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

Abstract

ABSTRACTTo 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
• standardization
• immunological assays
• SARS-CoV-2 pandemic
• vaccine efficacy