A Systematic Review and Meta-analysis of the Sensitivity of Antibody Tests for the Laboratory Confirmation of COVID-19

Overview

Journal Future Virol

Specialty Microbiology

Date 2021 Dec 24

PMID 34950219

Citations 13

Authors

Nigel A Makoah

Thomas Tipih

Matefo M Litabe

Mareza Brink

Joseph B Sempa

Dominique Goedhals

Felicity J Burt

Affiliations

Soon will be listed here.

Abstract

The aim of this study was to investigate the utility of serological tests for the diagnosis of COVID-19 during the first week of symptom onset in patients confirmed with the real-time RT-PCR. A systematic review and meta-analysis of 58 publications were performed using data obtained from Academic Search Ultimate, Africa-wide, Scopus, Web of Science and MEDLINE. We found that the highest pooled sensitivities were obtained with ELISA IgM-IgG and chemiluminescence immunoassay IgM tests. Serological tests have low sensitivity within the first week of symptom onset and cannot replace nucleic acid amplification tests. However, serological assays can be used to support nucleic acid amplification tests.

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References

Du J, Chu E, Zhang D, Lu C, Zhang A, Sha M . A high-throughput Anti-SARS-CoV-2 IgG testing platform for COVID-19. J Virol Methods. 2020; 287:114009. PMC: 7605757. DOI: 10.1016/j.jviromet.2020.114009. View

Cavalera S, Colitti B, Rosati S, Ferrara G, Bertolotti L, Nogarol C . A multi-target lateral flow immunoassay enabling the specific and sensitive detection of total antibodies to SARS COV-2. Talanta. 2020; 223(Pt 1):121737. PMC: 7534878. DOI: 10.1016/j.talanta.2020.121737. View

Lou B, Li T, Zheng S, Su Y, Li Z, Liu W . Serology characteristics of SARS-CoV-2 infection after exposure and post-symptom onset. Eur Respir J. 2020; 56(2). PMC: 7401320. DOI: 10.1183/13993003.00763-2020. View

Shamsollahi H, Amini M, Alizadeh S, Nedjat S, Akbari-Sari A, Rezaei M . Validity of a Serological Diagnostic Kit for SARS-CoV-2 Available in Iran. Arch Iran Med. 2020; 23(9):629-632. DOI: 10.34172/aim.2020.75. View

Grzelak L, Temmam S, Planchais C, Demeret C, Tondeur L, Huon C . A comparison of four serological assays for detecting anti-SARS-CoV-2 antibodies in human serum samples from different populations. Sci Transl Med. 2020; 12(559). PMC: 7665313. DOI: 10.1126/scitranslmed.abc3103. View

Rosado J, Pelleau S, Cockram C, Merkling S, Nekkab N, Demeret C . Multiplex assays for the identification of serological signatures of SARS-CoV-2 infection: an antibody-based diagnostic and machine learning study. Lancet Microbe. 2021; 2(2):e60-e69. PMC: 7837364. DOI: 10.1016/S2666-5247(20)30197-X. View

Kubo S, Ohtake N, Miyakawa K, Jeremiah S, Yamaoka Y, Murohashi K . Development of an Automated Chemiluminescence Assay System for Quantitative Measurement of Multiple Anti-SARS-CoV-2 Antibodies. Front Microbiol. 2021; 11:628281. PMC: 7843449. DOI: 10.3389/fmicb.2020.628281. View

Qu J, Wu C, Li X, Zhang G, Jiang Z, Li X . Profile of Immunoglobulin G and IgM Antibodies Against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Clin Infect Dis. 2020; 71(16):2255-2258. PMC: 7197626. DOI: 10.1093/cid/ciaa489. View

Kang K, Huang L, Ouyang C, Du J, Yang B, Chi Y . Development, performance evaluation, and clinical application of a Rapid SARS-CoV-2 IgM and IgG Test Kit based on automated fluorescence immunoassay. J Med Virol. 2020; 93(5):2838-2847. PMC: 7753814. DOI: 10.1002/jmv.26696. View

10.

