Mini review Topical Sections

An update on lateral flow immunoassay for the rapid detection of SARS-CoV-2 antibodies

  • Received: 01 November 2022 Revised: 31 March 2023 Accepted: 04 April 2023 Published: 13 April 2023
  • Over the last three years, after the outbreak of the COVID-19 pandemic, an unprecedented number of novel diagnostic tests have been developed. Assays to evaluate the immune response to SARS-CoV-2 have been widely considered as part of the control strategy. The lateral flow immunoassay (LFIA), to detect both IgM and IgG against SARS-CoV-2, has been widely studied as a point-of-care (POC) test. Compared to laboratory tests, LFIAs are faster, cheaper and user-friendly, thus available also in areas with low economic resources. Soon after the onset of the pandemic, numerous kits for rapid antibody detection were put on the market with an emergency use authorization. However, since then, scientists have tried to better define the accuracy of these tests and their usefulness in different contexts. In fact, while during the first phase of the pandemic LFIAs for antibody detection were auxiliary to molecular tests for the diagnosis of COVID-19, successively these tests became a tool of seroprevalence surveillance to address infection control policies. When in 2021 a massive vaccination campaign was implemented worldwide, the interest in LFIA reemerged due to the need to establish the extent and the longevity of immunization in the vaccinated population and to establish priorities to guide health policies in low-income countries with limited access to vaccines. Here, we summarize the accuracy, the advantages and limits of LFIAs as POC tests for antibody detection, highlighting the efforts that have been made to improve this technology over the last few years.

    Citation: Lucia Spicuzza, Davide Campagna, Chiara Di Maria, Enrico Sciacca, Salvatore Mancuso, Carlo Vancheri, Gianluca Sambataro. An update on lateral flow immunoassay for the rapid detection of SARS-CoV-2 antibodies[J]. AIMS Microbiology, 2023, 9(2): 375-401. doi: 10.3934/microbiol.2023020

    Related Papers:

  • Over the last three years, after the outbreak of the COVID-19 pandemic, an unprecedented number of novel diagnostic tests have been developed. Assays to evaluate the immune response to SARS-CoV-2 have been widely considered as part of the control strategy. The lateral flow immunoassay (LFIA), to detect both IgM and IgG against SARS-CoV-2, has been widely studied as a point-of-care (POC) test. Compared to laboratory tests, LFIAs are faster, cheaper and user-friendly, thus available also in areas with low economic resources. Soon after the onset of the pandemic, numerous kits for rapid antibody detection were put on the market with an emergency use authorization. However, since then, scientists have tried to better define the accuracy of these tests and their usefulness in different contexts. In fact, while during the first phase of the pandemic LFIAs for antibody detection were auxiliary to molecular tests for the diagnosis of COVID-19, successively these tests became a tool of seroprevalence surveillance to address infection control policies. When in 2021 a massive vaccination campaign was implemented worldwide, the interest in LFIA reemerged due to the need to establish the extent and the longevity of immunization in the vaccinated population and to establish priorities to guide health policies in low-income countries with limited access to vaccines. Here, we summarize the accuracy, the advantages and limits of LFIAs as POC tests for antibody detection, highlighting the efforts that have been made to improve this technology over the last few years.



    加载中


    Conflict of interest



    All authors declare no conflicts of interest in this paper.

