|
KIT COMPOSITION
Reagent 1 (R-1) Buffer Reagent 2 x 22 ml
Reagent 2 (R-2) Antiserum Reagent 1 x 7 ml
AT-III Calibrator 1 x 1 ml
PERFORMANCE
Precision
The precision for the K-ASSAY AT-III assay was determined using packaged reagents, pooled human plasma,
and a Hitachi 717 analyzer.
Precision Assay: Within Run
| Sample I |
Sample II |
Sample III |
N = 20
Mean = 15.7
SD = 0.109
CV = 0.69%
|
N = 20
Mean = 21.8
SD = 0.165
CV = 0.76%
|
N = 20
Mean = 30.3
SD = 0.338
CV = 1.12%
|
Precision Assay: Between Runs
| Sample I |
Sample II |
Sample III |
N = 10
Mean = 43.01
SD = 0.35
CV = 0.8%
|
N = 10
Mean = 23.03
SD = 0.298
CV = 1.295%
|
N = 10
Mean = 11.34
SD = 0.303
CV = 2.668%
|
|
Correlation
A comparison of the K-ASSAY AT-III assay and a Binding Site AT-III RID Kit was performed
using a Hitachi 717. The test results provided the following data:
Y
r
n
X
Y
|
= 0.909 X + 6.462
= 0.864
= 39
= Binding Site AT-III RID Kit
= K-ASSAY AT-III assay
|
| X min |
= 11.2 |
Y min
|
= 14.7
|
| max |
= 36.0 |
max
|
= 38.2
|
| mean |
= 24.4 |
mean
|
= 28.6
|
INTERFERENCE
Bilirubin F and C
Hemoglobin
Lipemia
|
No interference up to 20 mg/dl
No interference up to 500 mg/dl
No interference up to 5%
|
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Tel: (206) 575-8068