$\require{mediawiki-texvc}$

연합인증

연합인증 가입 기관의 연구자들은 소속기관의 인증정보(ID와 암호)를 이용해 다른 대학, 연구기관, 서비스 공급자의 다양한 온라인 자원과 연구 데이터를 이용할 수 있습니다.

이는 여행자가 자국에서 발행 받은 여권으로 세계 각국을 자유롭게 여행할 수 있는 것과 같습니다.

연합인증으로 이용이 가능한 서비스는 NTIS, DataON, Edison, Kafe, Webinar 등이 있습니다.

한번의 인증절차만으로 연합인증 가입 서비스에 추가 로그인 없이 이용이 가능합니다.

다만, 연합인증을 위해서는 최초 1회만 인증 절차가 필요합니다. (회원이 아닐 경우 회원 가입이 필요합니다.)

연합인증 절차는 다음과 같습니다.

최초이용시에는
ScienceON에 로그인 → 연합인증 서비스 접속 → 로그인 (본인 확인 또는 회원가입) → 서비스 이용

그 이후에는
ScienceON 로그인 → 연합인증 서비스 접속 → 서비스 이용

연합인증을 활용하시면 KISTI가 제공하는 다양한 서비스를 편리하게 이용하실 수 있습니다.

SARS-CoV-2 감염의 진단에 이용되는 검사실 테스트의 비교
Comparison of Laboratory Tests Applied for Diagnosing the SARS-CoV-2 Infection 원문보기

Korean journal of clinical laboratory science : KJCLS = 대한임상검사과학회지, v.54 no.2, 2022년, pp.79 - 94  

이창근 (아주대학교 의과대학 의학유전학과) ,  이동섭 (혜전대학교 임상병리과)

초록
AI-Helper 아이콘AI-Helper

COVID-19로 인한 높은 전염성과 호흡기 질환의 심각성 때문에, 전염의 확산을 더 잘 모니터링하고 예방하기 위해 경제적이고 정확한 검사가 필요하다. COVID-19 대유행의 초기 단계에서 SARS-CoV-2의 구조적 및 분자적 특성이 밝혀짐에 따라, 많은 COVID-19 진단 키트 제조업체들은 진단 테스트의 설계, 개발, 검증 및 구현에 적극적으로 투자했다. 현재, SARS-CoV-2에 대한 진단검사로써 신속한 항원, 특정 IgG 및 IgM 항체검사를 위한 면역 혈청학적 검사 그리고 분자 진단 검사가 가장 널리 사용되고 검증된 기술이다. 분자 진단 분석법은 SARS-CoV-2에 감염된 것으로 의심되는 개인에서 바이러스 RNA를 직접 검출하기 위한 gold standard이다. 항체 기반 혈청 검사는 지역사회에서 COVID-19 유병률을 결정하고 면역력을 획득한 개인을 식별하는 데 사용되는 간접 검사이다. 본 논문에서는 시판되고 FDA가 승인한 분자 및 면역학적 진단 측정을 평가하여 성능 특성을 분석하였다.

Abstract AI-Helper 아이콘AI-Helper

Due to the highly contagious nature and severity of the respiratory diseases caused by COVID-19, economical and accurate tests are required to better monitor and prevent the spread of this contagion. As the structural and molecular properties of SARS-CoV-2 were being revealed during the early stage ...

주제어

표/그림 (10)

참고문헌 (60)

  1. Kim EJ, Lee D. Coronaviruses: SARS, MERS and COVID-19. Korean J Clin Lab Sci. 2020;52:297-309. https://doi.org/10.15324/kjcls.2020.52.4.297 

  2. Yang BS, Choi SM, Bae HJ, Kim YS, Lim Y, Kang HJ, et al. The role and focus areas of medical technologists in the field of diagnostic tests in the COVID-19 era. Korean J Clin Lab Sci. 2022;54:49-60. https://doi.org/10.15324/kjcls.2022.54.1.49 

  3. Habli Z, Saleh S, Zaraket H, Khraiche ML. COVID-19 in-vitro diagnostics: state-of-the-art and challenges for rapid, scalable, and high-accuracy screening. Front Bioeng Biotechnol. 2021;8:1-14. https://doi.org/10.3389/fbioe.2020.605702 

