Target specific serologic analysis of COVID-19 convalescent plasma

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.

Prevalence and correlates of SARS-CoV-2 seropositivity among people who inject drugs in the San Diego-Tijuana border region

“…Serology was conducted by Genalyte® (San Diego, CA), using their Maverick™ Multi-Antigen Serology Panel [ 21 ] that detects IgG and IgM antibodies to five SARS-CoV-2 antigens (Nucleocapsid, Spike S1-S2, Spike S1, Spike S1-RBD, Spike S2) within a multiplex format based on photonic ring resonance. A machine learning algorithm was used to call results using the Random Forest Ensemble method with 3000 decision trees [ 22 ].…”

Development and evaluation of a low cost IgG ELISA test based in RBD protein for COVID-19

“…A recent analysis of the performance of four serology assays for COVID-19 based on the RBD domain resulted in sensitivity and specificity values of 98–87% and 100%, respectively ( Ikegami et al, 2021 ). The study of Ma and collaborators has shown a better diagnostic accuracy of an RBD-based test than that of an N-based test ( Ma et al, 2020 ), with a sensitivity of 100% 16 days after disease onset for this the RBD-based test.…”

Hospitalization Requiring Intensive Care Unit Due to SARS-CoV-2 Infection Correlated With IgM Depression and IgG Elevation

“…Results are reported in genalyte response units (GRUs). The assay reports an overall sensitivity of 98% and specificity of 100%, as good as or better than three other previously validated SARS-CoV-2 serologic assays [ 7 ].…”