Abstract
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).
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.
Competing Interest Statement
The authors have declared no competing interest.
Funding Statement
None
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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Footnotes
Funding Source: No external funding for this manuscript.
Financial Disclosure: All authors have indicated they have no financial relationships relevant to this article to disclose.
Potential conflict of Interest: The authors have no conflicts of interest relevant to this article to disclose
Clinical Trial Registration: Not applicable
Abbreviations: Coronavirus disease (COVID-19); reverse transcription-polymerase chain reaction (RT-PCR), World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), Immunoglobulin G (IgG), Immunoglobulin M (IgM), severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Area under curve (AUC), Summary receiver operating characteristic (SROC)
Data Availability
This project is based on publicly available data from the FDA website.