  4. Ravi N, Cortade DL, Ng E, Wang SX. Diagnostics for SARS-CoV-2 detection: A comprehensive review of the FDA-EUA COVID-19 testing landscape. Biosens Bioelectron. 2020;165:112454. https://doi.org/10.1016/j.bios.2020.112454 

  5. Hu B, Guo H, Zhou P, Shi ZL. Characteristics of SARS-CoV-2 and COVID-19. Nat Rev Microbiol. 2020:1-14. https://doi.org/10.1038/s41579-020-00459-7 

  6. Lu R, Zhao X, Li J, Niu P, Yang B, Wu H, et al. Genomic characterization and epidemiology of 2019 novel coronavirus: Implications for virus origins and receptor binding. Lancet. 2020;395:565-574. https://doi.org/10.1016/S0140-6736(20)30251-8 

  7. Diaz DA, Munoz CF, Donato KL, Ciro JU, Sierra NF, Sanchez AF, et al. Molecular analysis of several in-house rRT-PCR protocols for SARS-CoV-2 detection in the context of genetic variability of the virus in Colombia. Infect Genet Evol. 2020;84:104390. https://doi.org/10.1016/j.meegid.2020.104390 

  8. Falzone L, Gattuso G, Tsatsakis A, Spandidos DA, Libra M. Current and innovative methods for the diagnosis of COVID-19 infection (Review). Int J Mol Med. 2021;47:100. https://doi.org/10.3892/ijmm.2021.4933 

  9. Lang FM, Lee KM, Teijaro JR, Becher B, Hamilton JA. GM-CSF-based treatments in COVID-19: Reconciling opposing therapeutic approaches. Nat Rev Immunol. 2020;20:507-514. https://doi.org/10.1038/s41577-020-0357-7 

  10. Rong G, Zheng Y, Chen Y, Zhang Y, Zhu P, Sawana M. COVID-19 diagnostic methods and detection techniques: A review. Reference Module in Biomedical Sciences. 2021:B978-0-12-822548-6.00080-7. https://doi.org/10.1016/B978-0-12-822548-6.00080-7 

  11. Zhang Y, Wang C, Han M, Ye J, Gao Y, Liu Z, et al. Discrimination of false negative results in RT-PCR detection of SARS-CoV-2 RNAs in clinical specimens by using an internal reference. Virol Sin. 2020;35:758-767. https://doi.org/10.1007/s12250-020-00273-8 

  12. Jacofsky D, Jacofsky EM, Jacofsky M. Understanding antibody testing for COVID-19. J Arthroplasty. 2020;35:S74-S81. https://doi.org/10.1016/j.arth.2020.04.055 

  13. To KW, Tsang OY, Leung WS, Tam AR, Wu TC, Lung DC, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: An observational cohort study. Lancet Infect Dis. 2020;20:565-574. https://doi.org/10.1016/S1473-3099(20)30196-1 

  14. Tan W, Lu Y, Zhang J, Wang J, Dan Y, Tan Z, et al. Viral kinetics and antibody responses in patients with COVID-19. medRxiv. 2020. https://doi.org/10.1101/2020.03.24.20042382 

  15. Renard N, Daniel S, Cayet N, Pecquet M, Raymond F, Pons S, et al. Performance characteristics of the vidas SARS-CoV-2 IgM and IgG serological assays. J Clin Microbiol. 2021;59:e02292-20. https://doi.org/10.1128/JCM.02292-20 

  16. Demey B, Daher N, Francois C, Lanoix JP, Duverlie G, Castelain S, et al. Dynamic profile for the detection of anti-SARS-CoV-2 antibodies using four immunochromatographic assays. J Infect. 2020;81:e6-e10. https://doi.org/10.1016/j.jinf.2020.04.033 

  17. Hsieh WY, Lin CH, Lin TC, Lin CH, Chang HF, Tsai CH, et al. Development and efficacy of lateral flow point-of-care testing devices for rapid and mass COVID-19 diagnosis by the detections of SARS-CoV-2 antigen and anti-SARS-CoV-2 antibodies. Diagnostics. 2021;11:1760. https://doi.org/10.3390/diagnostics11101760 

  18. Tali SS, LeBlanc JJ, Sadiq Z, Oyewunmi OD, Camargo C, Nikpour B, et al. Tools and techniques for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)/COVID-19 detection. ASM Journals. 2021;34:e00228-20. https://doi.org/10.1128/CMR.00228-20 

