국내 중증 급성 호흡기 증후군 코로나 바이러스의 검사실 내 진단: 현재, 한계점 그리고 직면한 과제
Laboratory Diagnosis of Coronavirus Disease 19 (COVID-19) in Korea: Current Status, Limitation, and Challenges
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초록
2019년 12월, 중국 후베이성 우한시에서 COVID-19환자가처음으로 보고되었다. 그 이후 국내에서 신종 코로나 바이러스에 의해 야기된 중증 급성 호흡기 증후군 환자가 급격하게 증가하였다. 이러한 새로운 변종 바이러스는 기침, 인후통, 비루, 호흡곤란, 폐렴 및 기타 폐질환을 유발한다. 중증 급성 호흡기 증후군 코로나 바이러스 2는 RNA바이러스로, 실시간 역전사효소중합효소 연쇄반응을 통한 분자진단 검사가 COVID-19의 진단에 폭 넓게 사용되고 있다. 국내 질병관리본부와 식품의약품안전처의 긴급 사용 허가 승인에 따라, 건강한 사람과 COVID- 19 환자로부터 검체를 채취하여 진단검사의학적인 방법을 통해진단을 수행하고 있다. 기존에 출판된 많은 문헌 고찰을 통해, 본연구에서는 역학, 증상 및 질병관리본부의 승인을 받은 현재의검사실 내 COVID-19 분자 진단 방법, 분자 진단 검사와 혈청학적 진단의 차이, 임상 검체 가이드라인 등을 다시 한 번 확인하고자 하였다. 추가적으로 본 연구를 통해 국내 의료기관 내 의료종사자 및 임상병리사들의 병원 감염을 예방하고자 생물학적 안전에 관한 가이드라인을 확인하였다. 국내 임상병리사들의 경험과 그로부터 얻은 교훈을 통해 국내외 COVID-19 팬데믹 상황으로부터 국민의 안전을 지킬 수 있는 단초를 제공할 수 있을 것이라 사료된다.
Abstract
In December 2019, the first coronavirus disease- 2019 (COVID-19) patient was reported in Wuhan, Hubei Province, China. Since then, the number of patients who suffered severe acute respiratory syndrome caused by the novel Coronavirus (SARS-CoV-2 or 2019-nCoV) has increased dramatically in Korea. This new variant virus induces pulmonary diseases, including cough, sore throat, rhinorrhea, dyspnea, and pneumonia. Because SARS-CoV-2 is an RNA virus, real-time reversetranscriptase PCR has been used widely to diagnose COVID-19. As the Korea Centers for Disease Prevention and Control (KCDC) and Ministry of Food & Drug Safety (MFDS) approved emergency use authorization, clinical specimens collected from COVID-19 patients and even healthy people have been clinically diagnosed by laboratory medicine. Based on a literature search, this paper reviews the epidemiology, symptoms, molecular diagnostics approved by KCDC, a current diagnosis of COVID-19 in the laboratories, the difference between molecular and serological diagnosis, and guidelines for clinical specimens. In addition, the Korean guidelines of biosafety for clinical laboratory scientists are evaluated to prevent healthcare-associated infection. The author’s experience and lessons as clinical laboratory scientists will provide valuable insights to protect the domestic and international health community in this COVID-19 pandemic around the world.
참고문헌 (38)
- King AMQ, "Family - Coronaviridae", pp.806~828 (2012), Elsevier
- Shuo Su, "Epidemiology, Genetic Recombination, and Pathogenesis of Coronaviruses", Trends in Microbiology, 24(6), pp.490~502 (2016), Elsevier BV[DOI]
- Terho Heikkinen, "The common cold", The Lancet, 361(9351), pp.51~59 (2003), Elsevier BV[DOI]
- "Cumulative number of reported probable cases of SARS" (2020)[URL]
- Christian Drosten, "Identification of a Novel Coronavirus in Patients with Severe Acute Respiratory Syndrome", New England Journal of Medicine, 348(20), pp.1967~1976 (2003), Massachusetts Medical Society[DOI]
- NS Zhong, "Epidemiology and cause of severe acute respiratory syndrome (SARS) in Guangdong, People's Republic of China, in February, 2003", The Lancet, 362(9393), pp.1353~1358 (2003), Elsevier BV[DOI]
- Ali M. Zaki, "Isolation of a Novel Coronavirus from a Man with Pneumonia in Saudi Arabia", New England Journal of Medicine, 367(19), pp.1814~1820 (2012), Massachusetts Medical Society[DOI]
- "MERS situation update, January 2020" (2020)[URL]
- Na Zhu, "A Novel Coronavirus from Patients with Pneumonia in China, 2019", New England Journal of Medicine, 382(8), pp.727~733 (2020), Massachusetts Medical Society[DOI]
- Gorbalenya AE, "The species Severe acute respiratory syndrome-related coronavirus: classifying 2019-nCoV and naming it SARS-CoV-2", Nature Microbiology, 5(4), pp.536~544 (2020), Springer Science and Business Media LLC[DOI]
- "WHO Director-General's remarks at the media briefing on 2019-nCoV on 11 February 2020" (2020)[URL]
- Jeong-Min Kim, "Identification of Coronavirus Isolated from a Patient in Korea with COVID-19", Osong Public Health and Research Perspectives, 11(1), pp.3~7 (2020), 질병관리청[DOI]
