Lab Med Qual Assur.  2020 Dec;42(4):194-199. 10.15263/jlmqa.2020.42.4.194.

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

• Hur KH
• Park K
• Yang JJ
• Kim MN
• Sung H

• KMID: 2510301
• DOI: http://doi.org/10.15263/jlmqa.2020.42.4.194

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 emergencyuse 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.

Keyword

COVID-19; SARS-CoV-2; Reference materials; External quality assessment