  19. Song GS, Lee YR, Kim S, Kim W, Choi J, Yoo D, et al. Laboratory diagnosis of coronavirus disease 19 (COVID-19) in Korea: Current status, limitation, and challenges. Korean J Clin Lab Sci. 2020;52:284-295. https://doi.org/10.15324/kjcls.2020.52.3.284 

  20. Toropov N, Osborne E, Joshi LT, Davidson J, Morgan C, Page J, et al. SARS-CoV-2 tests: Bridging the gap between laboratory sensors and clinical applications. ACS Sens. 2021;6:2815-2837. https://doi.org/10.1021/acssensors.1c00612 

  21. Kevadiya BD, Machhi J, Herskovitz J, Oleynikov MD, Blomberg WR, Bajwa N, et al. Diagnostics for SARS-CoV-2 infections. Nat Mater. 2021;20:593-605. https://doi.org/10.1038/s41563-020-00906-z 

  22. Younes N, Sadeq DW, Jighefee HA, Younes S, Jamal OA, Daas HI, et al. Challenges in laboratory diagnosis of the novel coronavirus SARS-CoV-2. Viruses. 2020;12:582. https://doi.org/10.3390/v12060582 

  23. Udugama B, Kadhiresan P, Kozlowski HN, Malekjahani A, Osborne M, Li VC, et al. Diagnosing COVID-19: The disease and tools for detection. ACS Nano. 2020:acsnano.0c02624. https://doi.org/10.1021/acsnano.0c02624 

  24. Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, et al. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020;395:497-506. https://doi.org/10.1016/S0140-6736(20)30183-5 

  25. List of COVID-19 diagnostic devices approved by MFDS [Internet]. Osong: Ministry of Food and Drug Safety; 2022 [cited 2022 May 5]. Available from: https://www.mfds.go.kr/docviewer/skin/doc.html?fn20220503062003939.pdf&rs/docviewer/result/ntc0003/44348/2/202205 

  26. Dinnes J, Deeks JJ, Adriano A, Berhane S, Davenport C, Dittrich S, et al. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 2020;8:CD013705. https://doi.org/10.1002/14651858.CD013705 

  27. James AS, Alwneh JI. COVID-19 Infection diagnosis: Potential impact of isothermal amplification technology to reduce community transmission of SARS-CoV-2. Diagnostics. 2020;10:399. https://doi.org/10.3390/diagnostics10060399 

  28. Li J, Macdonald J, von Stetten F. Review: A comprehensive summary of a decade development of the recombinase polymerase amplification. Analyst. 2018;144:31-67. https://doi.org/10.1039/c8an01621f 

  29. Lau YL, Ismail IB, Mustapa NB, Lai MY, Soh TT, Hassan AH, et al. Development of a reverse transcription recombinase polymerase amplification assay for rapid and direct visual detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). PLoS One. 2021;16:e0245164. https://doi.org/10.1371/journal.pone.0245164 

  30. Behrmann O, Bachmann I, Spiegel M, Schramm M, Wahed AE, Dobler G, et al. Rapid detection of SARS-CoV-2 by low volume real-time single tube reverse transcription recombinase polymerase amplification using an exo probe with an internally linked quencher (Exo-IQ). Clin Chem. 2020;66:1047-1054. https://doi.org/10.1093/clinchem/hvaa116 

  31. Smith E, Zhen W, Manji R, Schron D, Duong S, Berry GJ. Analytical and clinical comparison of three nucleic acid amplification tests for SARS-CoV-2 detection. J Clin Microbiol. 2020;58:e01134-20. https://doi.org/10.1128/JCM.01134-20 

  32. Qian C, Wang R, Wu H, Ji F, Wu J. Nicking enzyme-assisted amplification (NEAA) technology and its applications: A review. Anal Chim Acta. 2019;1050:1-15. https://doi.org/0.1016/j.aca.2018.10.054 

  33. Alves PA, de Oliveira EG, Luiz AF, Almeida LT, Goncalves AB, Borges IA, et al. Optimization and clinical validation of colorimetric reverse transcription loop-mediated isothermal amplification, a fast, highly sensitive and specific COVID-19 molecular diagnostic tool that is robust to detect SARS-CoV-2 variants of concern. Front Microbiol. 2021;12:713713. https://doi.org/10.3389/fmicb.2021.713713 

