Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2021 Nov:10.2217/fvl-2021-0211.
doi: 10.2217/fvl-2021-0211. Epub 2021 Dec 15.

A systematic review and meta-analysis of the sensitivity of antibody tests for the laboratory confirmation of COVID-19

Nigel A Makoah  1 , Thomas Tipih  1 , Matefo M Litabe  1 , Mareza Brink  2 , Joseph B Sempa  3   4 , Dominique Goedhals  1   5 , Felicity J Burt  1   5
Affiliations
Review

A systematic review and meta-analysis of the sensitivity of antibody tests for the laboratory confirmation of COVID-19

Nigel A Makoah et al. Future Virol. 2021 Nov.

Abstract

Aim: 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. Materials & methods: 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. Results: We found that the highest pooled sensitivities were obtained with ELISA IgM-IgG and chemiluminescence immunoassay IgM tests. Conclusion: 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.

Keywords: COVID-19; RT-PCR; laboratory diagnosis; serology.

PubMed Disclaimer

Conflict of interest statement

Financial & competing interests disclosure We would like to thank NRF SARChI Vector borne and zoonotic pathogens research (Grant number 98346) and the NRF Thuthuka (Grant number 129875) for the support on our research on SARS-CoV-2. D Goedhals is affiliated with the National Health Laboratory Service, PathCare Vermaak (Pretoria, South Africa) and University of the Free State (Bloemfontein, South Africa). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.

Figures

Figure 1.
Figure 1.. Studies considered and included.
Figure 2.
Figure 2.. Forest plot of sensitivity for lateral flow immunochromatographic assay serological diagnosis of COVID-19.
(A) LFIA IgG tests. (B) LFIA IgM tests. (C) LFIA IgM-IgG tests. LFIA: Lateral flow immunochromatographic assay.
Figure 3.
Figure 3.. Forest plot of sensitivity for chemiluminescence immunoassay serological diagnosis of COVID-19.
(A) CLIA IgG tests. (B) CLIA IgM tests. (C) CLIA IgM-IgG tests. (D) CLIA Total antibody tests. CLIA: Chemiluminescence immunoassay.
Figure 4.
Figure 4.. Forest plot of sensitivity for ELISA diagnosis of COVID-19.
(A) ELISA IgG tests. (B) ELISA IgM tests. (C) ELISA IgM-IgG tests.
Figure 5.
Figure 5.. Forest plot of sensitivity and specificity for lateral flow immunochromatographic assay serological diagnosis of COVID-19.
(A) LFIA IgG tests. (B) LFIA IgM tests. (C) LFIA IgM-IgG tests. LFIA: Lateral flow immunochromatographic assay.
Figure 6.
Figure 6.. Forest plot of sensitivity and specificity for chemiluminescence immunoassay serological diagnosis of COVID-19.
(A) CLIA IgG tests. (B) CLIA IgM tests. (C) CLIA IgM-IgG tests. (D) CLIA Total antibody tests. CLIA: Chemiluminescence immunoassay.
Figure 7.
Figure 7.. Forest plot of sensitivity and specificity for ELISA diagnosis of COVID-19.
(A) ELISA IgG tests. (B) ELISA IgM tests. (C) ELISA IgM-IgG tests.
See this image and copyright information in PMC

References

    1. Ren LL, Wang YM, Wu ZQ et al. Identification of a novel coronavirus causing severe pneumonia in human: a descriptive study. Chin. Med. J (Engl). 133(9), 1015–1024 (2020). - PMC - PubMed
    1. Kim D, Lee JY, Yang JS, Kim JW, Kim VN, Chang H. The architecture of SARS-CoV-2 transcriptome. Cell 181(4), 914–921 e10 (2020). - PMC - PubMed
    1. Yadav R, Chaudhary JK, Jain N et al. Role of structural and non-structural proteins and therapeutic targets of SARS-CoV-2 for COVID-19. Cells 10(4), 821 (2021). - PMC - PubMed
    1. World Health Organization. Laboratory testing for coronavirus disease 2019 (COVID-19) in suspected human cases: interim guidance (2020). https://apps.who.int/iris/handle/10665/331329
    1. Alandijany TA, El-Kafrawy SA, Tolah AM et al. Development and optimization of in-house ELISA for detection of human IgG antibody to SARS-CoV-2 full length spike protein. Pathogens 9(10), 803 (2020). - PMC - PubMed

LinkOut - more resources