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Website : www.erbamannheim.com

S.G.P.T (€
IFCG Method, Kinetic E
INTENDEDUSE SToMGE ANo STABILITY
Diagnostic reagenl for quantitative ir) vltro determination ofALT/ Priorto Reconstituton
GPT (Alanine Aminolransfsrase) in human serum and plasma. Unopened reagenl vial is stable till the epiry dale stated on lhe
label when stor€d d z-a"C.

CLINICAL SIGNIFICANCE Afler Reconsffution

tesser
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
6xl6nt in kidnsy,heart, skeletal muscle, pancreas, spteen and
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 jaun-
SPECIMEN COLLECTION Al{D HANDLTNG
dice. CharacteristicallyAlT/GPT is genel8lly higher than AST/GPT lJse unheamot).tic serum or ptasma (h€parin, EDTA).
in acute Mml or toric hepalitis, wh€r6as for most palients with
lt is recommended to follow NCCLS procedures (or similar
chronic hepalicdisease, ALT/GPTle\els are generally lowerthan standardizsd conditions).
AST/cpT te,/els. Ete\,ated ALT/cpT te\ets ha\e atso been found
Lo$ ot activity:
in e{ensile trauma and muscle disease, circulatory failure with within 3 days al2-8'C
< 10 %
shock, hypoia, myocardial infarction and haemolytic disease. within 3days a|15-25"C < 17 a/o
Stablllty at least 3 monlhs al -20 'C
Dlscard contaminaled specimens.
i,ETHODOLOGY
lnlernalional Federaliorr of clinical chemislry ( lFcc I - ASSAY PAM[4 ETERS
- Kinetic
Wavelenqth (nm ) 340
PR[{CtPt-E Sam ole Volum e (!l 50/100
'+ ReaoenlVolum e (ul) 500/1000
L-Alanrne + 2-Oxoslularate Pyruyale + L-Gldamate
Lao lime lSec.) 60
+ NADH '"" > Kinetic lnterval (Sec.) 60
Pyru\,€le L-Lactaie + NAD
No. of Readings 3
ALT : Alanine aminotransferase Krnetic Factor 1768
LOH : Lactale dehydrogenase Reaction Tem Derature ('C ) 37
Reaction Direciion
REAGENI COMPOSITION ( when roconstituled as dirsclsd ) 0
REAGENTl:SGPTReag€nt
NormalHigh 45
500 mmdL 0
MDH (Yeast) 0.18 mmol/L Lln ea rity High 450
LDH > 1820 tU/L Absorbance Lim it ([,4 n 0.8
2-Oxoolutarde 12 rnmol/L Blank with
Tris Buffer (pH 7.510.1 at 25'C) mmmouL Uo its 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 W orkino Reaoent 1000 uL
Vgorously. 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 CACULATION
At 37.C Determine the mean absorbance change/min(AAmin) for ev.
Men up to 45 U/l ery reading,lind the mean yalue.
Women up to 34 UI
The general formula lor conwrting absorbance change into
It is recomnEnd€d that sach laboiatory verify lhB rang€ ol lntemational Units ( lU ) ofactiMly is :
derives refeience inlerval for the population it seryes.
{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
recom6nded. SV = Sample \]olume in pL
= millimolar absorplivity of
NADH al 340 nm
PERFORIiIAI'ICE DATA = 6-22
Dala contained within thas section is ropresenlative of = culette lightpath = 1 cm
perfornancs on ERBA systems. Data obtiain6d in your laboratory Activity of ALT
may differ flom thes6 \ralues. at 37'C (Ui L) = (A IJmin) x Factor (1768)

Linearity: 450 U/t WARNING A'{D PRECAUTIOT.IS

Measuring range: 0 450 u/t For i, vifro diagnostic use. To be handled by enlilted and
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
lntra-assay precision
(uiL)
SD (U/L) cv (%) dangerous substance for the enlircnment.

Sample I 243 037 152

WASTE lrAl.lAGEM ENT
Sample 2 105 0.67 064 Please rofsr to locallegal requirements.

REFERENCES

1. Bradley D. W., Maynard J. E., Emory G and Webster H.,

Sample 2 Ctin,Cheff . 1A | 1442 ), 1972
2. Wolf PL., Williams D., Coplon N. aod Coulson A.S.. Clin.
Chem. 18 ( 567 ), 1972
COiT PARISON
A comparison between ERAA SGPI(y)and a commercialyalaitaue
3. Wroblewski F. and LaDue J.S., Proc. Soc- Eper, Biol. and
Med. 9'l ( 56S ), 1956.
test (x) using 40 samples gave following results:
y= 0.979x- 1.80 u/l
r=0996
PACK PRESENTATION
INTERFERENCES Product Pack Reagent-l
Code
Aqua-{
Following substances do not nterfere: Size SGPT Reaqent
haemoglobin up lo 2 5 qn. brl.ubin uo lo 30 ma/dt. tngtyLeades up 5X6.5ml 5X6.5ml
ro 2000-mg/dl.'
120206 '1 X35ml
120207 5X20ml 5X20ml I X '100 ml
SY BOI-S: 120208 10X50ml 10X50ml 2X300ml
'The following symbols are used in
lhe abetting of
ERBA Mannheim kits:

E aa cEMad. Deee @mp v

\\ wtrh rhe Dre.rve $rqlFa Revision No.: 5 FBCER - cPf
Date oflssue : 07/ 10/2015
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