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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2
x 7 mL
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PERFORMANCE
Precision
The precision for the K-ASSAY Alpha-1 AG 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 = 32.5
SD = 0.53
CV = 1.6%
|
N = 20
Mean = 92.3
SD = 0.6
CV = 0.7%
|
N = 20
Mean = 233.7
SD = 2.17
CV = 0.9%
|
Precision Assay: Between Runs
| Sample I |
Sample II |
Sample III |
N = 10
Mean = 54.6
SD = 0.69
CV = 1.27%
|
N = 10
Mean = 104.7
SD = 0.93
CV = 0.89%
|
N = 10
Mean = 198.6
SD = 1.37
CV = 0.69%
|
|
Correlation
A comparison of the K-ASSAY Alpha-1 AG assay and a Binding Site Alpha-1 AG RID Test Kit was
performed using a Hitachi 717. The test results provided the following data:
Y
r
n
X
Y
|
= 1.016 X + 3.547
= 0.995
= 37
= Binding Site Alpha-1 AG RID
= K-ASSAY Alpha-1 AG assay
|
| X min |
= 35 |
Y min
|
= 37
|
| max |
= 195 |
max
|
= 201
|
| mean |
= 74 |
mean
|
= 79
|
Assay Range
10-200 mg/dL (multi-point calibration)
INTERFERENCE
Ascorbic Acid
Bilirubin F and C
Hemoglobin
Lipemia
|
No interference up to 200 mg/dL
No interference up to 20 mg/dL
No interference up to 500 mg/dL
No interference up to 4%
|
|
Tel: (206) 575-8068