Meta-analysis of diagnostic performance of serological tests for SARS-CoV-2 antibodies up to 25 April 2020 and public health implications

June 11, 2020

Caini S, Bellerba F, Corso F, et al.

medRxiv

This meta-analysis included nine studies examining the performance of antibody tests, including six commercially available kits and three in-house tests (ELISA, CMIA, or CLIA assays). Among the commercially available kits, the Beijing Wantai kit (Beijing Wantai Biological, Beijing, China), was used in three of the publications, demonstrating a sensitivity ranging from 0.93 to 0.98 and a specificity ranging from 0.99-1.00 for total Ab detected. For IgM detection, the kit demonstrated a sensitivity ranging from 0.83 to 0.93 and specificity ranging from 0.99 to 1.00, and for IgG detection the kit demonstrated sensitivity ranging from 0.65 to 0.89 and specificity ranging from 0.99 to 1.00. The Xiamen InnoDx Biotech kit (Xiamen InnoDx Biotech Co., Xiamen, China), was used in one of the included studies, and demonstrated a sensitivity of 0.86 and specificity of 0.99 for IgM Ab detection, and a sensitivity of 0.96 and specificity of 0.99 for total Ab detection. The pooled summary estimates of sensitivity across all serological tests included in the systematic review were 0.82 for IgM, 0.85 for IgG, and 0.85 for total Ab. Pooled summary estimates for specificities were 0.98 for IgM, 0.99 for IgG, and 0.99 for detection of total Ab.

Caini S, Bellerba F, Corso F, et al. Meta-analysis of diagnostic performance of serological tests for SARSCoV-2 antibodies and public health implications. Medrxiv 2020; : 1–5.

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