Abstract
Background and aims Serologic assays for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies are being developed and approved rapidly with limited external validation. Accurate diagnostics are an essential component to pandemic management and public health.
Materials and methods Residual serum samples (N=113) from patients who were evaluated for SARS-CoV-2 infection status by polymerase chain reaction (PCR) were retrospectively tested in parallel across three automated SARS-CoV-2 serologic assays: Liaison SARS-CoV-2 S1/S2 IgG, Elecsys anti-SARS-CoV-2 total antibody, and Access SARS-CoV-2 IgG.
Results Testing of 51 PCR-positive and 62 PCR-negative patients demonstrated qualitative inter-test agreement of 96% overall, 100% in PCR-negative patients, 88% in early positive samples (0-13 days post positive PCR), and 100% in convalescent samples (14+ days post positive PCR).
Calculated kappa values for paired inter-test agreement ranged 0.93-0.96. Compared to PCR, overall percent positive agreement ranged from 82-86% (100% for convalescent samples) and percent negative agreement was 100% for each assay.
Conclusion This study demonstrates high diagnostic accuracy and inter-test agreement for three automated SARS-CoV-2 serologic assays. External validation of serologic assays is critical to ensure diagnostic accuracy and appropriate utilization of critical resources.
Competing Interest Statement
The authors have declared no competing interest.
Funding Statement
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
University of Kansas Medical Center Human Research Protection Program Institutional Review Board Study #00145715
All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.
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Footnotes
Funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Declaration of Interest: None.
Data Availability
No supplementary material or external datasets are available for this article.