    [1] Eriksson E, Lysell J, Larsson H, et al. (2019) Geometric flow control lateral flow immunoassay devices (GFC-LFIDs): a new dimension to enhance analytical performance. Research . https://doi.org/10.34133/2019/8079561
    [2] Peeling RW, Wedderburn CJ, Garcia PJ, et al. (2020) Serology testing in the COVID-19 pandemic response. Lancet Infect Dis 20: e245-e249. https://doi.org/10.1016/S1473-3099(20)30517-X
    [3] Mathieu E, Ritchie H, Rodés-Guirao L, et al. Coronavirus Pandemic (COVID-19) (2020). Available from: https://ourworldindata.org/coronavirus
    [4] World Health OrganizationDiagnostic testing for SARS-CoV-2 (2020). Available from: https://www.who.int/publications/i/item/diagnostic-testing-for-sars-cov-2
    [5] (2022) European Centre for Disease Prevention and ControlConsiderations for the use of antibody tests for SARSCoV-2 – first update. Stockholm: ECDC.
    [6] Chisale MRO, Ramazanu S, Mwale SE, et al. (2022) Seroprevalence of anti-SARS-CoV-2 antibodies in Africa: a systematic review and meta-analysis. Rev Med Virol 32: e2271. https://doi.org/10.1002/rmv.2271
    [7] Mirica AC, Stan D, Chelcea IC, et al. (2022) Latest trends in lateral flow immunoassay (LFIA) detection labels and conjugation process. Front Bioeng Biotechnol 14: 922772. https://doi.org/10.3389/fbioe.2022.922772
    [8] Kosack CS, Page AL, Klatser PR, et al. (2017) A guide to aid the selection of diagnostic tests. Bull World Health Organ 95: 639-645. https://doi.org/10.2471/BLT.16.187468
    [9] Kumar M, Iyer SS (2021) ASSURED-SQVM diagnostics for COVID-19: addressing the why, when, where, who, what and how of testing. Expert Rev Mol Diagn 21: 349-362. https://doi.org/10.1080/14737159.2021.1902311
    [10] Azkur AK, Akdis M, Azkur D, et al. (2020) Immune response to SARS-CoV-2 and mechanisms of immunopathological changes in COVID-19. Allergy 75: 1564-1581. https://doi.org/10.1111/all.14364
    [11] Guo L, Ren L, Yang S, et al. (2020) Profiling early humoral response to diagnose novel coronavirus disease (COVID-19). Clin Infect Dis 28: 778-785. https://doi.org/10.1093/cid/ciaa310
    [12] Wang Y, Zhang L, Sang L, et al. (2020) Kinetics of viral load and antibody response in relation to COVID-19 severity. J Clin Invest 130: 5235-5244. https://doi.org/10.1172/JCI138759
    [13] Herroelen PH, Martens GA, De Smet D, et al. (2020) Humoral immune response to SARS-CoV-2. Am J Clin Pathol 154: 610-619. https://doi.org/10.1093/ajcp/aqaa140
    [14] Huang AT, Garcia-Carreras B, Hitchings MDT, et al. (2020) A systematic review of antibody mediated immunity to coronaviruses: kinetics, correlates of protection, and association with severity. Nat Commun 11: 4704. https://doi.org/10.1038/s41467-020-18450-4
    [15] Spicuzza L, Montineri A, Manuele R, et al. (2020) Reliability and usefulness of a rapid IgM-IgG antibody test for the diagnosis of SARS-CoV-2 infection: a preliminary report. J Infect 81: e53-e54. https://doi.org/10.1016/j.jinf.2020.04.022
    [16] Padoan A, Sciacovelli L, Basso D (2020) IgA-Ab response to spike glycoprotein of SARS-CoV-2 in patients with COVID-19: A longitudinal study. Clin Chim Acta 507: 164-166. https://doi.org/10.1016/j.cca.2020.04.026
    [17] Zhang Y, Chai Y, Hu Z, et al. (2022) Recent progress on rapid lateral flow assay-based early diagnosis of COVID-19. Front Bioeng Biotechnol 10: 866368. https://doi.org/10.3389/fbioe.2022.866368
    [18] Vabret N, Britton GJ, Gruber C, et al. (2020) Immunology of COVID-19: current state of the science. Immunity 52: 910-941. https://doi.org/10.1016/j.immuni.2020.05.002
    [19] Zhao J, Yuan Q, Wang H, et al. (2020) Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis 71: 2027-2034. https://doi.org/10.1093/cid/ciaa344
    [20] Martín J, Tena N, Asuero AG, et al. (2021) Current state of diagnostic, screening and surveillance testing methods for COVID-19 from an analytical chemistry point of view. Microchem J 167: 106305. https://doi.org/10.1016/j.microc.2021.106305
    [21] Al-Tamimi M, Tarifi AA, Qaqish A, et al. (2023) Immunoglobulins response of COVID-19 patients, COVID-19 vaccine recipients, and random individuals. PLoS One 18: e0281689. https://doi.org/10.1371/journal.pone.0281689
    [22] Zhang S, Xu K, Li C, et al. (2022) Long-term kinetics of SARS-CoV-2 antibodies and impact of inactivated vaccine on SARS-CoV-2 antibodies based on a COVID-19 patients cohort. Front Immunol 13: 829665. https://doi.org/10.3389/fimmu.2022.829665
    [23] Liang Y, Wang ML, Chien CS, et al. (2020) Highlight of immune pathogenic response and hematopathologic effect in SARS-CoV, MERS-CoV, and SARS-Cov-2 infection. Front Immunol 11: 1022. https://doi.org/10.3389/fimmu.2020.01022
