Antibody Tests in Detecting SARS-CoV-2 Infection: A Meta-Analysis

Abstract

The emergence of Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 made imperative the need for diagnostic tests that can identify the infection. Although Nucleic Acid Test (NAT) is considered to be the gold standard, serological tests based on antibodies could be very helpful. However, individual studies are usually inconclusive, thus, a comparison of different tests is needed. We performed a systematic review and meta-analysis in PubMed, medRxiv and bioRxiv. We used the bivariate method for meta-analysis of diagnostic tests pooling sensitivities and specificities. We evaluated IgM and IgG tests based on Enzyme-linked immunosorbent assay (ELISA), Chemiluminescence Enzyme Immunoassays (CLIA), Fluorescence Immunoassays (FIA), and the Lateral Flow Immunoassays (LFIA). We identified 38 studies containing data from 7848 individuals. Tests using the S antigen are more sensitive than N antigen-based tests. IgG tests perform better compared to IgM ones and show better sensitivity when the samples were taken longer after the onset of symptoms. Moreover, a combined IgG/IgM test seems to be a better choice in terms of sensitivity than measuring either antibody alone. All methods yield high specificity with some of them (ELISA and LFIA) reaching levels around 99%. ELISA- and CLIA-based methods perform better in terms of sensitivity (90%–94%) followed by LFIA and FIA with sensitivities ranging from 80% to 89%. ELISA tests could be a safer choice at this stage of the pandemic. LFIA tests are more attractive for large seroprevalence studies but show lower sensitivity, and this should be taken into account when designing and performing seroprevalence studies.

COVID‐19 Clinical Diagnostics and Testing Technology

“…A combined IgG/IgM test displayed better sensitivity than measuring either antibody type alone with ELISA tests being more sensitive than lateral flow immunoassays. 63 A recent study found high sensitivity and specificity of the RBD for antibody detection and its strong association with SARS-CoV-2 neutralizing antibodies. 59 Studies are ongoing to determine the clinical performance characteristics of various antibody tests across different platforms.…”

Clinical and laboratory evaluation of SARS-CoV-2 lateral flow assays for use in a national COVID-19 seroprevalence survey

“…immunoassays (LFIAs) offer the potential for relatively cheap tests that are easily distributed and can be either self-administered or performed by trained healthcare workers. However, despite manufacturers' claims of high sensitivity and specificity, reported performance of these assays has been variable [3][4][5][6][7][8][9] and their use is limited to date. In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) requires that clinical sensitivity and specificity must be determined for each claimed specimen type, and that sample equivalence must be shown.…”

SARS-CoV-2 seroprevalence in oncology healthcare professionals and patients with cancer at a tertiary care centre during the COVID-19 pandemic

“…More importantly, a serological test could capture previous asymptomatic infections and help to assess the immune status of a subject and finally estimate herd immunity. 12 Worldwide, several countries are going to ease the restriction measurements after the initial COVID-19 wave faded away. However, the SARS-CoV-2 seroprevalence is still low in the population, and herd immunity has not been developed.…”