Diagnostic Accuracy of FDA Authorized Serology Tests to Detect SARS-CoV-2 Antibodies: A Systematic Review and Meta-analysis

Pandey, Rajesh; Gourishankar, Anand

ImportanceSerology tests are diagnostic and complementary to molecular tests during the COVID-19 pandemic. ObjectiveTo evaluate the diagnostic accuracy of FDA authorized serology tests for the detection of SARS-CoV-2 infection. Data sourcesA search of MEDLINE, SCOPUS, CINAHL Plus, and EMBASE up to April 4, 2020, was performed to identify studies using the "COVID 19 testing" and "meta-analysis." FDA website was accessed for the list of tests for emergency use authorization (EUA). Study SelectionManufacturer reported serology tests published in the FDA website were selected. Two reviewers independently assessed the eligibility of the selected reports. Data extraction and synthesisThe meta-analysis was performed in accordance with the PRISMA guidelines. A bivariate analysis using the "random-effects model" was applied for pooled summary estimates of sensitivity, specificity, and the summary receiver operating characteristic curves. Main outcomes and measuresThe primary outcome was the diagnostic accuracy of the serology test for detecting SARS-CoV-2 infection. Subgroup analysis of the diagnostic accuracy with lag time between symptom onset and testing were studied. ResultsSeven manufacturer listed reports were included. The pooled sensitivity was 87% (95% CI, 78% - 93%), the pooled specificity was 100% (95% CI, 97% - 100%), and the area under the hierarchical summary receiver operating characteristic curve was 0.97. At [≤] 7 days, sensitivity was 44% (95% CI, 21% - 70%), and for 8-14 days, sensitivity was 84% (95% CI, 67 % - 94%).For blood draws [≥] 15 days after the onset of symptoms, sensitivity was 96% (95% CI, 93% - 98%). Heterogeneity was substantial, and the risk of bias was low in this analysis. Conclusions and relevanceFDA authorized serology tests demonstrate high diagnostic accuracy for SARS-CoV-2 infection (certainty of evidence: moderate). There is a wide variation in the test accuracy based on the duration between the onset of symptoms and the tests (certainty of evidence: low). Key- points QuestionsWhat is the pooled diagnostic accuracy of FDA authorized serology tests to detect SARS-CoV-2 antibodies? FindingsIn this systematic review and meta-analysis of seven reports from FDA authorized serology tests to detect antibodies against SARS-CoV2 antibodies (3336 patients/ samples) pooled sensitivity was 87%, and pooled specificity was almost 100%. There was a wide variation in test performance based on the duration between the onset of symptoms and the tests. MeaningFDA authorized tests are highly accurate to detect antibodies against SARS-CoV-2 antibodies if tests are performed under a similar condition, as presented in the original report. There is a wide variation in the test performance based on the time interval between the onset of symptoms to the tests.