesum azie (<0).
REAGENT HANDLING AND STORAGE
Reagent Handling
[Ba] oasy tor uso.
+ Tl Ready tor use
+ Bemove i bubties poser inthe reegant carnage win @
new sppleator etek. Aternably alow ie reagent stot he
_2propiate storage ianpuau to alow te bblest espa
“oimnimaze vaume dplen, do nol ube Yarstar ppt To rmnove
the bubbies
‘CAUTION: Feaget bubble may nteriere with proper detecion of
feagurt level inno eaispa, causing moult agent sepraton
‘hat cau mpact veut
&
en
(CREATININE (ENZYMATIC)
}8L24-31 and 8124-41
G10667/RO8
B8L240
ARCHITECT
Reagent Storage
* Unopened regents ae stable ut the exaton date when sort
R208.
+ agent Sabiy i 80 dye # he reagontie uncapped ane onboard
Indications of Deterioration
‘The regent must be clos eabily er doerirtien shou be
i theo aro wll sigs of fakage, tural mera growth
fri ealbaion exes nt moot he apropate package Isat anal
[ARCHITECT Syetom Operations Manal teria.
NOTE: sign ytow coloration wl ot tle reapee pavermanoa
WARNINGS AND PRECAUTIONS
Precautions for Users
+ For Vso Diagestic Use
+ De not uso components boyoné tho oxation de
+ Bo net ma area Creme x ruber
+ CAUTION: Te product rqures ie hencng 9 human specimens,
W's resonmendes that al furan soured rte be conscered
potest locious and handles in aczardanoa mh the OSHA
Standard on Sodborre Pathogens“ Basalety Love! 2° oF ober
sppoprat iat pasion’ shoul bo used for materia tha
orn o ate suspected of conaring inectous agents
“Te fofowng warring and proautone apply 2}
Conisne sain 222, oe
EUHOS2 Contact wit ais borates very tx
so? Depa af eomriseomsnr i secodance wt al
po
nn
ee nn
- ESR lees
eg te ct cn pc
‘SPECIMEN COLLECTION AND HANDLING
‘Suitable Specimens
* Serum: Use serum coated by standard venipuncture tecmniques
ino labo tubes wih or witcat gel baer, Enaur corte
ot ormation has taken lace porto cnttgation. Conte
{ccordrg to ube manulacurer's nsructons to ensue pepe”
Seperaton of serum trom bse cas Glas tubes were not tests.
‘Sem specinens, especial tooo om patos recokrg
srtccagurt or ‘erapy may take ergo o completo
‘hake cating procosees Pinte nay seen Som ne
+ Plasma: Use plasma collected by andar veipuncure‘ecbiques|
‘no paste tubes, Te aboostadleartcoaguars are hum hapa
{jo winour gol Bern and Sodium hath, EDTA ena
‘ecormonded. An trl st) showed deroasod este ERG
‘entfugation is adequsto to romove pte. Corauge aooorcing
to lube manutecturr'sfaractone fo ensure proper separation of
‘Siam from boos col Glass tes wero not ee,
+ Wine: Colect untied specimens or specimens timed ovr intra
‘horer han 24 hers wih no pesoraive
+ 2éHour Urine: May be oaootos wih preservative. The prefered
‘resonates oe bore aot and hycrochiorc aed.*Relernce ranges
‘re promod fo 24-hour sxreton.
NTE: Urine epecinons mus bo inepeta fr parfouts. I proce,
Cenrfag the spectron to romovopariculaes prt testing
For ttl ease vue raguvorent, oe othe ASSAY PERAMETERS
‘soot ofthis package eer and Secon 5 of the ARCHITECT System
‘Operations Manual