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

Importance

Serology tests are diagnostic and complementary to molecular tests during the COVID-19 pandemic.

Objective

To evaluate the diagnostic accuracy of FDA authorized serology tests for the detection of SARS-CoV-2 infection.

Data sources

A 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 Selection

Manufacturer reported serology tests published in the FDA website were selected. Two reviewers independently assessed the eligibility of the selected reports.

Data extraction and synthesis

The 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 measures

The 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.

Results

Seven 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 relevance

FDA 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

Questions

What is the pooled diagnostic accuracy of FDA authorized serology tests to detect SARS-CoV-2 antibodies?

Findings

In 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.

Meaning

FDA 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.