KIT COMPOSITION
|
Reagent 1 (R-1) Buffer Reagent
|
3 x 20 mL
|
|
Reagent 2 (R-2) Antiserum Reagent
|
1
x 20 mL
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PERFORMANCE
Precision
The precision for the K-ASSAY Apo AI assay was determined using packaged reagents, pooled human serum,
and a Hitachi 704 analyzer.
Precision Assay: Within Run
| Sample I |
Sample II |
Sample III |
N = 20
Mean = 83.1
SD = 1.6
CV = 1.87%
|
N = 20
Mean = 142.6
SD = 2.3
CV = 1.60%
|
N = 20
Mean = 189.0
SD = 2.9
CV = 1.51%
|
Precision Assay: Between Runs
| Sample I |
Sample II |
Sample III |
N = 10
Mean = 85.9
SD = 1.1
CV = 1.28%
|
N = 10
Mean = 136.5
SD = 1.437
CV = 1.05%
|
N = 10
Mean = 185.9
SD = 2.9
CV = 1.57%
|
|
Correlation
A comparison of the K-ASSAY Apo AI assay and a Sigma Apo AI Test Kit was performed
using a Hitachi 704. The test results provided the following data
Y
r
n
X
Y
|
= 0.980 X + 4.776
= 0.970
= 55
= Sigma Apo AI Test Kit
= K-ASSAY Apo AI assay
|
| X min |
= 91 |
Y min
|
= 89
|
| max |
= 200 |
max
|
= 213
|
| mean |
= 146 |
mean
|
= 147
|
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%
|
|
Tel: (206) 575-8068