Korean J healthc assoc Infect Control Prev.  2021 Dec;26(2):47-56. 10.14192/kjicp.2021.26.2.47.

Laboratory Diagnosis and Utilization for COVID-19

Affiliations
  • 1Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
  • 2Department of Laboratory Medicine, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, Korea
  • 3Seoul Clinical Laboratories, Yongin, Korea
  • 4Department of Laboratory Medicine and Genetics, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea

Abstract

Since the outbreak of COVID-19 in March 2020, the COVID-19 diagnostic test has become a critical means of national response. Laboratory diagnosis of patients with COVID-19 is essential for not only patient management but also understanding the epidemiology and preventing the spread of infection, such as contact tracing. Real-time reverse transcriptase polymerase chain reaction (RT-PCR), which amplifies and detects viral nucleic acids, is the gold standard for laboratory diagnosis of COVID-19. Currently, various real-time RT-PCR diagnostic kits are commercially available worldwide. Therefore, verifying the sensitivity and specificity of these kits plays an important role in determining their diagnostic value. However, in addition to RTPCR, the point-of-care test that is rapid and affordable by untrained individuals, antibody tests to monitor the immunological course of infected or vaccinated individuals, and large-scale sequencing of SARS-CoV-2 genome are technologies that are also needed in the long-term COVID-19 pandemic. As the COVID-19 pandemic situation intensifies, the need for various diagnostic tests has also increases, and there has been a quantum leap in quality and quantity. This review intends to present a comprehensive perspective on various diagnostic methods and appropriate use of tests approved by the Ministry of Food and Drug Safety in Korea and used for COVID-19 laboratory diagnosis.

Keyword

COVID-19; Diagnostic test; Polymerase chain reaction; SARS-CoV-2

Figure

  • Fig. 1 Appropriate performance characteristics of SARS-CoV-2 tests according to status of the person being tested and the prevalence of SARS-CoV-2 in the population being tested. Non-ideal testing should be utilized by laboratory professional balancing turnaround time and analytical performance in the real world with changing epidemiology such as prevalence.


