과제정보
This research was supported by Hyejeon College grant.
참고문헌
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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?fn=20220503062003939.pdf&rs=/docviewer/result/ntc0003/44348/2/202205
- 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
- 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
- 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
- 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
- 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
- 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
- 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 https://doi.org/10.1016/j.aca.2018.10.054
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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