(Snibe) ALB Albumin Assay Intonded Use The Snibe Dissays® ALB reagents intended fr the nwo dict quanits- ve determination of atu in human serum, (Bcc) Package REF Cente Suspering Anahar "os0200eL R:Sx60mL C7205 802200 ‘ek 8000 Bioesays C8 ‘osoacoss Be 60 mt, Emil ‘AS-2450 AS-24500 a A Bossays 240 1905020008 R230 mL oe Assay Principle ‘Serum albumin binds selocvely wth bromresol green to produce a coe ‘red complex. The absortance ofthe complex a 630 rm See proper {ional ote albumin concentration in he samp. ‘ a seen (ETE 11011 pee - i basco rr Seater Biossays® Clinical Chemistry cE ‘Specimen Collection and Storage + Collect ood aseptically foloxing the universal precautions for venipuncture with standard sampling tubes. Separate serum as soon as possible * Do not use specimens with bacterial contamination or heat inaction * Ensure comsiete ct tmatin has taken place ports cantitsgefen Some ‘specimens, especialy those tom patents feosieg entonogunt cr ‘trombayc herapy may exit neased cating ire * For opts! results, specimens must be free offen, red Dood cells or ‘ther partouste eubstance, * Avo recesing feezsinaw yses, The gpasinen can be fozen end awed ony once. Soecmons rust be mas toroughly ster thang. * Specimens may be stored up to 30 ys at 28°C and up to 3 mont at 20°C orca. * Specimens wih concentaters exceeding the upper fit of messurng ‘ange canbe cities wth salina, Tost Procedure {8C1200, Bcz200, stun oan: ‘Reagents re provided ready to. ‘Materials Required But Not Provided R value Gt] Eo ‘Mic thoroughly, cubated Yor min, And then read te absorbance at primarisecondary waveiengt (680/700 ‘Anaieis Mato 7 point en ‘Altaloe Wises REF. sa058R0007 eacion Oreoton insease ‘esd Wash REF: ts0ses0002 Biossays 240 Plus, iossays 240) "Test procedure Htegent REF: r30seo0009 a ; lease order above aacessores fom Shenzhen New iauaias Samedcal | sonal vals Enginesing Co, Lid (SNIBE) or cur authorized represeriatves, value i) 23 Putte war, Sample cup. * Gitical emisty Calbraton Senn Leve 2 (REF CAL2850) of Rendox Laborsores is recommended to use for ealbaten * Chemisty Pemtum Pls Level 2 (REF HN1520) and Chomisty Prenium us Level 3 (REF HE1S32) of Randox Lapras are recommenced © se forty cont Precautions + Forin vir csgnostic use, * Before tet, please read the efocive version of user manual and ‘make sue al procedures ar clear. + Donet use the eagers beyond tha axpeaton det, + Do net mixeageres tom aitecont it numbers * Avoid Ingestion and conact wih skin of mucous membranes, Pease wear clean gloves when operating wih a reagent kit or samples which must be disposed atin 2 safe way * 108 recommensed that ail numan ane animal sourced materals (cal Drators, quay conte and al specimens) shouldbe conicered pote". Sally ivectous and handed in accordance wih the curent regulations and guidelines of juiscicions! agency of lboratory as wel 9 De responding sate equations, Reagent Storage and Stability * Unopened stored at 25°C unt the expation date + Opened: stress 29°C fer 28 days + Ontoaré sable 7 days. + Donat teezs Koop away fom sunt S18 ALBLFU-en-CU, vo, 2022-08, ‘Mik teroughty, cubated for? an. And Wn read the ebsotbance al Drimaryfsecondary wavstenat (630 nm 7G6 ‘Anaiysis Method 1 point en easton Director Trerease: Biossays 08, Biouri Ox (Yestprecedure pe (epecion, TESST oF a onto) volume (ut) vaume (ty ia ‘Wx heroughy, nebted fr 2 rin. And ten jead the absorbance a imarylsecandary wavelength (620 nml700 rn) ‘Analysis Method “point end ‘Reaction Deaton Tnereaee (93.2460, AS-2450NE Test procedure Sarsie der a= ‘Same epociran salbaar ar a6 entra lume (ut) vole il) a ‘Moc thoroughly, neubaied or min, And then read te absorbance a ‘rimanisecondary wavelength (630 nmG34 Anayss Method Tpaitend Reaction Becton Tnereaso Calibration ‘A two-point rear calbration is used for ALB. Catron is stable for ep- poximatay 28 day Recaitraton is recommenced at any time fone of the ‘lowing events+ The Lot number efreagent changes. 