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KIT COMPOSITION
Reagent 1 (R-1) Buffer Reagent 4 x 20 ml
Reagent 2 (R-2) RF Reagent 2 x 8 ml
PERFORMANCE
Precision
The precision for the K-ASSAY Rheumatoid Factor was determined using packaged reagents, pooled
human serum, and a Hitachi 717 automatic analyzer.
Precision Assay: Within Run
| Sample I |
Sample II |
N = 20
Mean = 3.3
SD = 0.86
CV = 26.197%
|
N = 20
Mean = 110.15
SD = 1.5
CV = 1.359%
|
Precision Assay: Between Runs
| Sample I |
Sample II |
Sample III |
N = 10
Mean = 7.9
SD = 2.13
CV = 26.98%
|
N = 10
Mean = 33
SD = 1.33
CV = 4.04%
|
N = 10
Mean = 106.3
SD = 2.06
CV = 1.94%
|
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Assay Range
5-320 IU/ml (multi-point calibration)
Correlation
Y
r
n
X
Y
|
= 0.876x - 20.268
= 0.984
= 43
= company A's ITA
= K-ASSAY Rheumatoid Factor
|
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