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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,

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