Correlation of SARS-CoV-2 Neutralizing Antibodies to an Automated Chemiluminescent Serological Immunoassay

J Appl Lab Med. 2021 Mar 1;6(2):491-495. doi: 10.1093/jalm/jfaa195.

Abstract

Introduction: Neutralizing antibodies (NAbs) are capable of binding to a virus to render it incapable of infection. The ability of commercially available SARS-CoV-2 serological tests to detect NAbs has not been widely reported. We sought to correlate the antibodies detected by an automated chemiluminescent immunoassay with NAbs.

Methods: Residual serum samples from 35 patients that had a positive antibody test using the LIAISON® SARS-CoV-2 S1/S2 IgG chemiluminescent immunoassay and 2 antibody-negative control sera were tested for NAbs using a plaque reduction neutralization test (PRNT).

Results: NAbs were detected in 66% (23/35) of the antibody-positive samples. The immunoassay signal value ranged from 21.7 to 131.3 AU/mL (median, 90.5) with significant correlation between it and the PRNT (r = 0.61, P = 0.002). In the samples without NAbs, the immunoassay signal ranged from 16.3 to 66.2 AU/mL (median, 27.2). An immunoassay signal cutoff of >41 AU/mL was 91% sensitive and 92% specific for the detection of NAbs.

Discussion: It is important that correlates of immunity to SARS-CoV-2 be identified and NAbs are considered to be central indicators of such. PRNT is the gold-standard test for identifying NAbs but it cannot be used for large-scale testing of populations. It is necessary to establish relationships between it and widely used commercial serological assays for SARS-CoV-2.

Keywords: SARS-CoV-2; neutralizing antibodies; novel coronavirus; serology.

Publication types

  • Evaluation Study

MeSH terms

  • Antibodies, Neutralizing / immunology
  • Antibodies, Neutralizing / isolation & purification*
  • Antibodies, Viral / immunology
  • Antibodies, Viral / isolation & purification*
  • COVID-19 / blood
  • COVID-19 / diagnosis*
  • COVID-19 / immunology
  • COVID-19 / virology
  • COVID-19 Serological Testing / instrumentation
  • COVID-19 Serological Testing / methods
  • COVID-19 Serological Testing / standards*
  • COVID-19 Serological Testing / statistics & numerical data
  • Humans
  • Immunoglobulin G / immunology
  • Immunoglobulin G / isolation & purification
  • Luminescent Measurements / instrumentation
  • Luminescent Measurements / standards
  • Luminescent Measurements / statistics & numerical data
  • Neutralization Tests / standards
  • Neutralization Tests / statistics & numerical data
  • Reagent Kits, Diagnostic / standards
  • SARS-CoV-2 / immunology
  • SARS-CoV-2 / isolation & purification*
  • Sensitivity and Specificity

Substances

  • Antibodies, Neutralizing
  • Antibodies, Viral
  • Immunoglobulin G
  • Reagent Kits, Diagnostic