An Indirect Comparison of Diagnostic Accuracy for Seven Different SARS-CoV-2 Serological Assays: A Meta-Analysis and Adjusted Indirect Comparison of Diagnostic Test Accuracy.

OBJECTIVES

This study compared the diagnostic accuracy of seven different commercial serological assays for COVID-19, using RT-PCR as the gold standard, through meta-analysis and indirect comparison.

METHODS

Fifty-seven studies, published from November 2019 to June 2024, were included. The diagnostic performance of IgA, IgG, and total antibody assays for SARS-CoV-2 was assessed. The netmeta, rjags, and gemtc packages in R software were used for adjusted indirect comparison to calculate the relative diagnostic odds ratio (RDOR).

RESULTS

The pooled diagnostic odds ratio (DOR) for Abbott SARS-CoV-2 IgG was 542.81, for Elecsys Anti-SARS-CoV-2 N was 1022.34, for Elecsys Anti-SARS-CoV-2 total was 1701.56, for Euroimmun Anti-SARS-CoV-2 IgA was 45.91, for Euroimmun Anti-SARS-CoV-2 S1-IgG was 190.45, for Euroimmun Anti-SARS-CoV-2 N-IgG was 82.63, and for LIAISON SARS-CoV-2 S1/S2 IgG was 178.73. The pooled DOR for IgG, IgA, and total antibody assays was 241.43, 45.91, and 1124.48. The pooled DOR for the antinucleocapsid antigen (anti-N) was 604.29; for the antidomain of viral spike protein (anti-S1) and the antirecombinant S1 and S2 (anti-S1/S2) antigens, the pooled DORs were 119.88 and 178.73. ECLIA and CMIA methods had superior diagnostic performance compared with CLIA and ELISA, with no significant difference between ECLIA and CMIA. Total antibody assays showed the highest accuracy, followed by IgG, with IgA performing least effectively.

CONCLUSIONS

Elecsys Anti-SARS-CoV-2 total and N assays had the best overall diagnostic test accuracy. The diagnostic efficacy of the anti-N total, IgG antibodies was statistically significantly higher than that of anti-S IgG and IgA antibodies for COVID-19.