    [24] Irani S (2022) Immune responses in SARS-CoV-2, SARS-CoV, and MERS-CoV infections: a comparative review. Int J Prev Med 13: 45. https://doi.org/10.4103/ijpvm.IJPVM_429_20
    [25] Chiereghin A, Zagari RM, Galli S, et al. (2021) Recent advances in the evaluation of serological assays for the diagnosis of SARS-CoV-2 infection and COVID-19. Front Public Health 8: 620222. https://doi.org/10.3389/fpubh.2020.620222
    [26] Vengesai A, Midzi H, Kasambala M, et al. (2021) A systematic and meta-analysis review on the diagnostic accuracy of antibodies in the serological diagnosis of COVID-19. Syst Rev 10: 155. https://doi.org/10.1186/s13643-021-01689-3
    [27] Wang MY, Zhao R, Gao LJ, et al. (2020) Structure, biology, and structure-based therapeutics development. Front Cell Infect Microbiol 10: 587269. https://doi.org/10.3389/fcimb.2020.587269
    [28] Rak A, Donina S, Zabrodskaya Y, et al. (2022) Cross-reactivity of SARS-CoV-2 nucleocapsid-binding antibodies and its implication for COVID-19 serology tests. Viruses 14. https://doi.org/10.3390/v14092041
    [29] Wang JJ, Zhang N, Richardson SA, et al. (2021) Rapid lateral flow tests for the detection of SARS-CoV-2 neutralizing antibodies. Expert Rev Mol Diagn 21: 363-370. https://doi.org/10.1080/14737159.2021.1913123
    [30] Jalkanen P, Pasternack A, Maljanen S, et al. (2021) A combination of N and S antigens with IgA and IgG measurement strengthens the accuracy of SARS-CoV-2 serodiagnostics. J Infect Dis 224: 218-228. https://doi.org/10.1093/infdis/jiab222
    [31] Gong F, Wei HX, Li Q, et al. (2021) Evaluation and comparison of serological methods for COVID-19 diagnosis. Front Mol Biosci 8: 682405. https://doi.org/10.3389/fmolb.2021.682405
    [32] Yadegari H, Mohammadi M, Maghsood F, et al. (2023) Diagnostic performance of a novel antigen-capture ELISA for the detection of SARS-CoV-2. Anal Biochem 666: 115079. https://doi.org/10.1016/j.ab.2023.115079
    [33] Guarino C, Larson E, Babasyan S, et al. (2022) Development of a quantitative COVID-19 multiplex assay and its use for serological surveillance in a low SARS-CoV-2 incidence community. PLoS One 17: e0262868. https://doi.org/10.1371/journal.pone.0262868
    [34] Amanat F, Stadlbauer D, Strohmeier S, et al. (2020) A serological assay to detect SARS-CoV-2 seroconversion in humans. Nature Medicine 26: 1033-1036. https://doi.org/10.1038/s41591-020-0913-5
    [35] Ravi N, Cortade DL, Ng E, et al. (2020) Diagnostics for SARS-CoV-2 detection: a comprehensive review of the FDA-EUA COVID-19 testing landscape. Biosens Bioelectron 165: 112454. https://doi.org/10.1016/j.bios.2020.112454
    [36] Okba NMA, Müller MA, Li W, et al. (2020) Severe acute respiratory syndrome coronavirus 2-specific antibody responses in coronavirus disease patients. Emerg Infect Dis 26: 1478-1488. https://doi.org/10.3201/eid2607.200841
    [37] Ghaffari A, Meurant R, Ardakani A (2021) COVID-19 point-of-care diagnostics that satisfy global target product profiles. Diagnostics (Basel) 11: 115. https://doi.org/10.3390/diagnostics11010115
    [38] Li Z, Yi Y, Luo X, et al. (2020) Development and clinical application of a rapid IgM-IgG combined antibody test for SARS-CoV-2 infection diagnosis. J Med Virol 92: 1518-1524. https://doi.org/10.1002/jmv.25727
    [39] Andryukov BG (2020) Six decades of lateral flow immunoassay: from determining metabolic markers to diagnosing COVID-19. AIMS Microbiol 6: 280-304. https://doi.org/10.3934/microbiol.2020018
    [40] Ernst E, Wolfe P, Stahura C, et al. (2021) Technical considerations to development of serological tests for SARS-CoV-2. Talanta 224. https://doi.org/10.1016/j.talanta.2020.121883
    [41] Koczula KM, Gallotta A (2016) Lateral flow assays. Essays Biochem 60: 111-120. https://doi.org/10.1042/EBC20150012
    [42] U.S. Food and Drug Administration, Coronavirus (COVID-19) Update: FDA Authorizes First Point-of-Care Antibody Test for COVID-19 (2020). Available from: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-point-care-antibody-test-covid-19
    [43] Jazayeri MH, Amani H, Pourfatollah AA, et al. (2016) Various methods of gold nanoparticles (GNPs) conjugation to antibodies. Sens Bio-Sens Res 9: 17-22. https://doi.org/10.1016/j.sbsr.2016.04.002
    [44] O'Farrell B (2013) Lateral flow immunoassay systems: evolution from the current state of the art to the next generation of highly sensitive, quantitative rapid assays. The Immunoassay Handbook.Elsevier 89-107.
    [45] Albaz AA, Rafeeq MM, Sain ZM, et al. (2021) Nanotechnology-based approaches in the fight against SARS-CoV-2. AIMS Microbiol 7: 368-398. https://doi.org/10.3934/microbiol.2021023