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Reference

1. World Health Organization. 2021. Weekly epidemiological update on COVID-19 - 1 June 2021. 42nd ed. World Health Organization;Geneva: p. 1–28.
2. Ministry of Health. Coronavirus (COVID-19), Republic of Korea. http://ncov.mohw.go.kr/en/bdBoardList.do?brdId=16&brdGubun=161&dataGubun=&ncvContSeq=&contSeq=&board_id= . Updated on 9 November 2021.
3. Matrajt L, Leung T. 2020; Evaluating the effectiveness of social distancing interventions to delay or flatten the epidemic curve of coronavirus disease. Emerg Infect Dis. 26:1740–8. DOI: 10.3201/eid2608.201093. PMID: 32343222. PMCID: PMC7392458.
Article
4. Liang LL, Tseng CH, Ho HJ, Wu CY. 2020; Covid-19 mortality is negatively associated with test number and government effectiveness. Sci Rep. 10:12567. DOI: 10.1038/s41598-020-68862-x. PMID: 32709854. PMCID: PMC7381657.
Article
5. U.S. Food and Drug Administration. 2021. South Korea’s response to COVID-19. Food and Drug Administration. U.S. Food and Drug Administration;Silver Spring: p. 1–25.
6. World Health Organization. 2020. Laboratory testing for 2019 novel coronavirus (2019-nCoV) in suspected human cases. World Health Organization;Geneva: p. 1–7.
7. Hong KH, Lee SW, Kim TS, Huh HJ, Lee J, Kim SY, et al. 2020; Guidelines for laboratory diagnosis of coronavirus disease 2019 (COVID-19) in Korea. Ann Lab Med. 40:351–60. DOI: 10.3343/alm.2020.40.5.351. PMID: 32237288. PMCID: PMC7169629.
Article
8. Tom MR, Mina MJ. 2020; To interpret the SARS-CoV-2 test, consider the cycle threshold value. Clin Infect Dis. 71:2252–4. DOI: 10.1093/cid/ciaa619. PMID: 32435816. PMCID: PMC7314112.
Article
9. Central Disaster Management Headquarters. 2021. Response guideline to COVID-19. 10th ed. Korea Disease Control and Prevention Agency;Cheongju: p. 1–272.
10. Walsh KA, Jordan K, Clyne B, Rohde D, Drummond L, Byrne P, et al. 2020; SARS-CoV-2 detection, viral load and infectivity over the course of an infection. J Infect. 81:357–71. DOI: 10.1016/j.jinf.2020.06.067. PMID: 32615199. PMCID: PMC7323671.
Article
11. Singanayagam A, Patel M, Charlett A, Lopez Bernal J, Saliba V, Ellis J, et al. 2020; Duration of infectiousness and correlation with RT-PCR cycle threshold values in cases of COVID-19, England, January to May 2020. Euro Surveill. 25:2001483. DOI: 10.2807/1560-7917.ES.2020.25.32.2001483. PMID: 32794447. PMCID: PMC7427302.
Article
12. Sohn S, Hong K, Chun BC. 2021; Decreased seasonal influenza during the COVID-19 pandemic in temperate countries. Travel Med Infect Dis. 41:102057. DOI: 10.1016/j.tmaid.2021.102057. PMID: 33836237. PMCID: PMC8022512.
Article
13. Dinnes J, Deeks JJ, Berhane S, Taylor M, Adriano A, Davenport C, et al. 2021; Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 3:CD013705. DOI: 10.1002/14651858.CD013705. PMID: 32845525. PMCID: PMC8078202.
Article
14. Inchon airport COVID-19 laboratory center. COVID-19 free airport. https://www.airport.kr/ap_cnt/ko/svc/covid19/medical/medical.do . Updated on 20 September 2021.
15. Canadian Public Health Laboratory Network. 2020; Interim guidance on the use of the Abbott ID NOWTM instrument and COVID-19 assay. Can Commun Dis Rep. 46:422–6. DOI: 10.14745/ccdr.v46i1112a09.
16. Tang YW, Schmitz JE, Persing DH, Stratton CW. 2020; Laboratory diagnosis of COVID-19: current issues and challenges. J Clin Microbiol. 58:e00512–20. DOI: 10.1128/JCM.00512-20. PMID: 32245835. PMCID: PMC7269383.
Article
17. Korean Society for Laboratory Medicine COVID-19 response task force. 2020. Guidelines for the laboratory diagnosis of COVID-19 in Korea. 4th ed. Korean Society for Laboratory Medicine;Seoul: p. 1–30.
