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Analyses of the Proficiency Testing Program and the Performance of Qualitative Reagents for Rheumatoid Factor
J Lab Med Qual Assur 2019;41:105-110
Published online June 30, 2019
© 2019 Korean Association of External Quality Assessment Service.

Jongwon Oh and Hyung-Doo Park

Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Correspondence to: Hyung-Doo Park, Department of Laboratory Medicine and Genetics, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul 06351, Korea, Tel: +82-2-3410-0290 Fax: +82-2-3410-2719 E-mail: nayadoo@hanmail.net
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
 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 reviewedthe 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.
Keywords : Rheumatoid factor, Rheumatoid arthritis, Proficiency testing, Quality control