  34. Moore KM, Cahill J, Aidelberg G, Aronoff R, Bektas A, Bezdan D, et al. Loop-Mediated isothermal amplification detection of SARS-CoV-2 and myriad other applications. J Biomol Tech. 2021;32:228-275. https://doi.org/10.7171/jbt.21-3203-017 

  35. Lee CJ, Shin WS, Mun SY, Yu MJ, Choi YB, Kim DH, et al. Diagnostic evaluation of qRT-PCR-based kit and dPCR-based kit for COVID-19. Genes Genomics. 2021;43:1277-1288. https://doi.org/10.1007/s13258-021-01162-4 

  36. Ali Z, Aman R, Mahas A, Rao GS, Tehseen M, Marsic T, et al. iSCAN: An RT-LAMP-coupled CRISPR-Cas12 module for rapid, sensitive detection of SARS-CoV-2. Virus Res. 2020;288:198129. https://doi.org/10.1016/j.virusres.2020.198129 

  37. Guo L, Sun X, Wang X, Liang C, Jiang H, Gao Q, et al. SARS-CoV-2 detection with CRISPR diagnostics. Cell Discov. 2020;6:34. https://doi.org/10.1038/s41421-020-0174-y 

  38. Hess JF, Kohl TA, Kotrova M, Ronsch K, Paprotka T, Mohr V, et al. Library preparation for next generation sequencing: A review of automation strategies. Biotechnol Adv. 2020;41:107537. https://doi.org/10.1016/j.biotechadv.2020.107537 

  39. Bhoyar RC, Jain A, Sehgal P, Divakar MK, Sharma D, Imran M, et al. High throughput detection and genetic epidemiology of SARS-CoV-2 using COVIDSeq next-generation sequencing. PLoS One. 2021;16:e0247115. https://doi.org/10.1371/journal.pone.0247115 

  40. Bloom JS, Sathe L, Munugala C, Jones EM, Gasperini M, Lubock NB, et al. Swab-Seq: A high-throughput platform for massively scaled up SARS-CoV-2 testing. medRxiv. 2020:20167874. https://doi.org/10.1101/2020.08.04.20167874 

  41. Hilaire BS, Durand NC, Mitra N, Pulido SG, Mahajan R, Blackburn A, et al. A rapid, low cost, and highly sensitive SARS-CoV-2 diagnostic based on whole genome sequencing. bioRxiv. 2020:061499. https://doi.org/10.1101/2020.04.25.061499 

  42. Jary A, Leducq V, Malet I, Marot S, Frutos EK, Teyssou E, et al. Evolution of viral quasispecies during SARS-CoV-2 infection. Clin Microbiol Infect. 2020;26:1560.e1-1560.e4. https://doi.org/10.1016/j.cmi.2020.07.032 

  43. Mak GK, Lau SY, Wong KY, Chow NS, Lau CS, Lam EK, et al. Evaluation of rapid antigen detection kit from the WHO emergency use list for detecting SARS-CoV-2. J Clin Virol. 2021;134:104712. https://doi.org/10.1016/j.jcv.2020.104712 

  44. Interim guidance of World Health Organization, Antigen-Detection in the diagnosis of SARS-CoV-2 infection using rapid immunoassays interim guidance [Internet]. Geneva: World Health Organization; 2021 [cited 2021 October 6]. Available from: https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays 

  45. Yun SG, Ko DH, Kim YE, Roh KH, Lee JH, Cho JH, et al. Initial response of the Korean society for laboratory medicine to the COVID-19 pandemic. Lab Med Online. 2021;11:217-222. https://doi.org/10.47429/lmo.2021.11.4.217 

  46. Mak GK, Cheng PC, Lau SY, Wong KY, Lau CS, Lam ET, et al. Evaluation of rapid antigen test for detection of SARS-CoV-2 virus. J Clin Virol. 2020;129:104500. https://doi.org/10.1016/j.jcv.2020.104500 

  47. Yadav S, Sadique MA, Ranjan P, Kumar N, Singhal A, Srivastava AK, et al. SERS based lateral flow immunoassay for point-of-care detection of SARS-CoV-2 in clinical samples. ACS Appl Bio Mater. 2021;4:2974-2995. https://doi.org/10.1021/acsabm.1c00102 

  48. Liotti FM, Menchinelli G, Lalle E, Palucci I, Marchetti S, Colavita F, et al. Performance of a novel diagnostic assay for rapid SARS-CoV-2 antigen detection in nasopharynx samples. Clin Microbiol Infect. 2021;27:487-488. https://doi.org/10.1016/j.cmi.2020.09.030 