    [46] Hsiao WW, Le TN, Pham DM, et al. (2021) Recent advances in novel lateral flow technologies for detection of COVID-19. Biosensors (Basel) 11: 295. https://doi.org/10.3390/bios11090295
    [47] Karuppaiah G, Vashist A, Nair M, et al. (2023) Emerging trends in point-of-care biosensing strategies for molecular architectures and antibodies of SARS-CoV-2. Biosens Bioelectron X 13: 100324. https://doi.org/10.1016/j.biosx.2023.100324
    [48] Huang C, Wen T, Shi FJ, et al. (2020) Rapid detection of IgM antibodies against the SARS-CoV-2 virus via colloidal gold nanoparticle-based lateral-flow assay. ACS Omega 5: 12550-12556. https://doi.org/10.1021/acsomega.0c01554
    [49] Zhang JJY, Lee KS, Ong CW, et al. (2021) Diagnostic performance of COVID-19 serological assays during early infection: a systematic review and meta-analysis of 11516 samples. Influenza Other Respir Viruses 15: 529-538. https://doi.org/10.1111/irv.12841
    [50] Tessaro L, Aquino A, Panzenhagen P, et al. (2023) A systematic review of the advancement on colorimetric nanobiosensors for SARS-CoV-2 detection. J Pharm Biomed Anal 222: 15087. https://doi.org/10.1016/j.jpba.2022.115087
    [51] Rabiee N, Ahmadi S, Soufi GJ, et al. (2022) Quantum dots against SARS-CoV-2: diagnostic and therapeutic potentials. J Chem Technol Biotechnol 97: 1640-1654. https://doi.org/10.1002/jctb.7036
    [52] Wang C, Yang X, Gu B, et al. (2020) Sensitive and simultaneous detection of SARSCoV-2-specific IgM/IgG using lateral flow immunoassay based on dual-mode quantum dot nanobeads. Anal Chem 92: 15542-15549. https://doi.org/10.1021/acs.analchem.0c03484
    [53] Seo SE, Ryu E, Kim J, et al. (2023) Fluorophore-encapsulated nanobeads for on-site, rapid, and sensitive lateral flow assay. Sens Actuators B Chem 381: 133364. https://doi.org/10.1016/j.snb.2023.133364
    [54] Budd J, Miller BS, Weckman NE, et al. (2023) Lateral flow test engineering and lessons learned from COVID-19. Nat Rev Bioeng 1: 13-31. https://doi.org/10.1038/s44222-022-00007-3
    [55] Chen PY, Ko CH, Wang CJ, et al. (2021) The early detection of immunoglobulins via optical-based lateral flow immunoassay platform in COVID-19 pandemic. PLoS One 16. https://doi.org/10.1371/journal.pone.0254486
    [56] Pieri M, Nicolai E, Nuccetelli M, et al. (2022) Validation of a quantitative lateral flow immunoassay (LFIA)-based point-of-care (POC) rapid test for SARS-CoV-2 neutralizing antibodies. Arch Virol 167: 1285-1291. https://doi.org/10.1007/s00705-022-05422-w
    [57] Castrejón-Jiménez NS, García-Pérez BE, Reyes-Rodríguez NE, et al. (2022) Challenges in the detection of SARS-CoV-2: evolution of the lateral flow immunoassay as a valuable tool for viral diagnosis. Biosensors (Basel) 12: 728. https://doi.org/10.3390/bios12090728
    [58] Burbelo PD, Riedo FX, Morishima C, et al. (2020) Sensitivity in detection of antibodies to nucleocapsid and spike proteins of severe acute respiratory syndrome coronavirus 2 in patients with coronavirus disease 2019. J Infect Dis 222: 206-213. https://doi.org/10.1093/infdis/jiaa273
    [59] Ang GY, Chan KG, Yean CY, et al. (2022) Lateral flow immunoassays for SARS-CoV-2. Diagnostics (Basel) 12: 2854. https://doi.org/10.3390/diagnostics12112854
    [60] Smits VAJ, Hernández-Carralero E, Paz-Cabrera MC, et al. (2021) The Nucleocapsid protein triggers the main humoral immune response in COVID-19 patients. Biochem Biophys Res Commun 543: 45-49. https://doi.org/10.1016/j.bbrc.2021.01.073
    [61] Owen SI, Williams CT, Garrod G, et al. (2022) Twelve lateral flow immunoassays (LFAs) to detect SARS-CoV-2 antibodies. J Infect 84: 355-360. https://doi.org/10.1016/j.jinf.2021.12.007
    [62] Barnes CO, Jette CA, Abernathy ME, et al. (2020) SARS-CoV-2 neutralizing antibody structures inform therapeutic strategies. Nature 588: 682-687. https://doi.org/10.1038/s41586-020-2852-1
    [63] McCallum M, Marco AD, Lempp F, et al. (2021) N-terminal domain antigenic mapping reveals a site of vulnerability for SARS-CoV-2. Cell 184: 2332-2347. https://doi.org/10.1016/j.cell.2021.03.028
    [64] Piccoli L, Park YJ, Tortorici MA, et al. (2020) Mapping neutralizing and immunodominant sites on the SARS-CoV-2 spike receptor-binding domain by structure-guided high-resolution serology. Cell 183: 1024-1042. https://doi.org/10.1016/j.cell.2020.09.037
    [65] Khoury DS, Cromer D, Reynaldi A, et al. (2022) Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection. Nat Med 27: 1205-1211. https://doi.org/10.1038/s41591-021-01377-8
    [66] Post N, Eddy D, Huntley C, et al. (2020) Antibo1dy response to SARS-CoV-2 infection in humans: a systematic review. PLoS One 15: e0244126. https://doi.org/10.1371/journal.pone.0244126
