Cnba Website www.erbamannheim.com : S.G.P.T (€ E IFCG Method, Kinetic INTENDEDUSE ofALT/ plasma. Diagnostic reagenl for quantitative ir) vltro determination GPT (Alanine Aminolransfsrase) in human serum and SToMGE ANo STABILITY Priorto Reconstituton Unopened reagenl vial is stable till the label when stor€d d epiry dale stated on lhe z-a"C. Afler Reconsffution CLINICAL SIGNIFICANCE tesser 6xl6nt in kidnsy,heart, skeletal muscle, pancreas, spteen and ALT/GPT is present in high concentration in tiver and lo a The Gagent is slable for 30 days at 23'c. Discard if lhe reagenl tumsturbidor ifiheabsotuance is lessthan 0 8al340nm againsl lung.lncreas€d levels of ALT/GPT however rs generally a result of liver disease associated wilh some degree of hepatic necrosis such as cirhosis, viral or toxic hepatitas and obslructi\o SPECIMEN COLLECTION Al{D HANDLTNG dice. CharacteristicallyAlT/GPT is genel8lly higher than AST/GPT lJse unheamot).tic serum or ptasma (h€parin, EDTA). lt is recommended to follow NCCLS procedures (or similar in acute Mml or toric hepalitis, wh€r6as for most palients chronic hepalicdisease, ALT/GPTle\els are generally lowerthan standardizsd conditions). Lo$ ot activity: AST/cpT te,/els. Ete\,ated ALT/cpT te\ets ha\e atso been < 10 % within 3 in e{ensile trauma and muscle disease, circulatory failure with < within a|15-25"C 17 a/o shock, hypoia, myocardial infarction and haemolytic disease. Stablllty at least 3 monlhs al -20 'C Dlscard contaminaled specimens. jaunwith found i,ETHODOLOGY lnlernalional Federaliorr of clinical chemislry ( lFcc I - - PR[{CtPt-E L-Alanrne + Pyru\,€le 2-Oxoslularate + NADH ALT : LOH : '"" '+ > Pyruyale + L-Gldamate L-Lactaie + NAD Alanine aminotransferase Lactale dehydrogenase REAGENI COMPOSITION ( when roconstituled as dirsclsd ) REAGENTl:SGPTReag€nt 500 MDH (Yeast) days 3days ASSAY PAM[4 ETERS Wavelenqth (nm ) Sam ole Volum e (!l ReaoenlVolum e (ul) Lao lime lSec.) Kinetic lnterval (Sec.) No. of Readings Krnetic Factor Reaction Tem Derature ('C Reaction Direciion Kinetic 340 50/100 500/1000 60 60 3 ) 1768 37 0 NormalHigh 45 Lln ea rity High 450 0.8 mmdL 0.18 mmol/L al2-8'C 0 LDH > 1820 tU/L 2-Oxoolutarde Tris Buffer (pH 7.510.1 at 25'C) 12 rnmol/L Absorbance Lim it Blank with mmmouL Uo its ([,4 n IU/L Also conlains non- reacU\€ llllers and stabilizers. Programme parameters for specifi c clinical analysers are available on request. REAGENT RECONSTITUTION ASSAYPROCEOURE Allow lhe reagent bottle andAqua-4 ( supplied in the kit )to attain room temperature (15-30'C). Add the amounl of Aqua-4 indicaled on lhe labelto conlents ofeach vial. Swirllo dissolve. do nol shake Vgorously. W orkino Reaoent 1000 uL 100 !L Mix welland aspirale. il Manufactured by : TRANSASIA BIO-MEDICALS LTD., Nalagarh Road, Village Malpur, Baddi, Dist. Solan, (HP) - 173205 In Technical Collaboration with : €RBA diagnostics Mannh€im GmbH Manaust.,69.73, D -682i9, itannheim / cemany EXPECTED VALUES At 37.C Men up to 45 U/l Women up to 34 UI CACULATION Determine the mean absorbance change/min(AAmin) for ev. ery reading,lind the mean yalue. It is recomnEnd€d that sach laboiatory verify lhB rang€ derives refeience inlerval for the population it seryes. ol The general formula lor conwrting absorbance change into lntemational Units ( lU ) ofactiMly is : {AA./min ),TV r 10r IU/L S.V xAbsorptivily x P - OIJAITYCONTROL For qualily control ERBA NORM and ERBA PATH are = Total reaclion l/olume in UL = Sample \]olume in pL = millimolar absorplivity of SV recom6nded. NADH al 340 nm PERFORIiIAI'ICE DATA = Dala contained within thas section is ropresenlative of 6-22 = culette lightpath = 1 cm perfornancs on ERBA systems. Data obtiain6d in your laboratory may differ flom thes6 \ralues. Activity of ALT Linearity: Measuring range: WARNING A'{D PRECAUTIOT.IS For i, vifro diagnostic use. To be handled by enlilted and 450 U/t 450 u/t 0 lntra-assay precision cv SD (U/L) (uiL) (%) Sample I 243 037 152 Sample 2 105 0.67 064 at 37'C (Ui L) = (A IJmin) x Factor (1768) Professionally edLrcaled person. Reagents of the kil are not classified like dangerous but contain less than 0.1% sodium azide - classified as v6ry toxic and dangerous substance for the enlircnment. WASTE lrAl.lAGEM ENT Please rofsr to locallegal requirements. REFERENCES Sample 2 COiT PARISON A comparison between ERAA SGPI(y)and a commercialyalaitaue test (x) using 40 samples gave following results: y= 0.979x- 1.80 u/l r=0996 1. 2. 3. Bradley D. W., Maynard J. E., Emory G and Webster H., Ctin,Cheff . 1A | 1442 ), 1972 Wolf PL., Williams D., Coplon N. aod Coulson A.S.. Clin. Chem. 18 ( 567 ), 1972 Wroblewski F. and LaDue J.S., Proc. Soc- Eper, Biol. and Med. 9'l ( 56S ), 1956. PACK PRESENTATION INTERFERENCES Following substances do not nterfere: haemoglobin up lo 2 5 qn. brl.ubin uo lo 30 ma/dt. tngtyLeades up ro 2000-mg/dl.' Product SY BOI-S: 'The following symbols are used in lhe abetting of ERBA Mannheim kits: aa cEMad. Deee @mp v 120208 E E 8 txi'.3;f''"**) 1l ,****0, l- scsr -l e,"a,on"." \\ wtrh rhe @ rn ffi con"'nrn"r'"rionro'u"" Dre.rve $rqlFa Code 120206 120207 Pack Size Reagent-l SGPT Reaqent 5X6.5ml 5X20ml 10X50ml 5X6.5ml 5X20ml 10X50ml Revision No.: 5 FBCER - cPf Date oflssue : 07/ 10/2015 vto oiueno"to { n**".*.,. EoNil c."""' lso 9001, tso 13485 QIJALITYSYSTEM CERTIFI ED Aqua-{ '1 I X35ml X '100 ml 2X300ml