2020; 40(5): 351-360
Ann Lab Med 2020; 40(5): 349-350
Published online September 1, 2020 https://doi.org/10.3343/alm.2020.40.5.349
Copyright © Korean Society for Laboratory Medicine.
COVID-19 Testing in South Korea: Current Status and the Need for Faster Diagnostics
1Department of Laboratory Medicine, Kyung Hee University Hospital, Kyung Hee University School of Medicine, Seoul, Korea; 2Department of Laboratory Medicine, University of Ulsan, College of Medicine and Asan Medical Center, Seoul, Korea; 3GC Genome, Yongin, Korea; 4Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea
Correspondence to: Mina Hur, M.D., Ph.D.
Department of Laboratory Medicine, Konkuk University School of Medicine, Konkuk University Medical Center, 120-1 Neungdong-ro, Hwayang-dong, Gwangjin-gu, Seoul 05030, Korea
Tel: +82-2-2030-5581; Fax: +82-2-2636-6764
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.
Coronavirus Disease 2019 (COVID-19) has caused an outbreak in China and is spreading worldwide . As of March 23, 2020, the epidemic has spread exponentially in South Korea, with more than 8,961 patients found positive based on 338,036 tests conducted . In the aftermath of the Middle East respiratory syndrome (MERS) outbreak in 2015, the South Korean Government established a system that enables emergency use authorization (EUA) of
As local communities continue to be at risk of the virus spread, on February 23 2020, South Korea raised its national infectious disease alert to the highest level and further mobilized its resources to prevent the spread of COVID-19 . A vast number of real-time RT PCR testing is being carried out thanks to the timely implementation of EUA; however, the country’s diagnostic capacity requires further improvement such as addressing the need to shorten the 6-hr turnaround time for testing in situations such as the current COVID-19 crisis. It is also noticeable that a large-scale real-time RT PCR testing is difficult to be implemented in countries with limited resources.
Considering this, what can be done to further improve effectiveness in diagnostic testing? To reduce the spread of COVID-19, the World Health Organization (WHO) has opened its Emergency Use Listing procedure for new submissions; as of February 12, 2020, 220 IVDs have been listed that will be evaluated for analytical sensitivity. Additionally, there are six commercialized near point-of-care (POC) nucleic acid tests (NATs) and nine near-POC NATs under development . However, POC-NATs, developed for rapid diagnosis and use under limited resources, are rarely implemented in outbreak situations caused by novel pathogens. South Korea, despite its robust testing capacity, is no exception to this discrepancy. The Xpert Xpress SARS-CoV-2 (Cepheid, Sunnyvale, CA) and BioFire COVID-19 Test (BioFire Diagnostics, Salt Lake City, UT), which can be tested within 45 minutes, received EUA from the United States FDA as of March 23, 2020 . It is expected to be useful in these urgent situations. In order to cope with other novel infectious diseases that may occur in the future, a system for developing, accrediting, and distributing rapid diagnostic testing, such as POC-NATs, should be established.
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