KIT COMPOSITION
|
Reagent 1 (R-1) Buffer Reagent
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3 x 20 mL
|
|
Reagent 2 (R-2) Antiserum Reagent
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1
x 20 mL
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PERFORMANCE
Precision
The precision for the K-ASSAY Apo B assay was determined using packaged reagents, pooled human serum,
and a Hitachi 717 analyzer.
Precision Assay: Within Run
| Sample I |
Sample II |
Sample III |
N = 20
Mean = 36
SD = 0.7
CV = 2.06%
|
N = 20
Mean = 70.2
SD = 1.5
CV = 2.12%
|
N = 20
Mean = 120.2
SD = 1.7
CV = 1.44%
|
Precision Assay: Between Runs
| Sample I |
Sample II |
Sample III |
N = 10
Mean = 58.6
SD = 1.3
CV = 2.25%
|
N = 10
Mean = 83.3
SD = 1.9
CV = 2.33%
|
N = 10
Mean = 124.5
SD = 1.4
CV = 1.09%
|
|
Correlation
A comparison of the K-ASSAY Apo B assay and a Sigma Apo B Test Kit was performed
using a Hitachi 704. The test results provided the following data:
Y
r
n
X
Y
|
= 1.442 X + 0.00
= 0.885
= 50
= Sigma Apo B Test Kit
= K-ASSAY Apo B assay
|
| X min |
= 26 |
Y min
|
= 42
|
| max |
= 106 |
max
|
= 175
|
| mean |
= 65 |
mean
|
= 107
|
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