AST/GOT

Instruction for use : Ref : ASAT-0200 12 x 20 mL

Convertion Factor : U/L x 0.0167 = µkat/L ASAT-0400 9 x 50 mL

APPLICATION Selectra Pro Serie & Flexor EL Serie

General Sample types
Name AST/GOT Normal
Abbreviated name ASAT Allowed Yes
Code Predilution No 0

Mode Kinetic Reference values

Wavelength 340 nm 0 Male XXX - XXX U/L
Test parameters 1

Units U/L Female XXX - XXX U/L

Decimals 1 Pediatric XXX - XXX U/L
Test repeats 1 Panic XXX - XXX U/L
Controls
Control 1 XXX
Concentration limits 15.0 - 250.0 U/L Control 2 XXX
Calibrator name XXX Control 3 XXX
Correlation
Prozone check No Correlation factor 1.000
Correlation offset 0.000 U/L

General Measurement
Name AST/GOT Slope Blank No 0 0
P dil ti
Predilution N
No 0 D
Delay,
l min.
i time
ti 77 0 185 sec
Sample
Sample blank No Alinearity 10 %
normal volume rerun volume* Factor 1.00
Test parameters 2

25.0 µL 13.0 µl Absorbance limits

Reagents Absorbance 0.200 - 2.500 Abs
Reagent blank Yes 3 R. Absorbance 0.900 - 1.900 Abs
normal volume rerun volume*
Reagent addition at - 2.25 minutes (R1) R. Abs. deviation 0.050 Abs
250 µL 262 µl
Reagent addition at 2.90 minutes (R2) 0
0 µL 0 µl 0 9.000 0 9.000 0
Reagent addition at 4.70 minutes (R3) 0 9.000 0 9.000 0
0 µL 0 µl 0 9.000 0

Calibrator Predilution
Name XXX Auto predilution No
Number of standards 1 0
Calibration accepted - 0 0
Calibration

Repeats 3 Cut-off
Interval 28 days Cut-off No
Curvefit 0
0 0 0
0 0 0 9.000 9.000
Auto accept calibration Yes 0 9.000 9.000

N° Used Concentration 0 0
#1 Standard #1 xxx 0 FAUX
0 0 FAUX
0 0 FAUX XXX: Enter data by the user
0 0 FAUX * : For information only
0 0 FAUX
0 0 FAUX
0 0 FAUX (01/2011)
AA-PRO/ELserie-ASAT-1
 Modification from the previous version 1/2
 AST/GOT
Instruction for use : Ref : ASAT-0200 12 x 20 mL
Convertion Factor : U/L x 0.0167 = µkat/L ASAT-0400 9 x 50 mL

APPLICATION Selectra Pro Serie & Flexor EL Serie

0 0 FAUX

PERFORMANCE DATA

Analytical range
The reagent is linear from 15 to 250 U/L.

Detection limit
Determined according to SFBC protocol, the detection limit is equal to 2.0 U/L.

Precision
Within run reproducibility Between run reproducibility

N Mean (U/L) CV% N Mean (U/L) CV%

Level 1 20 15.0 4.8% Level 1 20 25.1 3.9%
Level 2 20 121.5 0.6% Level 2 20 125.4 2.6%

Correlation
A comparative study has been performed on 60 human serum samples.
The sample concentrations were between 10.4 and 359.3 U/L.
The parameters of linear regression are as follows :
Correlation coefficient (r) :0.9992
Linear regression : y= 1.078 x + 1.4 U/L

Interferences
According to SFBC recommendations, some studies have been performed to determine the level of interference
from different compounds:
Unconjugated bilirubin :Negative bias from 22.5 mg/dL.
Conjugated bilirubin :Negative bias from 16 mg/dL.
Turbidity :Positive bias from 500 mg/dL on normal sera.
No significant interference up to 600 mg/dL Triglycerides equivalent on pathological sera.
Other compounds may interfere (see product insert).
Note:
Hemolysed sera should not be used since significant haemolysis may increase AST concentration
because of high level of AST in erythrocytes.

On board stability / Calibration frequency (refrigerated position)

On board stability: 28 days
Calibration frequency: 28 days
Make a new calibration when reagent lots change, when quality control results fall outside the established range
and after a maintenance operation.

(01/2011)
AA-PRO/ELserie-ASAT-1
 Modification from the previous version 2/2