    [67] Kim Y, Bae JY, Kwon K, et al. (2022) Kinetics of neutralizing antibodies against SARS-CoV-2 infection according to sex, age, and disease severity. Sci Rep 12: 13491. https://doi.org/10.1038/s41598-022-17605-1
    [68] Lau EHY, Tsang OTY, Hui DSC, et al. (2021) Neutralizing antibody titres in SARS-CoV-2 infections. Nat Commun 12: 63. https://doi.org/10.1038/s41467-020-20247-4
    [69] Park JH, Cha MJ, Choi H, et al. (2022) Relationship between SARS-CoV-2 antibody titer and the severity of COVID-19. J Microbiol Immunol Infect 55: 1094-1100. https://doi.org/10.1016/j.jmii.2022.04.005
    [70] Tuyji Tok Y, Can Sarinoglu R, Ordekci S, et al. (2023) One-year post-vaccination longitudinal follow-up of quantitative SARS-CoV-2 anti-spike total antibodies in health care professionals and evaluation of correlation with surrogate neutralization test. Vaccines (Basel) 11: 355. https://doi.org/10.3390/vaccines11020355
    [71] Vidal SJ, Collier AY, Yu J, et al. (2021) Correlates of neutralization against SARS-CoV-2 variants of concern by early pandemic sera. J Virol 95: e0040421. https://doi.org/10.1128/JVI.00404-21
    [72] Chen Y, Zhao X, Zhou H, et al. (2023) Broadly neutralizing antibodies to SARS-CoV-2 and other human coronaviruses. Nat Rev Immunol 23: 189-199. https://doi.org/10.1038/s41577-022-00784-3
    [73] Suthar MS, Zimmerman M, Kauffman R, et al. (2020) Rapid generation of neutralizing antibody responses in COVID-19 patients. Cell Rep Med 1. https://doi.org/10.1016/j.xcrm.2020.100040
    [74] Carter LJ, Garner LV, Smoot JW, et al. (2020) Assay techniques and test development for COVID-19 diagnosis. ACS Cent Sci 6: 591-605. https://doi.org/10.1021/acscentsci.0c00501
    [75] Crawford KHD, Eguia R, Dingens AS, et al. (2020) Protocol and reagents for pseudotyping lentiviral particles with SARS-CoV-2 spike protein for neutralization assays. Viruses 12. https://doi.org/10.3390/v12050513
    [76] Hamid S, Tali S, Leblanc JJ, et al. (2021) Tools and techniques for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)/COVID-19 detection. Clin Microbiol Rev 34. https://doi.org/10.1128/CMR.00228-20
    [77] Liu KT, Han YJ, Wu GH, et al. (2022) Overview of neutralization assays and international standard for detecting SARS-CoV-2 neutralizing antibody. Viruses 14: 1560. https://doi.org/10.3390/v14071560
    [78] The Global Fund, List of SARS-CoV-2 Diagnostic test kits and equipments eligible for procurement according to Board Decision on Additional Support for Country Responses to COVID-19 (GF/B42/EDP11) (2023). Available from: https://www.theglobalfund.org/media/9629/covid19_diagnosticproducts_list_en.pdf
    [79] Foundation for Innovative New Diagnostics, COVID-19 test directory. Available from: https://www.finddx.org/tools-and-resources/dxconnect/test-directories/covid-19-test-directory/
    [80] Ochola L, Ogongo P, Mungai S, et al. (2022) Performance Evaluation of Lateral Flow Assays for Coronavirus Disease-19 Serology. Clin Lab Med 42: 31-56. https://doi.org/10.1016/j.cll.2021.10.005
    [81] Filchakova O, Dossym D, Ilyas A, et al. (2022) Review of COVID-19 testing and diagnostic methods. Talanta 244: 123409. https://doi.org/10.1016/j.talanta.2022.123409
    [82] Deshpande PS, Abraham IE, Pitamberwale A, et al. (2022) Review of clinical performance of serology based commercial diagnostic assays for detection of severe acute respiratory syndrome coronavirus 2 antibodies. Viral Immunol 35: 82-111. https://doi.org/10.1089/vim.2020.0313
    [83] Wang Z, Zheng Z, Hu H, et al. (2020) A point-of-care selenium nanoparticle-based test for the combined detection of anti-SARS-CoV-2 IgM and IgG in human serum and blood. Lab Chip 20: 4255-4261. https://doi.org/10.1039/d0lc00828a
    [84] Bastos M, Tavaziva G, Abidi S, et al. (2020) Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis. BMJ . https://doi.org/10.1136/bmj.m2516
    [85] Novello S, Terzolo M, Paola B, et al. (2021) Humoral immune response to SARS-CoV-2 in five different groups of individuals at different environmental and professional risk of infection. Sci Rep 11: 24503. https://doi.org/10.1038/s41598-021-04279-4
    [86] Deeks JJ, Dinnes J, Takwoingi Y, et al. (2020) Antibody tests for identification of current and past infection with SARS-CoV-2. Cochrane Database Syst Rev 6: CD013652. https://doi.org/10.1002/14651858.CD013652
    [87] Pecoraro V, Negro A, Pirotti T, et al. (2022) Estimate false-negative RT-PCR rates for SARS-CoV-2. A systematic review and meta-analysis. Eur J Clin Invest 52: e13706. https://doi.org/10.1111/eci.13706
