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pISSN 2384-2458 eISSN 2288-7261
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J Lab Med Qual Assur 2020; 42(4): 194-199

Published online December 31, 2020

https://doi.org/10.15263/jlmqa.2020.42.4.194

Copyright © Korean Association of External Quality Assessment Service.

Current Status of Proficiency Testing Programs and Development of Reference Materials for Severe Acute Respiratory Syndrome Coronavirus 2 Molecular Diagnostic Tests

Kyu-Hwa Hur*, Kuenyoul Park*, John Jeongseok Yang, Mi-Na Kim, and Heungsup Sung

Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Correspondence to:Heungsup Sung
Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul 05505, Korea
Tel +82-2-3010-4499
Fax +82-2-478-0884
E-mail sung@amc.seoul.kr
*These authors contributed equally to this work.

Received: October 6, 2020; Revised: October 27, 2020; Accepted: October 29, 2020

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

Laboratory preparedness and rapid expansion of testing capacity are essential for controlling the coronavirus disease 2019 (COVID-19) outbreak. Such efforts require the prompt implementation of authorized emergency-use test kits and extensive and decentralized screening by qualified clinical laboratories. Until August 2020, 113 clinical laboratories in South Korea were approved to perform molecular tests of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) based on five proficiency testing evaluations conducted by the Korean Association of External Quality Assessment Service. SARS-CoV-2-positive clinical samples or reference materials are key elements for the development, validation, and verification of the SARS-CoV-2 molecular diagnostics. The developed reference materials have a wide range of applications, and they are available as nationwide/international external quality assessment (EQA) materials as well as day-to-day internal quality control materials. This review discusses the current status of the nationwide/international EQAs and development of SARS-CoV-2 reference materials.

Keywords: COVID-19, SARS-CoV-2, Reference materials, External quality assessment

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