Is Better Standardization of Therapeutic Antibody Quality in Emerging Diseases Epidemics Possible?

Front Immunol. 2022 Feb 22:13:816159. doi: 10.3389/fimmu.2022.816159. eCollection 2022.

Abstract

During the ongoing COVID-19 epidemic many efforts have gone into the investigation of the SARS-CoV-2-specific antibodies as possible therapeutics. Currently, conclusions cannot be drawn due to the lack of standardization in antibody assessments. Here we describe an approach of establishing antibody characterisation in emergent times which would, if followed, enable comparison of results from different studies. The key component is a reliable and reproducible assay of wild-type SARS-CoV-2 neutralisation based on a banking system of its biological components - a challenge virus, cells and an anti-SARS-CoV-2 antibody in-house standard, calibrated to the First WHO International Standard immediately upon its availability. Consequently, all collected serological data were retrospectively expressed in an internationally comparable way. The neutralising antibodies (NAbs) among convalescents ranged from 4 to 2869 IU mL-1 in a significant positive correlation to the disease severity. Their decline in convalescents was on average 1.4-fold in a one-month period. Heat-inactivation resulted in 2.3-fold decrease of NAb titres in comparison to the native sera, implying significant complement activating properties of SARS-CoV-2 specific antibodies. The monitoring of NAb titres in the sera of immunocompromised COVID-19 patients that lacked their own antibodies evidenced the successful transfusion of antibodies by the COVID-19 convalescent plasma units with NAb titres of 35 IU mL-1 or higher.

Keywords: COVID-19; SARS-CoV-2; convalescent plasma; passive antibody therapy; wild-type virus neutralization assay.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • COVID-19 / epidemiology
  • COVID-19 / therapy*
  • Calibration
  • Cells, Cultured
  • Communicable Diseases, Emerging
  • Convalescence
  • Coronavirus Papain-Like Proteases / genetics
  • Coronavirus Papain-Like Proteases / immunology
  • Croatia
  • Epidemics
  • Humans
  • Immunization, Passive / methods*
  • International Cooperation
  • Neutralization Tests / methods*
  • Reference Standards
  • SARS-CoV-2 / physiology*
  • Spike Glycoprotein, Coronavirus / genetics*
  • Spike Glycoprotein, Coronavirus / immunology
  • Treatment Outcome

Substances

  • Spike Glycoprotein, Coronavirus
  • spike protein, SARS-CoV-2
  • Coronavirus Papain-Like Proteases
  • papain-like protease, SARS-CoV-2