Abstract
This study compared the performance of four serology assays for Coronavirus Disease 2019 (COVID-19) and investigated whether COVID-19 disease history correlates with assay performance. Samples were tested at Northshore using the Elecsys Anti-SARS-CoV-2 (Roche Diagnostics), Access SARS-CoV-2 IgG anti-RBD (Beckman Coulter), and LIAISON SARS-CoV-2 S1/S2 IgG (DiaSorin) as well as at Genalyte using Maverick Multi-Antigen Serology Panel. The study included one hundred clinical samples collected before December 2019 and ninety-seven samples collected from convalescent plasma donors originally diagnosed with COVID-19 by PCR. COVID-19 disease history was self-reported by the plasma donors. There was no difference in specificity between the assays tested. Clinical sensitivity of these four tests was 98% (Genalyte), 96% (Roche), 92% (DiaSorin), and 87% (Beckman). The only statistically significant differences in clinical sensitivity was between the Beckman assay and both Genalyte and Roche assays. Convalescent plasma donor characteristics and disease symptoms did not correlate with false negative results from the Beckman and DiaSorin assays. All four tests showed high specificity (100%) and varying sensitivities (89–98%). No correlations between disease history and serology results were observed. The Genalyte Multiplex assay showed as good or better sensitivity to three other previously validated assays with FDA Emergency Use Authorizations.
Highlights
The Coronavirus Disease 2019 (COVID-19) pandemic created an urgent need for serology tests against a novel viral pathogen
Multiple companies rapidly developed assays to detect antibodies against the causative agent, SARS-CoV-2. These in vitro diagnostic tests were submitted to the United States Food and Drug Administration (FDA) for Emergency Use Authorization (EUA), which permitted their marketing
In-house developed assays were validated as laboratory developed tests (LDTs)
Summary
The Coronavirus Disease 2019 (COVID-19) pandemic created an urgent need for serology tests against a novel viral pathogen. In-house developed assays were validated as laboratory developed tests (LDTs).
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