Tan S, Saw S, Chew K, Wang C, Pajarillaga A, Khoo C . Comparative Clinical Evaluation of the Roche Elecsys and Abbott Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Serology Assays for Coronavirus Disease 2019 (COVID-19). Arch Pathol Lab Med. 2020; 145(1):32-38. DOI: 10.5858/arpa.2020-0499-SA. View

11.

McAulay K, Bryan A, Greninger A, Grill F, Lake D, Kaleta E . Retrospective clinical evaluation of 4 lateral flow assays for the detection of SARS-CoV-2 IgG. Diagn Microbiol Infect Dis. 2020; 98(3):115161. PMC: 7395943. DOI: 10.1016/j.diagmicrobio.2020.115161. View

12.

Van Elslande J, Decru B, Jonckheere S, Van Wijngaerden E, Houben E, Vandecandelaere P . Antibody response against SARS-CoV-2 spike protein and nucleoprotein evaluated by four automated immunoassays and three ELISAs. Clin Microbiol Infect. 2020; 26(11):1557.e1-1557.e7. PMC: 7834107. DOI: 10.1016/j.cmi.2020.07.038. View

13.

Theel E, Harring J, Hilgart H, Granger D . Performance Characteristics of Four High-Throughput Immunoassays for Detection of IgG Antibodies against SARS-CoV-2. J Clin Microbiol. 2020; 58(8). PMC: 7383546. DOI: 10.1128/JCM.01243-20. View

14.

Patel E, Bloch E, Clarke W, Hsieh Y, Boon D, Eby Y . Comparative Performance of Five Commercially Available Serologic Assays To Detect Antibodies to SARS-CoV-2 and Identify Individuals with High Neutralizing Titers. J Clin Microbiol. 2020; 59(2). PMC: 8111143. DOI: 10.1128/JCM.02257-20. View

15.

Wang Y, Zhang L, Sang L, Ye F, Ruan S, Zhong B . Kinetics of viral load and antibody response in relation to COVID-19 severity. J Clin Invest. 2020; 130(10):5235-5244. PMC: 7524490. DOI: 10.1172/JCI138759. View

16.

Egger M, Bundschuh C, Wiesinger K, Gabriel C, Clodi M, Mueller T . Comparison of the Elecsys® Anti-SARS-CoV-2 immunoassay with the EDI™ enzyme linked immunosorbent assays for the detection of SARS-CoV-2 antibodies in human plasma. Clin Chim Acta. 2020; 509:18-21. PMC: 7261064. DOI: 10.1016/j.cca.2020.05.049. View

17.

Maine G, Lao K, Mallika Krishnan S, Afolayan-Oloye O, Fatemi S, Kumar S . Longitudinal characterization of the IgM and IgG humoral response in symptomatic COVID-19 patients using the Abbott Architect. J Clin Virol. 2020; 133:104663. PMC: 7590643. DOI: 10.1016/j.jcv.2020.104663. View

18.

Deeks J, Dinnes J, Takwoingi Y, Davenport C, Spijker R, Taylor-Phillips S . Antibody tests for identification of current and past infection with SARS-CoV-2. Cochrane Database Syst Rev. 2020; 6:CD013652. PMC: 7387103. DOI: 10.1002/14651858.CD013652. View

19.

Coste A, Jaton K, Papadimitriou-Olivgeris M, Greub G, Croxatto A . Comparison of SARS-CoV-2 serological tests with different antigen targets. J Clin Virol. 2020; 134:104690. PMC: 7670982. DOI: 10.1016/j.jcv.2020.104690. View

20.

Fong C, Cai J, Dissanayake T, Chen L, Choi C, Wong L . Improved Detection of Antibodies against SARS-CoV-2 by Microsphere-Based Antibody Assay. Int J Mol Sci. 2020; 21(18). PMC: 7555114. DOI: 10.3390/ijms21186595. View