  49. Korenkov M, Poopalasingam N, Madler M, Vanshylla K, Eggeling R, Wirtz M, et al. Evaluation of a rapid antigen test to detect SARS-CoV-2 infection and identify potentially infectious individuals. J Clin Microbiol. 2021;59:e00896-21. https://doi.org/10.1128/JCM.00896-21 

  50. Sun B, Feng Y, Mo X, Zheng P, Wang Q, Li P, et al. Kinetics of SARS-CoV-2 specific IgM and IgG responses in COVID-19 patients. Emerg Microbes Infect. 2020;9:940-948. https://doi.org/10.1080/22221751.2020.1762515 

  51. Espejo AP, Akgun Y, Mana AA, Tjendra Y, Millan NC, Fernandez CG, et al. Review of current advances in serologic testing for COVID-19. Am J Clin Pathol. 2020;154:293-304. https://doi.org/10.1093/ajcp/aqaa112 

  52. Filchakova O, Dossym D, Ilyas A, Kuanysheva T, Abdizhamil A, Bukasov R. Review of COVID-19 testing and diagnostic methods. Talanta. 2022;244:123409. https://doi.org/10.1016/j.talanta.2022.123409 

  53. Alpdagtas S, Ilhan E, Uysal E, Sengor M, Ustundag CB, Gunduz O. Evaluation of current diagnostic methods for COVID-19. APL Bioeng. 2020;4:041506. https://doi.org/10.1063/5.0021554 

  54. Burbelo PD, Riedo FX, Morishima C, Rawlings S, Smith D, Das S, et al. Detection of nucleocapsid antibody to SARS-CoV-2 is more sensitive than antibody to spike protein in COVID-19 patients. medRxiv. 2020:20071423. https://doi.org/10.1101/2020.04.20.20071423 

  55. Deeks JJ, Dinnes J, Takwoingi Y, Davenport C, Spijker R, Taylor-Phillips S, et al. Antibody tests for identification of current and past infection with SARS-CoV-2. Cochrane Database Syst Rev. 2020;6:CD013652. https://doi.org/10.1002/14651858.CD013652 

  56. Norman M, Gilboa T, Ogata AF, Maley AM, Cohen L, Cai Y, et al. Ultra-sensitive high-resolution profiling of anti-SARS-CoV-2 antibodies for detecting early seroconversion in COVID-19 patients. medRxiv. 2020:20083691. https://doi.org/10.1101/2020.04.28.20083691 

  57. Choi DO, Lee KM. Development of COVID-19 neutralizing antibody (NAb) detection kits using the S1 RBD protein of SARS-CoV-2. Korean J Clin Lab Sci. 2021;53:257-265. https://doi.org/10.15324/kjcls.2021.53.3.257 

  58. Vandenberg O, Martiny D, Rochas O, van Belkum A, Kozlakidis Z. Considerations for diagnostic COVID-19 tests. Nat Rev Microbiol. 2021;19:171-183. https://doi.org/10.1038/s41579-020-00461-z 

  59. Ghaffari A, McGill I, Ardakani A. Trends in COVID-19 diagnostic test development [Internet]. Bioprocess Int. 2020 [cited 2020 June 11]. Available from: https://bioprocessintl.com/analytical/diagnostics/trends-in-development-of-covid-19-diagnostic-tests 

  60. Carter LJ, Garner LV, Smoot JW, Li Y, Zhou Q, Saveson CJ, et al. Assay techniques and test development for COVID-19 diagnosis. ACS Cent Sci. 2020;6:591-605. https://doi.org/10.1021/acscentsci.0c00501 

저자의 다른 논문 :

관련 콘텐츠

오픈액세스(OA) 유형

GOLD

오픈액세스 학술지에 출판된 논문

이 논문과 함께 이용한 콘텐츠

저작권 관리 안내
섹션별 컨텐츠 바로가기

AI-Helper ※ AI-Helper는 오픈소스 모델을 사용합니다.

AI-Helper 아이콘
AI-Helper
안녕하세요, AI-Helper입니다. 좌측 "선택된 텍스트"에서 텍스트를 선택하여 요약, 번역, 용어설명을 실행하세요.
※ AI-Helper는 부적절한 답변을 할 수 있습니다.

선택된 텍스트

맨위로