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

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

Acknowledgments

We extend our gratitude to the dedicated staff at MHRA, Vismederi, THSTI, Icddr,b, and Gorman Consulting for their invaluable contributions in performing the assays. We would also like to express our appreciation to Dr Mark Manak, former consultant at CEPI; Mr Vijay Zala, the project manager at CEPI-CLN; Ms Janina Hutchens, the project coordinator at CEPI-CLN, and Dr Peter Spencer, the quality manager at CEPI-CLN, for their support throughout this study.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

The work was supported by the CEPI.