Target specific serologic analysis of COVID-19 convalescent plasma

PLoS One. 2021 Apr 28;16(4):e0249938. doi: 10.1371/journal.pone.0249938. eCollection 2021.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antibodies, Viral / immunology
  • COVID-19 / immunology*
  • COVID-19 / therapy*
  • COVID-19 Serotherapy
  • Female
  • Humans
  • Immunization, Passive / methods
  • Immunoglobulin G / immunology
  • Male
  • Middle Aged
  • Plasma / chemistry
  • Plasma / immunology
  • SARS-CoV-2 / immunology*
  • SARS-CoV-2 / pathogenicity
  • Sensitivity and Specificity
  • Serologic Tests / methods

Substances

  • Antibodies, Viral
  • Immunoglobulin G

Grants and funding

This work was supported by private donations to the NorthShore Foundation as well as institutional support from Genalyte and NorthShore. The funders provided support in the form of salaries for authors MHM, RH, and HF (Genalyte) as well as TJG, HKL, JK, RCB, and SD (NorthShore), but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section. Procurement and testing of samples collected prior to the year 2020 was paid for by Genalyte, Inc. NorthShore University HealthSystem paid for testing of convalescent plasma donor samples on the three in-house assays, however it was not charged for testing on Genalyte’s assay.