    [88] Ozturk A, Bozok T, Bozok TS, et al. (2021) Evaluation of rapid antibody test and chest computed tomography results of COVID-19 patients: A retrospective study. J Med Virol 93: 6582-6587. https://doi.org/10.1002/jmv.27209
    [89] Yurtsever I, Karatoprak C, Sumbul B, et al. (2022) Thorax computed tomography findings and anti-SARS-CoV-2 immunoglobulin G levels in polymerase chain reaction-negative probable COVID-19 cases. Rev Assoc Med Bras 68: 1742-1746. https://doi.org/10.1590/1806-9282.20220921
    [90] Chen W, Zhang J, Qin X, et al. (2020) SARS-CoV-2 neutralizing antibody levels are correlated with severity of COVID-19 pneumonia. Biomed Pharmacother 130: 110629. https://doi.org/10.1016/j.biopha.2020.110629
    [91] Jurenka J, Nagyová A, Dababseh M, et al. (2022) Anti-SARS-CoV-2 antibody status at the time of hospital admission and the prognosis of patients with COVID-19: a prospective observational study. Infect Dis Rep 14: 1004-1016. https://doi.org/10.3390/idr14060100
    [92] Jarrom D, Elston L, Washington J, et al. (2022) Effectiveness of tests to detect the presence of SARS-CoV-2 virus, and antibodies to SARS-CoV-2, to inform COVID-19 diagnosis: a rapid systematic review. BMJ Evid Based Med 27: 33-45. https://doi.org/10.1136/bmjebm-2020-111511
    [93] Wang H, Ai J, Loeffelholz MJ, et al. (2020) Meta-analysis of diagnostic performance of serology tests for COVID-19: impact of assay design and post-symptom-onset intervals. Emerg Microbes Infect 9: 2200-2211. https://doi.org/10.1080/22221751.2020.1826362
    [94] Mekonnen D, Mengist HM, Derbie A, et al. (2021) Diagnostic accuracy of serological tests and kinetics of severe acute respiratory syndrome coronavirus 2 antibody: a systematic review and meta-analysis. Rev Med Virol 31: e2181. https://doi.org/10.1002/rmv.2181
    [95] Gracienta TJ, Herardi R, Santosa F, et al. (2021) Diagnostic accuracy of antibody-based rapid diagnostic tests in detecting coronavirus disease 2019: systematic review. Arch Med Sci 18: 949-957. https://doi.org/10.5114/aoms/135910
    [96] Fox T, Geppert J, Dinnes J, et al. (2022) Antibody tests for identification of current and past infection with SARS-CoV-2. Cochrane Database Syst Rev 11: CD013652. https://doi.org/10.1002/14651858.CD013652.pub2
    [97] Kontou PI, Braliou GG, Dimou NL, et al. (2020) Antibody tests in detecting SARS-CoV-2 infection: a meta-analysis. Diagnostics (Basel) 10: 319. https://doi.org/10.3390/diagnostics10050319
    [98] Mohit E, Rostami Z, Vahidi H, et al. (2021) A comparative review of immunoassays for COVID-19 detection. Expert Rev Clin Immunol 17: 573-599. https://doi.org/10.1080/1744666X.2021.1908886
    [99] Fong Y, Huang Y, Benkeser D, et al. (2023) Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial. Nat Commun 14: 331. https://doi.org/10.1038/s41467-022-35768-3
    [100] Tran TT, Vaage EB, Mehta A, et al. (2023) Titers of antibodies against ancestral SARS-CoV-2 correlate with levels of neutralizing antibodies to multiple variants. NPJ Vaccines 7: 174. https://doi.org/10.1038/s41541-023-00600-6
    [101] World Health OrganizationEstablishment of the 2nd WHO International Standard for anti-SARS-CoV-2 immunoglobulin and Reference Panel for antibodies to SARS-CoV-2 variants of concern (2022). Available from: https://www.who.int/publications/m/item/who-bs-2022.2427
    [102] Mulder L, Carrères B, Muggli F, et al. (2022) A comparative study of nine SARS-CoV-2 IgG lateral flow assays using both post-infection and post-vaccination samples. J Clin Med 11: 2100. https://doi.org/10.3390/jcm11082100
    [103] Peghin M, Bontempo G, De Martino M, et al. (2022) Evaluation of qualitative and semi-quantitative cut offs for rapid diagnostic lateral flow test in relation to serology for the detection of SARS-CoV-2 antibodies: findings of a prospective study. BMC Infect Dis 22: 810. https://doi.org/10.1186/s12879-022-07786-5
    [104] Findlater L, Trickey A, Jones HE, et al. (2022) Association of results of four lateral flow antibody tests with subsequent SARS-CoV-2 infection. Microbiol Spectr 10: e0246822. https://doi.org/10.1128/spectrum.02468-22
    [105] Choi HW, Jeon CH, Won EJ, et al. (2022) Performance of severe acute respiratory syndrome coronavirus 2 serological diagnostic tests and antibody kinetics in coronavirus disease 2019 patients. Front Microbiol 13: 881038. https://doi.org/10.3389/fmicb.2022.881038
    [106] Pan X, Kaminga AC, Chen Y, et al. (2022) Auxiliary screening COVID-19 by serology. Front Public Health 10: 819841. https://doi.org/10.3389/fpubh.2022.819841