18. Loeffelholz MJ, Alland D, Butler-Wu SM, Pandey U, Perno CF, Nava A, et al. 2020; Multicenter evaluation of the Cepheid Xpert Xpress SARS-CoV-2 test. J Clin Microbiol. 58:e00926–20. DOI: 10.1128/JCM.00926-20. PMID: 32366669. PMCID: PMC7383535.
Article
19. Farfour E, Asso-Bonnet M, Vasse M. SARS-CoV-2 Foch Hospital study group. 2021; The ID NOW COVID-19, a high-speed high-performance assay. Eur J Clin Microbiol Infect Dis. 40:2041–5. DOI: 10.1007/s10096-021-04243-0. PMID: 33855651. PMCID: PMC8046641.
Article
20. Hansen G, Marino J, Wang ZX, Beavis KG, Rodrigo J, Labog K, et al. 2021; Clinical performance of the point-of-care cobas Liat for detection of SARS-CoV-2 in 20 minutes: a multicenter study. J Clin Microbiol. 59:e02811–20. DOI: 10.1128/JCM.02811-20. PMID: 33239382. PMCID: PMC8111162.
Article
21. Kim SY, Lee J, Sung H, Lee H, Han MG, Yoo CK, et al. 2020; Pooling upper respiratory specimens for rapid mass screening of COVID-19 by real-time RT-PCR. Emerg Infect Dis. 26:2469–72. DOI: 10.3201/eid2610.201955. PMID: 32844739. PMCID: PMC7510748.
Article
22. Kumar KSR, Mufti SS, Sarathy V, Hazarika D, Naik R. 2021; An update on advances in COVID-19 laboratory diagnosis and testing guidelines in India. Front Public Health. 9:568603. DOI: 10.3389/fpubh.2021.568603. PMID: 33748054. PMCID: PMC7969786.
Article
23. COVID-19 Central Disaster Management Headquarters. 임시 선별 검사소 1개월 운영 결과, 3,301명 환자 발견 (20.12.14-‘21.1.13) [Detection of 3,301 cases for one month by temporary screening test center (20.12.14-‘21.1.13)]. http://ncov.mohw.go.kr/tcmBoardView.do?brdId=&brdGubun=&dataGubun=&ncvContSeq=363023&contSeq=363023&board_id=&gubun=ALL . Updated on 13 January 2021.
24. Jung J, Kim MN, Kim SH. 2020; Universal screening with sample pooling in preoperative patients as long-term strategy in the COVID-19 pandemic. J Korean Med Sci. 35:e309. DOI: 10.3346/jkms.2020.35.e309. PMID: 32830470. PMCID: PMC7445309.
Article
25. Centers for Disease Control. Interim guidance for use of pooling procedures in SARS-CoV-2 diagnostic and screening testing. https://www.cdc.gov/coronavirus/2019-ncov/lab/pooling-procedures.html . Updated on 30 June 2021.
26. Levine-Tiefenbrun M, Yelin I, Katz R, Herzel E, Golan Z, Schreiber L, et al. 2021; Initial report of decreased SARS-CoV-2 viral load after inoculation with the BNT162b2 vaccine. Nat Med. 27:790–2. DOI: 10.1038/s41591-021-01316-7. PMID: 33782619.
Article
27. Long QX, Liu BZ, Deng HJ, Wu GC, Deng K, Chen YK, et al. 2020; Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. 26:845–8. DOI: 10.1038/s41591-020-0897-1. PMID: 32350462.
28. Deeks JJ, Dinnes J, Takwoingi Y, Davenport C, Spijker R, Taylor-Phillips S, et al. 2020; Antibody tests for identification of current and past infection with SARS-CoV-2. Cochrane Database Syst Rev. 6:CD013652. DOI: 10.1002/14651858.CD013652. PMID: 32584464. PMCID: PMC7387103.
Article
29. Post N, Eddy D, Huntley C, van Schalkwyk MCI, Shrotri M, Leeman D, et al. 2020; Antibody response to SARS-CoV-2 infection in humans: a systematic review. PLoS One. 15:e0244126. DOI: 10.1371/journal.pone.0244126. PMID: 33382764. PMCID: PMC7775097.
Article
30. Centers for Disease Control. Interim guidelines for COVID-19 antibody testing. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antibody-tests-guidelines.html . Updated on 21 September 2021.
31. Scohy A, Anantharajah A, Bodéus M, Kabamba-Mukadi B, Verroken A, Rodriguez-Villalobos H. 2020; Low performance of rapid antigen detection test as frontline testing for COVID-19 diagnosis. J Clin Virol. 129:104455. DOI: 10.1016/j.jcv.2020.104455. PMID: 32485618. PMCID: PMC7240272.
