KIT COMPOSITION
|
Reagent 1 (R-1) Buffer Reagent
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3 x 20 mL
|
|
Reagent 2 (R-2) Antiserum Reagent
|
2
x 10 mL
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PERFORMANCE
Precision
The precision for the K-ASSAY Alpha-1 AT assay was determined using packaged reagents, pooled human serum,
and a Hitachi 717 analyzer.
Precision Assay: Within Run
| Sample I |
Sample II |
N = 20
Mean = 136
SD = 3.13
CV = 2.3%
|
N = 20
Mean = 343
SD = 4.35
CV = 1.27%
|
Precision Assay: Between Runs
| Sample I |
Sample II |
N = 10
Mean = 152
SD = 2.58
CV = 1.70%
|
N = 10
Mean = 355
SD = 2.45
CV = 0.69%
|
|
Correlation
A comparison of the K-ASSAY Alpha-1 AT assay and a Binding Site Alpha-1 AT RID Test Kit was
performed using a Hitachi 717. The test results provided the following data:
Y
r
n
X
Y
|
= 0.708 X + 12.165
= 0.942
= 50
= Binding Site Alpha-1 AT RID
= K-ASSAY Alpha-1 AT assay
|
| X min |
= 86 |
Y min
|
= 69
|
| max |
= 276 |
max
|
= 213
|
| mean |
= 208 |
mean
|
= 160
|
Assay Range
30-325 mg/dL (multi-point calibration)
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