Rheumatoid Factor KAI-031 (K-ASSAY)

For In Vitro Diagnostic Use
CE

Kit composition

Reagent 1 (R-1) Buffer Reagent 4 × 20 ml
Reagent 2 (R-2) RF Reagent 2 × 8 ml

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%

Assay Range

5-320 IU/ml (multi-point calibration)

Correlation

A comparison ofthe K-ASSAY Fibrinogen test and an Incstar Fibrinogen test kit were performed on a Hitachi 717. The test results provided the following data:

Y = 0.876X - 20.268
r = 0.984
n = 43
X = company A's ITA
Y = K-ASSAY Rheumatoid Factor

Interference

Bilirubin F and C No interference up to 20 mg/dl
Hemoglobin No interference up to 500 mg/dl
Lipemia No interference up to 5%