Independent Side-by-Side Validation and Comparison of 4 Serological Platforms for SARS-CoV-2 Antibody Testing

J Infect Dis. 2021 Mar 3;223(5):796-801. doi: 10.1093/infdis/jiaa656.

Abstract

Highly sensitive and specific platforms for the detection of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies are becoming increasingly important for evaluating potential SARS-CoV-2 convalescent plasma donors, studying the spread of SARS-CoV-2 infections, and identifying individuals with seroconversion. This study provides a comparative validation of 4 anti-SARS-CoV-2 platforms. A unique feature of the study is the use of a representative cohort of convalescent patients with coronavirus disease 2019 and a mild to moderate disease course. All platforms showed significant correlations with a SARS-CoV-2 plaque reduction neutralization test, with highest sensitivities for the Euroimmun and the Roche platforms, suggesting their preferential use for screening persons at increased risk of SARS-CoV-2 infections.

Keywords: CLIA; CMIA; ECLIA; ELISA; SARS-CoV-2; neutralization test; nucleocapsid; spike.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • COVID-19 / therapy*
  • COVID-19 Serological Testing / methods
  • COVID-19 Serological Testing / standards*
  • Case-Control Studies
  • Cohort Studies
  • Female
  • Humans
  • Immunization, Passive / standards
  • Male
  • Middle Aged
  • Neutralization Tests
  • Predictive Value of Tests
  • SARS-CoV-2 / immunology*
  • Sensitivity and Specificity
  • Tissue Donors
  • Young Adult

Supplementary concepts

  • COVID-19 serotherapy