- Ensheng Dong, "An interactive web-based dashboard to track COVID-19 in real time", The Lancet Infectious Diseases, 20(5), pp.533~534 (2020), Elsevier BV[DOI]
- Chen Wang, "A novel coronavirus outbreak of global health concern", The Lancet, 395(10223), pp.470~473 (2020), Elsevier BV[DOI]
- "COVID-19 confirmed patient status" (2020)[URL]
- "18 Feb 2020 COVID-19 status" (2020)[URL]
- "Korea, Domestic status of COVID-19, 20 Apr" (2020)[URL]
- 기모란, "Epidemiologic characteristics of early cases with 2019 novel coronavirus (2019-nCoV) disease in Korea", Epidemiology and Health, 42, pp.1~7 (2020), 한국역학회[DOI]
- Dawei Wang, "Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus–Infected Pneumonia in Wuhan, China", JAMA, 323(11), pp.1061~1069 (2020), American Medical Association (AMA)[DOI]
- Jin Yong Kim, "The First Case of 2019 Novel Coronavirus Pneumonia Imported into Korea from Wuhan, China: Implication for Infection Prevention and Control Measures", Journal of Korean Medical Science, 35(5), pp.1~4 (2020), 대한의학회[DOI]
- Eu Suk Kim, "Clinical Course and Outcomes of Patients with Severe Acute Respiratory Syndrome Coronavirus 2 Infection: a Preliminary Report of the First 28 Patients from the Korean Cohort Study on COVID-19", Journal of Korean Medical Science, 35(13), pp.1~12 (2020), 대한의학회[DOI]
- Peong Gang Park, "Out-of-Hospital Cohort Treatment of Coronavirus Disease 2019 Patients with Mild Symptoms in Korea: an Experience from a Single Community Treatment Center", Journal of Korean Medical Science, 35(13), pp.1~6 (2020), 대한의학회[DOI]
- Guangming Ye, "Clinical characteristics of severe acute respiratory syndrome coronavirus 2 reactivation", Journal of Infection, 80(5), pp.e14~e17 (2020), Elsevier BV[DOI]
- 안대균, "Current Status of Epidemiology, Diagnosis, Therapeutics, and Vaccines for Novel Coronavirus Disease 2019 (COVID-19)", Journal of Microbiology and Biotechnology, 30(3), pp.313~324 (2020), 한국미생물·생명공학회
- "Laboratory testing for coronavirus disease (COVID-19)in suspected human cases: interim guidance, 19 March 2020" (2020)[URL]
- Victor M Corman, "Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR", Eurosurveillance, 25(3), pp.2000045~ (2020), European Centre for Disease Control and Prevention (ECDC)[DOI]
- Ki Ho Hong, "Guidelines for Laboratory Diagnosis of Coronavirus Disease 2019 (COVID-19) in Korea", Annals of Laboratory Medicine, 40(5), pp.351~360 (2020), 대한진단검사의학회[DOI]
- "Product information of emergency use authorizations for COVID-19 genetic detection tests" (2020)[URL]
- "Guidelines for the laboratory diagnosis of COVID-19 in Korea" (2020)[URL]
- "COVID-19 response guidelines" (2020)[URL]
- Xiong Wang, "Comparison of nasopharyngeal and oropharyngeal swabs for SARS-CoV-2 detection in 353 patients received tests with both specimens simultaneously", International Journal of Infectious Diseases, 94, pp.107~109 (2020), Elsevier BV[DOI]
- Michael J. Loeffelholz, "Laboratory diagnosis of emerging human coronavirus infections – the state of the art", Emerging Microbes & Infections, 9(1), pp.747~756 (2020), Informa UK Limited[DOI]
- Zhengtu Li, "Development and clinical application of a rapid IgM‐IgG combined antibody test for SARS‐CoV‐2 infection diagnosis", Journal of Medical Virology, 92(9), pp.1518~1524 (2020), Wiley[DOI]
- Sandeep Kumar Vashist, "In Vitro Diagnostic Assays for COVID-19: Recent Advances and Emerging Trends", Diagnostics, 10(4), pp.202~ (2020), MDPI AG[DOI]
- Wenling Wang, "Detection of SARS-CoV-2 in Different Types of Clinical Specimens", JAMA, 323, pp.1843~1844 (2020), American Medical Association (AMA)[DOI]
- Wei Zhang, "Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes", Emerging Microbes & Infections, 9(1), pp.386~389 (2020), Informa UK Limited[DOI]
- Iwen PC, "Safety considerations in the laboratory testing of specimens suspected or known to contain the severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)", Am J Clin Pathol, 153, pp.567~570 (2020)[DOI]
- Zhiruo Zhang, "Protecting healthcare personnel from 2019-nCoV infection risks: lessons and suggestions", Frontiers of Medicine, 14(2), pp.229~231 (2020), Springer Science and Business Media LLC[DOI]