1 Preventative maltenance is perfomed or a criesl component re- placed + The resus of quality conta fa outside accopable ranges and a caw a of cont does not rcs the problem ‘Quality Controt + tis recomended tat at least two levels of quay conte, nara! and ‘atnama, bern daly. Qualty certs shou eso be nn atthe conon at newealeaten, new at fragerts, and stir peveriave meinerence is Derlomedor a crical someanents repsced +The cont rtevals and mis should be aestec to each lboratan/s ‘vival quirement + Coch iboreton anu! estebshcoective measures tobe taken faves fallout ne catnes iis. + Folow he applicable overmertraguatons and cca guidelines for quay conte. Results ‘ibe systems automaticaly esleulate the analyte concentration of each samole otxo.teplt Expected Values. ‘Act 96-55 gt (2.8°-97.5" percents) “The expected range for exit vas obaind from 212 apparenty healthy edicts in China between the ages of 2 and 69 year. IRis strongly recommended that each abortcry establish ts oan range of ferpected vaies, since dforences est between instruments, ebortaris, ‘and local poputtons. Limitations For éagnose urpoees, the results should alvays be assess in cofunc= tion wll he patent's mecieal stay, cineal examination and ober ciag- neste posesures. Performance Characteristics ‘All Pesormanes Charateraice were detemined at Srive Co, Lid using ‘Automate iccnonisty Analyzer. Limit of Detection (LoD) ‘The LoD for ALB i to Measuring Range +209 ‘Yeloes below the loner init of measuring range re resorted 2s <1 gi. ‘And valiae above the upper Emi of measuring range are reported as 60 on Precision Pression was cetemined ss desebed in the CLS EPE-A2. The folning results were coined unit | steen [_WitinRun | Getween-Run | Total ot | wee [so | eve | so | cv | so | om Seam | aot ase oss | ass | cao | 305 Seum | so.10 [os 018 3 seu [soce [uu [a7 [ose | 120 [120 [300 Serum [aoe2 | 143 | 350 ooo | 143 | sso Pools Recovery “THe recovery in the range of 80%-110%. Ieterarenca “Ths fetoving substances normaly pasent in 2arum produced within #1084 aviation ate Usted concorvatons: * Testi at 500 mot. 1+ Asoatic ac at 30 maha. 518 ALBAFLen £0, Vo. 202203 Biossays” Clinical Chemistry + Birbin at 20 mg/d + Hemoglcin at 400 maid References, 4.8 Deparimert of Heath and Human Senices. Biosafety in Mero ‘obgical and Biomedea! Laboratories. HHS Pubieation (CDC), 4h ed \Wesnington, DC: US Government Pritng Ofce, May 1998, Heine M, Hel W, Witold W. Sevag of serum and whol ood samples? [Btocts f tie and temperature on 22 serum analytes. Eur J Gin Chom {iin Biochem 1995; 33.281-8. 3. Dale JC, Prust SK Phiebotomy-a minimalist speroech Mayo Gin Proc 3995) 68 (@):280-55. 4 Sarep Cunacer, Mehmet Koseosty, Aysanur Als, Ast Diican. The ‘act of storage tine ard treez=-tan cies onthe sieily of sum samples. Blostema besos: Cscpls Hrvatskoga Oreve Mecicinskh Bickeriara 2043, 2 (1): 707. Cinical and Laboratory Standarde Istule (CLS). Procedures for the handing and prosaecing of blocs specimens fer common Isborory test; approves guideline, Dooumont HI8.A, Val 99 N*10; 2910 Fauliner AM, LokesHal AM, Whe GW. Evaluation of the Grenier ‘plasma separator bod tube. Ann Cin Biochem 1890; 27:286-7. 7.GLSi, Dething, Estebishing, and Veriying Reference Intervals inthe ‘nice Laborstoy: Approved Guideine-Third Eden. CLSI document Epzeade, Wane PA: Cihal and Laboratory Standards Istiute; — 2008) ‘Symbols Explanations 1¢Tengeuetnt caaione Wa om eae SK Keepamay tom wm [x = Ro easert, Th reere Go theives toy te [ERT] comers ort vo} naa CT] sete | Ce ccm fuoraes econ eo [ne] Salina Soma ‘Biosays® and Dili ar trademarks of Sib. Al ether product names and trademark ar tho property of tel respective cuners. eel “Shenzhen New induces Blowedeal Exgnesring Go, Ld No2, Jnsy East Read, Pieganan District 516122 Shenzhen, PIR China Tet 486.755-2156001 Fax +86-755-28282740 ‘Shanghai Intemational Holding Corp. 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