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

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 Healthc...

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Published in:Human vaccines & immunotherapeutics 2024-12, Vol.20 (1), p.2344249
Main Authors: Azizi, Ali, Kamuyu, Gathoni, Ogbeni, Deborah, Levesque-Damphousse, Philipa, Knott, Daniel, Gagnon, Luc, Phay-Tran, Steven, Hussey, Bethan, Proud, Pamela, Charlton, Sue, Clark, Carolyn, Bernasconi, Valentina
Format: Article
Language:English
Subjects:
CEPI-CLN
Clinical Laboratory Techniques - methods
Clinical Laboratory Techniques - standards
COVID-19 - prevention & control
COVID-19 Vaccines - immunology
Humans
immunological assays
Reproducibility of Results
SARS-CoV-2 - immunology
SARS-CoV-2 pandemic
standardization
Vaccine Efficacy
World Health Organization
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container_title Human vaccines & immunotherapeutics
container_volume 20
creator Azizi, Ali
Kamuyu, Gathoni
Ogbeni, Deborah
Levesque-Damphousse, Philipa
Knott, Daniel
Gagnon, Luc
Phay-Tran, Steven
Hussey, Bethan
Proud, Pamela
Charlton, Sue
Clark, Carolyn
Bernasconi, Valentina
description 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.
doi_str_mv 10.1080/21645515.2024.2344249
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subjects CEPI-CLN
Clinical Laboratory Techniques - methods
Clinical Laboratory Techniques - standards
COVID-19 - prevention & control
COVID-19 Vaccines - immunology
Humans
immunological assays
Reproducibility of Results
SARS-CoV-2 - immunology
SARS-CoV-2 pandemic
standardization
Vaccine Efficacy
World Health Organization
title Driving consistency: CEPI-Centralized Laboratory Network's conversion factor initiative for SARS-CoV-2 clinical assays used for efficacy assessment of COVID vaccines
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