    [107] Zhu L, Xu X, Zhu B, et al. (2021) Kinetics of SARS-CoV-2 specific and neutralizing antibodies over seven months after symptom onset in COVID-19 patients. Microbiol Spectr 9: e0059021. https://doi.org/10.1128/Spectrum.00590-21
    [108] Chansaenroj J, Yorsaeng R, Puenpa J, et al. (2022) Long-term persistence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein-specific and neutralizing antibodies in recovered COVID-19 patients. PLoS One 17: e0267102. https://doi.org/10.1371/journal.pone.0267102
    [109] Chansaenroj J, Yorsaeng R, Posuwan N, et al. (2021) Detection of SARS-CoV-2-specific antibodies via rapid diagnostic immunoassays in COVID-19 patients. Virol J 18: 52. https://doi.org/10.1186/s12985-021-01530-2
    [110] Spicuzza L, Sambataro G, Bonsignore M, et al. (2022) Point of care antibody detection assays for past SARS-CoV-2 infection are accurate over the time. Infect Dis (Lond) 54: 464-466. https://doi.org/10.1080/23744235.2022.2036810
    [111] Robertson LJ, Moore JS, Blighe K, et al. (2021) Evaluation of the IgG antibody response to SARS CoV-2 infection and performance of a lateral flow immunoassay: cross-sectional and longitudinal analysis over 11 months. BMJ Open 11: e048142. https://doi.org/10.1136/bmjopen-2020-048142
    [112] Ong DSY, Fragkou PC, Schweitzer VA, et al. (2021) How to interpret and use COVID-19 serology and immunology tests. Clin Microbiol Infect 27: 981-986. https://doi.org/10.1016/j.cmi.2021.05.001
    [113] Tong H, Cao C, You M, et al. (2022) Artificial intelligence-assisted colorimetric lateral flow immunoassay for sensitive and quantitative detection of COVID-19 neutralizing antibody. Biosens Bioelectron 213: 114449. https://doi.org/10.1016/j.bios.2022.114449
    [114] Pallett SJC, Rayment M, Heskin J, et al. (2022) Early identification of high-risk individuals for monoclonal antibody therapy and prophylaxis is feasible by SARS-CoV-2 anti-spike antibody specific lateral flow assay. Diagn Microbiol Infect Dis 104: 115788. https://doi.org/10.1016/j.diagmicrobio.2022.115788
    [115] Brownstein NC, Chen YA (2021) Predictive values, uncertainty, and interpretation of serology tests for the novel coronavirus. Sci Rep 11: 5491. https://doi.org/10.1038/s41598-021-84173-1
    [116] Van den Hoogen LL, Smits G, van Hagen CCE, et al. (2022) Seropositivity to nucleoprotein to detect mild and asymptomatic SARS-CoV-2 infections: a complementary tool to detect breakthrough infections after COVID-19 vaccination?. Vaccine 40: 2251-2257. https://doi.org/10.1016/j.vaccine.2022.03.009
    [117] Liu L, Wang P, Nair MS, et al. (2020) Potent neutralizing antibodies against multiple epitopes on SARS-CoV-2 spike. Nature 584: 450-456. https://doi.org/10.1038/s41586-020-2571-7
    [118] Biby A, Wang X, Liu X, et al. (2022) Rapid testing for coronavirus disease 2019 (COVID-19). MRS Commun 12: 12-23. https://doi.org/10.1557/s43579-021-00146-5
    [119] Bradley T, Grundberg E, Selvarangan R, et al. (2021) Antibody responses boosted in seropositive healthcare workers after single dose of SARS-CoV-2 mRNA vaccine. MedRxiv . https://doi.org/10.1101/2021.02.03.21251078
    [120] Baldanti F, Ganguly NK, Wang G, et al. (2022) Choice of SARS-CoV-2 diagnostic test: challenges and key considerations for the future. Crit Rev Clin Lab Sci 59: 445-459. https://doi.org/10.1080/10408363.2022.2045250
    [121] Kitchin N Pfizer/BioNTech COVID-19 mRNA vaccine (2020). Available from: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-08/Pfizer-COVID-19-vaccine-ACIP-presentation-508.pdf
    [122] Sami S, Tenforde MW, Talbot HK, et al. (2021) Adults hospitalized with coronavirus disease 2019 (COVID-19)-United States, March-June and October-December 2020: implications for the potential effects of COVID-19 Tier-1 vaccination on future hospitalizations and outcomes. Clin Infect Dis 73: S32-S37. https://doi.org/10.1093/cid/ciab319
    [123] Cann A, Clarke C, Brown J, et al. (2022) Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody lateral flow assay for antibody prevalence studies following vaccination: a diagnostic accuracy study. Wellcome Open Res 6: 358. https://doi.org/10.12688/wellcomeopenres.17231.2
    [124] Fulford TS, Van H, Gherardin NA, et al. (2021) A point-of-care lateral flow assay for neutralising antibodies against SARS-CoV-2. EBioMedicine 74: 103729. https://doi.org/10.1016/j.ebiom.2021.103729
    [125] Shurrab FM, Younes N, Al-Sadeq DW, et al. (2022) Performance evaluation of novel fluorescent-based lateral flow immunoassay (LFIA) for rapid detection and quantification of total anti-SARS-CoV-2 S-RBD binding antibodies in infected individuals. Int J Infect Dis 118: 132-137. https://doi.org/10.1016/j.ijid.2022.02.052
