J Lab Med Qual Assur.  2019 Jun;41(2):105-110. 10.15263/jlmqa.2019.41.2.105.

Analyses of the Proficiency Testing Program and the Performance of Qualitative Reagents for Rheumatoid Factor

Affiliations
  • 1Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. nayadoo@hanmail.net

Abstract

BACKGROUND
Rheumatoid factor (RF) is used as one of the diagnostic criteria for rheumatoid arthritis. The purpose of this study was to evaluate qualitative RF reagents used in clinical laboratories in Korea, and to provide basic data that can be used as a reference to improve the quality of RF testing.
METHODS
We reviewed the proficiency testing results for RF from the Korean Association of External Quality Assessment Service (KEQAS) and College of American Pathologists. Moreover, we evaluated five commercially available RF qualitative reagents, including LabSlide RF (IVD Lab Co., Korea), ASAN RA Latex Reagents (Asan Pharmaceuticals Co., Korea), RaPET RF (Stanbio Laboratory, USA), RF Latex Test (Pulse Scientific Inc., Canada), and RF-100 (Teco Diagnostics, USA). Commercially available quality control materials, calibrators, and pooled sera were used in this study. The consistency of qualitative reagents and Kappa statistics were calculated based on the quantitative values of the quality control materials and the mixed sera.
RESULTS
Up to 51.5% of high concentration samples were reported as negative in KEQAS. RF qualitative reagent test results were not consistent among reagent types. The consistency of the qualitative and quantitative test results was between 51% and 100%, and the kappa statistics varied depending on the reagent manufacturer.
CONCLUSIONS
Measurement of RF qualitative reagents used in domestic clinical laboratories was not consistent with the quantitative values, and hence it is necessary to improve the consistency and verify the adequacy of the cut-off value.

Keyword

Rheumatoid factor; Rheumatoid arthritis; Proficiency testing; Quality control

MeSH Terms

Arthritis, Rheumatoid
Chungcheongnam-do
Indicators and Reagents*
Korea
Latex
Quality Control
Rheumatoid Factor*
Indicators and Reagents
Latex
Rheumatoid Factor
Full Text Links
  • JLMQA
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2022 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr