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