Editorial

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Ann Lab Med 2020;40:349-350

https://doi.org/10.3343/alm.2020.40.5.349
ISSN 2234-3806 • eISSN 2234-3814
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Young Jin Kim , M.D., Ph.D.1, Heungsup Sung , M.D., Ph.D.2, Chang-Seok Ki , M.D., Ph.D.3,
and Mina Hur , M.D., Ph.D.4
Department of Laboratory Medicine, Kyung Hee University Hospital, Kyung Hee University School of Medicine, Seoul, Korea; 2Department of Laboratory
1

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

COVID-19 Testing in South Korea: Current Status and

the Need for Faster Diagnostics

Coronavirus Disease 2019 (COVID-19) has caused an outbreak of real-time RT PCR testing is being carried out thanks to the
in China and is spreading worldwide [1]. As of March 23, 2020, timely implementation of EUA; however, the country’s diagnostic
the epidemic has spread exponentially in South Korea, with capacity requires further improvement such as addressing the
more than 8,961 patients found positive based on 338,036 need to shorten the 6-hr turnaround time for testing in situations
tests conducted [2]. In the aftermath of the Middle East respira- such as the current COVID-19 crisis. It is also noticeable that a
tory syndrome (MERS) outbreak in 2015, the South Korean large-scale real-time RT PCR testing is difficult to be imple-
Government established a system that enables emergency use mented in countries with limited resources.
authorization (EUA) of in vitro diagnostics (IVDs) for infectious Considering this, what can be done to further improve effec-
diseases [3]. As a result, South Korea could swiftly approve its tiveness in diagnostic testing? To reduce the spread of CO-
first real-time reverse transcription (RT) PCR kit for COVID-19 VID-19, the World Health Organization (WHO) has opened its
testing on February 4, 2020 [4], following the country’s first re- Emergency Use Listing procedure for new submissions; as of
ported case of COVID-19 on January 20, 2020 [5]. Shortly after, February 12, 2020, 220 IVDs have been listed that will be eval-
four additional kits were approved for testing [6]. Currently, uated for analytical sensitivity. Additionally, there are six com-
15,000 to 20,000 tests per day are being carried out by national mercialized near point-of-care (POC) nucleic acid tests (NATs)
central labs and 95 non-governmental clinical laboratories. and nine near-POC NATs under development [8]. However,
These laboratories have been all certified by Korean Society for POC-NATs, developed for rapid diagnosis and use under limited
Laboratory Medicine (KSLM) and have also completed external resources, are rarely implemented in outbreak situations caused
quality assessments by the Korean Association of External Qual- by novel pathogens. South Korea, despite its robust testing ca-
ity Assessment Service (KEQAS). This issue of Ann Lab Med pacity, is no exception to this discrepancy. The Xpert Xpress
presents the guidelines for the laboratory diagnosis of CO- SARS-CoV-2 (Cepheid, Sunnyvale, CA) and BioFire COVID-19
VID-19, which is followed in clinical laboratories in South Korea Test (BioFire Diagnostics, Salt Lake City, UT), which can be
[6]. tested within 45 minutes, received EUA from the United States
As local communities continue to be at risk of the virus spread, FDA as of March 23, 2020 [9]. It is expected to be useful in
on February 23 2020, South Korea raised its national infectious these urgent situations. In order to cope with other novel infec-
disease alert to the highest level and further mobilized its re- tious diseases that may occur in the future, a system for devel-
sources to prevent the spread of COVID-19 [7]. A vast number oping, accrediting, and distributing rapid diagnostic testing,

© Korean Society for Laboratory Medicine

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.

