An Investigation of Rheumatoid Factor Detection Kits for Their Accuracy and Reproducibility

摘要

Using a literature search for background information, a protocol was developed for evaluating the product characteristics or performance claims of products sold specifically for the determination of rheumatoid factor. This report describes the methods, results, and conclusions of the experiment evaluation of these in vitro diagnostic products, using both qualitative and quantitative detection kits. Because of suspected sources of variability, the experimental protocol was designed to evaluate not only the replicate and day-to-day variability but also lot-to-lot and technician-to-technician variability. The experimental protocol involved studies on 300 patient specimens and two standard serum pools calibrated in international units. The latter was investigated to see the effect of expressing results in international units on interproduct variability.