Article
32. Korean Society of Epidemiology. 신속항원검사를 활용한 코로나19 선별검사에 대한 한국역학회의 입장[Opinion of Korean Society of Epidemiology on COVID-19 screening using rapid antigen test]. http://www.ksepi.org/web/lay1/bbs/S1T298C327/A/11/view.do?article_seq=2159&cpage=&rows=&condition=&keyword= . Updated on 27 December 2020.
33. Oh SM, Jeong H, Chang E, Choe PG, Kang CK, Park WB, et al. 2021; Clinical application of the Standard Q COVID-19 Ag test for the detection of SARS-CoV-2 infection. J Korean Med Sci. 36:e101. DOI: 10.3346/jkms.2021.36.e101. PMID: 33847084. PMCID: PMC8042480.
Article
34. Ministry of Food. 식약처, 조건부 허가 자가검사키트 2개 정식 품목허가[Authorization of conditionally used two home test kits by Ministry of Food and Drug Safety]. https://www.mfds.go.kr/brd/m_99/view.do?seq=45656&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=1 . Updated on 13 August 2021.
35. Ministry of Food. 2021. April. 16. 「체외진단의료기기 허가·신고·심사 등에 관한 규정」 일부개정고시. 제2021-34호[Partial revision of regulations on approval, report, and review for in vitro diagnostic test kits. No. 2021-34].
36. Corman VM, Haage VC, Bleicker T, Schmidt ML, Mühlemann B, Zuchowski M, et al. 2021; Comparison of seven commercial SARS-CoV-2 rapid point-of-care antigen tests: a single-centre laboratory evaluation study. Lancet Microbe. 2:e311–9. DOI: 10.1016/S2666-5247(21)00056-2. PMID: 33846704. PMCID: PMC8026170.
Article
37. Pharmaceutical Safety Division. 2020. [Approval of diagnostic test for SARS-CoV-2 infection (Lumipulse G SARS-CoV-2 Ag)]. Pharmaceutical Safety Division, Ministry of Health, Labor and Welfare;Tokyo: p. 1–4. Japanese.
38. Menchinelli G, Bordi L, Liotti FM, Palucci I, Capobianchi MR, Sberna G, et al. 2021; Lumipulse G SARS-CoV-2 Ag assay evaluation using clinical samples from different testing groups. Clin Chem Lab Med. 59:1468–76. DOI: 10.1515/cclm-2021-0182. PMID: 33823089.
Article
39. Ogawa T, Fukumori T, Nishihara Y, Sekine T, Okuda N, Nishimura T, et al. 2020; Another false-positive problem for a SARS-CoV-2 antigen test in Japan. J Clin Virol. 131:104612. DOI: 10.1016/j.jcv.2020.104612. PMID: 32871543. PMCID: PMC7445490.
Article
40. Yokota I, Hattori T, Shane PY, Konno S, Nagasaka A, Takeyabu K, et al. 2021; Equivalent SARS-CoV-2 viral loads by PCR between nasopharyngeal swab and saliva in symptomatic patients. Sci Rep. 11:4500. DOI: 10.1038/s41598-021-84059-2. PMID: 33627730. PMCID: PMC7904914.
Article
41. Atieh MA, Guirguis M, Alsabeeha NHM, Cannon RD. in press 2021; The diagnostic accuracy of saliva testing for SARS-CoV-2: a systematic review and meta-analysis. Oral Dis. DOI: 10.1111/odi.13934. PMID: 34080272. PMCID: PMC8242702.
Article
42. Butler-Laporte G, Lawandi A, Schiller I, Yao M, Dendukuri N, McDonald EG, et al. 2021; Comparison of saliva and nasopharyngeal swab nucleic acid amplification testing for detection of SARS-CoV-2: a systematic review and meta-analysis. JAMA Intern Med. 181:353–60. DOI: 10.1001/jamainternmed.2020.8876. PMID: 33449069. PMCID: PMC7811189.
43. Barat B, Das S, De Giorgi V, Henderson DK, Kopka S, Lau AF, et al. 2021; Pooled saliva specimens for SARS-CoV-2 testing. J Clin Microbiol. 59:e02486–20. DOI: 10.1128/JCM.02486-20. PMID: 33262219. PMCID: PMC8106731.
Article
44. Centers for Disease Control. Overview of testing for SARS-CoV-2 (COVID-19). https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html . Updated on 22 October 2021.
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