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Standardized immunological assays for assessing COVID-19 vaccines by the CEPI-Centralized Laboratory Network.
NPJ Vaccines
July 2024
CEPI, Skøyen Atrium, Askekroken 11, Oslo, Norway.
The CEPI Centralized Laboratory Network implemented key steps in the transfer and monitoring of the developed immunological SARS-CoV-2 assays to ensure standardization across all the facilities of the network. This comprehensive evaluation reinforces the reliability of the generated data and establishes a solid foundation for a standardized approach, enabling precise inter-laboratory comparisons and contributing to the overall integrity of our network's clinical results. Herein, we will provide a brief elaboration on the specific measures and procedures implemented to standardize the transfer of assays across our network.
View Article and Find Full Text PDFDriving 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
December 2024
Laboratory Research and Innovations, CEPI, Oslo, Norway.
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.
View Article and Find Full Text PDFUnifying global efforts by CEPI's centralized laboratory network.
Front Immunol
April 2024
Laboratory Research and Innovations (LRI), CEPI, Oslo, Norway.
Standardised quantitative assays for anti-SARS-CoV-2 immune response used in vaccine clinical trials by the CEPI Centralized Laboratory Network: a qualification analysis.
Lancet Microbe
March 2024
Coalition for Epidemic Preparedness Innovations (CEPI), Oslo, Norway.
Background: Accurate quantitation of immune markers is crucial for ensuring reliable assessment of vaccine efficacy against infectious diseases. This study was designed to confirm standardised performance of SARS-CoV-2 assays used to evaluate COVID-19 vaccine candidates at the initial seven laboratories (in North America, Europe, and Asia) of the Coalition for Epidemic Preparedness Innovations (CEPI) Centralized Laboratory Network (CLN).
Methods: Three ELISAs (pre-spike protein, receptor binding domain, and nucleocapsid), a microneutralisation assay (MNA), a pseudotyped virus-based neutralisation assay (PNA), and an IFN-γ T-cell ELISpot assay were developed, validated or qualified, and transferred to participating laboratories.
The CEPI centralized laboratory network for COVID-19 will help prepare for future outbreaks.
Nat Med
November 2023
Coalition for Epidemic Preparedness Innovations, Oslo, Norway.
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