CREATININE (ENZYMATIC)
Package incon insvuctens must be careful oowed. Rly ot
assay ruts cannot be guaratood f here are any devin from the
insrstons inthis package Insert.
end Highlahted Changes: Revised Mazch 2047,
INTENDED USE
‘The MULTIGENT Creatine (Enzyte) asay is intend for tho
{quartatve ceterination of creatinine n human sour psi, and
{rine using the ARCHITECT oSysiems.
‘SUMMARY AND EXPLANATION OF TEST
Crean ie elimirted rom loo by glomerular raion. Reduces
‘eral uncon results nan roreased serum creatinine concern,
Measurement of serum ceaiinef used Wo shagnoss snd manor cto
and evanc ronal dscace, esto lama irate rat (GF), or
‘asonos the caus of rena dls patents, Urine ceainne anes
'S used fo calculate cretrine ciearanes contem completeness ot
‘2ichow calections, or sen 28a rooronce quan for ether seals,
{uh a in ealouton of tha abumin/eretinn ate”
PRINCIPLES OF PROCEDURE
Creatine inthe sample is hyve by creannase to crest.
(Geain num hyiyzoe by erate to exooeno and re.
Sareosine tam ti reacen i vczed by sarcoane axdane to acing
and errata, win be concomtae roditon of hyeagen
Derxida® The erogen porno reacts wih 4-aminoatpyia and
SPT ino prosonco of porodace toyed aunonomne ye.
Tha resulting change abexrbance at S48 nm fe sroparional tthe
create cancortaton in ta sala. This enzymatic met =
Smnstve and patie for cathe an eno toned by enaogenovs
‘subsanoes, sch as ketoacia, copalosprna, and bib hat
ier wih tho dae thos
ESPMT ~ Nett euosopyim foie
Methodology: Exzyate
REAGENTS:
Reagent kit
MULTIGENT Croatvne (Gray) is cupped ae Lui red 0-u8e,
‘Mo-agert hit hich soa:
Bans
TH] exe mt
fe) sxam
Esimctod ets por Kt 760"
aes
H) oxs0m
[fa] oxseme
Etat tess pert: 4.820"
* Calculation basod onthe minenum reagent vue po kt.
“Resse agesiens__—__carsentaon
“Tal Gods oar TTS] "eal
Creatnaso 3 re ku
Sercodine oxiase ze KuIL
Cataize > 200 U/L
Spur 47 moot
Good's Baer RTS) “00m
restninase 300 U/L
Perowdaee 220k
demeoertiprine 295 mmol.
Noneacts Ingrosirts: [RT] soniinsdetergrt (<1) and preconatve
[Bal cntsine detergent (= 0.9%) and serum azo (= 0%).
REAGENT HANDLING AND STORAGE
Reagent Haring
Ready or use
Feady or vo.
+ Remove af bubbles if aosent in the reagent carpe, wh a
aw apoleatestek. Aten, Mow the reagent a the
Sopropro storage tamparatie to alow te bbls to Senate
‘Tominimze wiume depieten do not use a vanstr patie to romove
the bes
{CRUTION: Reagent wbbiee may terre wth proper detacton of
‘reagent level nthe catidg, causing Inuit reagent aspiration
that cou impact ess
en
CREATININE (ENZYMATIC)
(EF) 8L.24-31 and 8124-41
G10667/RO8
B8L240
ARCHITECT
Reagent Storage
“+ Unopened reagores ar stale ur the expan date when stored
gt2msc.
+ Reagent salty e 80 days i he reagent is wncapped and onboard
Indications of Deterioration
“The reagent mus bo clear. istablty or cetroraton shouts bo
Suspoctd thre are vb ogre eakago fr, mised growth
orf eabraion doesnot mee he appre package insert ardor
ARCHITECT System Operations Manual ctr,
NOTE: A elaht yefew coloration wl not fect reagent pedormence,
WARNINGS AND PRECAUTIONS
Precautions for Users
+ Forin vio Dagnotc Uso.
+ Do nat te compenente Boyan ho eiaton cate
+ Do not mic mata rom eer tt numbers
+ CAUTION: Tis posuct ques the handing of huran specinens.
Tis vecommardee tat all huran-souess metals Be ooaiered
potervalyiisosous and handed aeoorarce wih the OSHA
‘Standard on Bloodbome Patnogans Biosafety Love 2° ot other
approprato best praca shouldbe Utd fr ator tht
omain a ate suspoctos of contaring infectious agai,
Tie flow sings and pecans set Bz}
EUH0G2 Cort: wth ects Ibomate very te gas
SOT “Ospose of costenisfoonainar i acoa'dance wih lec
+ samy Das Soot ae vane awe toendogrestesn
‘ortact your eal represent
+ Fora coal dsousseon of asely reessons Ura Stor
‘Berio reo ANGHTECT Sytem Opemtons Manu
‘SPECIMEN COLLECTION AND HANDLING
Suitable Specimens
Serum: Use eran cofectod by standard venipuncture teciaues
Ino plastic ubes wih or witout gal bares. Enaare complete
‘lot emaon ns takan place pare sotiugation Cone
‘according to tse eanlockrers hauctone te enaure ope
Separation of sou om bod cls Glass tubes were ht Lee.
Some specimane, especial hae om pation eeshing
rtcoggulart or irombole thercy may tae longer o comalto
thar eating processes. ln cts may subeeuerty form m tees
‘sera and fw cols coud cause eroneous tes fei
+ Plasma: Use plana colocted by standard venipunture echnauee
Ino plate tubo, Te scossab artecagulats are ium hase
(nto thou gl bares and sium hapa, EDTA erat
recommended. An ial study sowed decreased sits. Ensure
‘centupaion is adequato to remove pets. Corlugeacoordng
{fo tubo manulzctur'sareton to enue proper seperation ot
Blusra om Biood cats. Glas ee wera hot tes
+ Uri: Cost untied! specimens er spesemsns tines over ntrals
‘hore han 4 hours wih na poser
+ Daur Une: May be ootooed win preseratve. The peered
‘resonatvee aro bore ae and hyerosnion sea Reference “anges
[ro prowded fo 24chour excretion
NOTE: Une specimens mast be inspect fe parteusoe: presen,