Driving consistency: CEPI-Centralized Laboratory Network's conversion factor initiative for SARS-CoV-2 clinical assays used for efficacy assessment of COVID vaccines

Hum Vaccin Immunother. 2024 Dec 31;20(1):2344249. doi: 10.1080/21645515.2024.2344249. Epub 2024 May 6.

Abstract

To date, thousands of SARS-CoV-2 samples from many vaccine developers have been tested within the CEPI-Centralized Laboratory Network. To convert data from each clinical assay to international standard units, the WHO international standard and the CEPI standard generated by the Medicines and Healthcare products Regulatory Agency were run in multiple facilities to determine the conversion factor for each assay. Reporting results in international units advances global understanding of SARS-CoV-2 immunity and vaccine efficacy, enhancing the quality, reliability, and utility of clinical assay data.

Keywords: CEPI-CLN; SARS-CoV-2 pandemic; immunological assays; standardization; vaccine efficacy.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • COVID-19 Vaccines* / immunology
  • COVID-19* / prevention & control
  • Clinical Laboratory Techniques / methods
  • Clinical Laboratory Techniques / standards
  • Humans
  • Reproducibility of Results
  • SARS-CoV-2* / immunology
  • Vaccine Efficacy
  • World Health Organization

Substances

  • COVID-19 Vaccines

Grants and funding

The work was supported by the CEPI.