    [126] Moeller ME, Engsig FN, Bade M, et al. (2022) Rapid quantitative point-of-care diagnostic test for post COVID-19 vaccination antibody monitoring. Microbiol Spectr 10: e0039622. https://doi.org/10.1128/spectrum.00396-22
    [127] Greenland-Bews C, Byrne RL, Owen SI, et al. (2023) Evaluation of eight lateral flow tests for the detection of anti-SARS-CoV-2 antibodies in a vaccinated population. BMC Infect Dis 23: 110. https://doi.org/10.1186/s12879-023-08033-1
    [128] Lee W, Kurien P (2023) Evaluation of a point of care lateral flow assay for antibody detection following SARS CoV-2 mRNA vaccine series. J Immunol Methods 513: 113410. https://doi.org/10.1016/j.jim.2022.113410
    [129] Nickel O, Rockstroh A, Borte S, et al. (2022) Evaluation of simple lateral flow immunoassays for detection of SARS-CoV-2 neutralizing antibodies. Vaccines (Basel) 10: 347. https://doi.org/10.3390/vaccines10030347
    [130] Wang Q, Feng L, Zhang H, et al. (2022) Longitudinal waning of mRNA vaccine-induced neutralizing antibodies against SARS-CoV-2 detected by an LFIA rapid test. Antib Ther 5: 55-62. https://doi.org/10.1093/abt/tbac004
    [131] Sauré D, O'Ryan M, Torres JP, et al. (2023) COVID-19 lateral flow IgG seropositivity and serum neutralising antibody responses after primary and booster vaccinations in Chile: a cross-sectional study. Lancet Microbe 4: e149-e158. https://doi.org/10.1016/S2666-5247(22)00290-7
    [132] Akkız H (2022) The biological functions and clinical significance of SARS-CoV-2 variants of corcern. Front Med (Lausanne) 9: 849217. https://doi.org/10.3389/fmed.2022.849217
    [133] Khan K, Karim F, Ganga Y, et al. (2022) Omicron BA.4/BA.5 escape neutralizing immunity elicited by BA.1 infection. Nat Commun 13: 4686. https://doi.org/10.1038/s41467-022-32396-9
    [134] Cao Y, Wang J, Jian F, et al. (2022) Omicron escapes the majority of existing SARS-CoV-2 neutralizing antibodies. Nature 602: 657-663. https://doi.org/10.1038/s41467-022-32396-9
    [135] Groenheit R, Galanis I, Sondén K, et al. (2023) Rapid emergence of omicron sublineages expressing spike protein R346T. Lancet Reg Health Eur 24: 100564. https://doi.org/10.1016/j.lanepe.2022.100564
    [136] Ao D, He X, Hong W, et al. (2023) The rapid rise of SARS-CoV-2 Omicron subvariants with immune evasion properties: XBB.1.5 and BQ.1.1 subvariants. MedComm 4: e239. https://doi.org/10.1002/mco2.239
    [137] Thomas SJ, Moreira Jr ED, Kitchin N, et al. (2021) Safety and efficacy of the BNT162b2 mRNA Covid-19 vaccine through 6 months. N Engl J Med 385: 1761-1773. https://doi.org/10.1038/s41467-022-32396-9
    [138] Gao F, Zheng M, Fan J, et al. (2023) A trimeric spike-based COVID-19 vaccine candidate induces broad neutralization against SARS-CoV-2 variants. Hum Vaccin Immunother 19: 2186110. https://doi.org/10.1080/21645515.2023.2186110
    [139] Singh J, Samal J, Kumar V, et al. (2021) Structure-function analyses of new SARS-CoV-2 variants B.1.1.7, B.1.351 and B.1.1.28.1: clinical, diagnostic, therapeutic and public health implications. Viruses 13: 439. https://doi.org/10.3390/v13030439
    [140] Lu L, Chen LL, Zhang RR, et al. (2022) Boosting of serum neutralizing activity against the Omicron variant among recovered COVID-19 patients by BNT162b2 and CoronaVac vaccines. EBioMedicine 79: 103986. https://doi.org/10.1016/j.ebiom.2022.103986
    [141] Rössler A, Knabl L, Raschbichler LM, et al. (2023) Reduced sensitivity of antibody tests after omicron infection. Lancet Microbe 4: e10-e11. https://doi.org/10.1016/S2666-5247(22)00222-1
    [142] Springer DN, Perkmann T, Jani CM, et al. (2022) Reduced sensitivity of commercial spike-specific antibody assays after primary infection with the SARS-CoV-2 Omicron variant. Microbiol Spectr 10: e0212922. https://doi.org/10.1128/spectrum.02129-22
    [143] Heggestad JT, Britton RJ, Kinnamon DS, et al. (2023) COVID-19 diagnosis and SARS-CoV-2 strain identification by a rapid, multiplexed, point-of-care antibody microarray. Anal Chem 95: 5610-5617. https://doi.org/10.1021/acs.analchem.2c05180
    [144] Falzone L, Gattuso G, Tsatsakis A, et al. (2021) Current and innovative methods for the diagnosis of COVID-19 infection. Int J Mol Med 47. https://doi.org/10.3892/ijmm.2021.4933
  • Reader Comments
  • © 2023 the Author(s), licensee AIMS Press. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0)
通讯作者: 陈斌, bchen63@163.com
  • 1. 

    沈阳化工大学材料科学与工程学院 沈阳 110142

  1. 本站搜索
  2. 百度学术搜索
  3. 万方数据库搜索
  4. CNKI搜索

Metrics

Article views(1859) PDF downloads(92) Cited by(0)

Article outline

Figures and Tables

Figures(2)  /  Tables(3)

/

DownLoad:  Full-Size Img  PowerPoint
Return
Return

Catalog