Schemes and Performance Evaluation Criteria of Korean Association of External Quality Assessment (KEQAS) for Improving Laboratory Testing
2021; 41(2): 230-239
Ann Lab Med 2017; 37(3): 267-271
Published online May 1, 2017 https://doi.org/10.3343/alm.2017.37.3.267
Copyright © Korean Society for Laboratory Medicine.
Chun Kiat Lee, M.S.1, Hong Kai Lee, Ph.D.1, Christopher Wei Siong Ng, B.S.1, Lily Chiu, M.S.1, Julian Wei-Tze Tang, M.D.2,3, Tze Ping Loh, M.D.1, and Evelyn Siew-Chuan Koay, Ph.D.1,4
Department of Laboratory Medicine1, National University Hospital, Singapore; Leicester Royal Infirmary2, University Hospitals of Leicester NHS Trust, Leicester, United Kingdom; Department of Infection, Immunity, Inflammation3, University of Leicester, Leicester, United Kingdom; Department of Pathology4, Yong Loo Lin School of Medicine, National University of Singapore, Singapore
Correspondence to: Evelyn Siew-Chuan Koay
Department of Pathology, Yong Loo Lin School of Medicine, National University of Singapore, 21, Lower Kent Ridge Road, 119077, Singapore
Tel: +65-6772-4564
Fax: +65-6772-4407
E-mail: evelyn_koay@nuhs.edu.sg
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Owing to advancements in molecular diagnostics, recent years have seen an increasing number of laboratories adopting respiratory viral panels to detect respiratory pathogens. In December 2015, the NxTAG respiratory pathogen panel (NxTAG RPP) was approved by the United States Food and Drug Administration. We compared the clinical performance of this new assay with that of the xTAG respiratory viral panel (xTAG RVP) FAST v2 using 142 clinical samples and 12 external quality assessment samples. Discordant results were resolved by using a laboratory-developed respiratory viral panel. The NxTAG RPP achieved 100% concordant negative results and 86.6% concordant positive results. It detected one coronavirus 229E and eight influenza A/H3N2 viruses that were missed by the xTAG RVP FAST v2. On the other hand, the NxTAG RPP missed one enterovirus/rhinovirus and one metapneumovirus that were detected by FAST v2. Both panels correctly identified all the pathogens in the 12 external quality assessment samples. Overall, the NxTAG RPP demonstrated good diagnostic performance. Of note, it was better able to subtype the influenza A/H3N2 viruses compared with the xTAG RVP FAST v2.
Keywords: Respiratory tract infections, Respiratory viral panel, Evaluation, Molecular diagnostics