https://doi.org/10.3343/alm.2020.40.5.349 www.annlabmed.org  349
 Kim YJ, et al.
COVID-19 testing in South Korea

such as POC-NATs, should be established. Control and Prevention, Korea Centers for Disease Control and Preven-
tion. Report on the epidemiological features of Coronavirus Disease
2019 (COVID-19) outbreak in the Republic of Korea from January 19 to
AUTHORS’ DISCLOSURES OF POTENTIAL March 2, 2020. J Korean Med Sci 2020;35:e112.
CONFLICTS OF INTEREST 2. Korea Centers for Disease Control and Prevention. The update of COV-
ID-19 in Korea as of 23 March. http://ncov.mohw.go.kr/tcmBoardView.
do?brdId=&brdGubun=&dataGubun=&ncvContSeq=353678&contSeq
No potential conflicts of interest relevant to this article were re- =353678&board_id=&gubun=ALL (Updated on Mar 23, 2020).
ported. 3. Park JS, Choi YS, Yoo CK. Emergency Use Authorization of in-vitro diag-
nostics for infectious disease. Public Health Weekly Report 2017;10:
555-9.
ACKNOWLEDGEMENTS 4. Korea Centers for Disease Control and Prevention. The update of COV-
ID-19 in Korea as of 4 February.http://ncov.mohw.go.kr/tcmBoardView.
None. do?brdId=&brdGubun=&dataGubun=&ncvContSeq=352683&contSeq
=352683&board_id=&gubun=ALL (Updated on Feb 4, 2020).
5. Kim JY, Ko JH, Kim Y, Kim YJ, Kim JM, Chung YS, et al. Viral load kinet-
AUTHOR CONTRIBUTIONS ics of SARS-CoV-2 infection in first two patients in Korea. J Korean Med
Sci 2020;35:e86.
6. Hong KH, Lee SW, Kim TS, Huh HJ, Lee J, Kim SY, et al. Guidelines for the
YJK, CK, and MH wrote and revised the manuscript; HS served
Laboratory Diagnosis of COVID-19 in Korea. Ann Lab Med 2020;40:351-
as a scientific advisor and revised the manuscript; all authors 60.
reviewed and approved the manuscript. 7. Korea Centers for Disease Control and Prevention. The update of COV-
ID-19 in Korea as of 23 February. http://ncov.mohw.go.kr/tcmBoard-
View.do?brdId=&brdGubun=&dataGubun=&ncvContSeq=353064&con
RESEARCH FUNDING tSeq=353064&board_id=&gubun=ALL (Updated on Feb 25, 2020).
8. Foundation for Innovative New Diagnostics. COVID-19 outbreak: diag-
None declared. nostic update. https://www.finddx.org/covid-19/pipeline (Updated on
Mar 14, 2020).
9. U.S Food & Drug Administration, Emergency Use Authorization. https://
ORCID www.fda.gov/emergency-preparedness-and-response/mcm-legal-regu-
latory-and-policy-framework/emergency-use-authorization (Updated on
Mar 23, 2020).
Young Jin Kim https://orcid.org/0000-0001-8182-2433
Heungsup Sung https://orcid.org/0000-0002-6062-4451
Chang-Seok Ki https://orcid.org/0000-0001-7679-8731
Corresponding author: Mina Hur, M.D., Ph.D.
Mina Hur https://orcid.org/0000-0002-4429-9978 Department of Laboratory Medicine, Konkuk University School of Medicine,
Konkuk University Medical Center, 120-1 Neungdong-ro, Hwayang-dong,
Gwangjin-gu, Seoul 05030, Korea
REFERENCES Tel: +82-2-2030-5581; Fax: +82-2-2636-6764
E-mail: dearmina@hanmail.net
1. Korean Society of Infectious Diseases, Korean Society of Pediatric Infec-
tious Diseases, Korean Society of Epidemiology, Korean Society for Anti- Key Words: COVID-19, SARS-CoV-2, Korea, Diagnostic testing,
microbial Therapy, Korean Society for Healthcare-associated Infection Outbreak, Emergency use authorization

350  www.annlabmed.org https://doi.org/10.3343/alm.2020.40.5.349