Rheumatoid Factor KAI-031 (K-ASSAY)
For In Vitro Diagnostic Use
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% |
