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

IF 4.1 4区 医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Human Vaccines & Immunotherapeutics Pub Date : 2024-12-31 Epub Date: 2024-05-06 DOI:10.1080/21645515.2024.2344249
Ali Azizi, Gathoni Kamuyu, Deborah Ogbeni, Philipa Levesque-Damphousse, Daniel Knott, Luc Gagnon, Steven Phay-Tran, Bethan Hussey, Pamela Proud, Sue Charlton, Carolyn Clark, Valentina Bernasconi
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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.

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推动一致性:CEPI - 集中实验室网络用于 COVID 疫苗有效性评估的 SARS-CoV-2 临床检测转换系数倡议。
迄今为止,CEPI-集中实验室网络已对来自许多疫苗开发商的数千份 SARS-CoV-2 样品进行了检测。为了将每项临床化验的数据转换成国际标准单位,我们在多个设施中运行了世界卫生组织的国际标准和药品与保健品监管局制定的 CEPI 标准,以确定每项化验的转换系数。以国际标准单位报告结果可促进全球对 SARS-CoV-2 免疫力和疫苗效力的了解,提高临床化验数据的质量、可靠性和实用性。
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来源期刊
Human Vaccines & Immunotherapeutics
Human Vaccines & Immunotherapeutics BIOTECHNOLOGY & APPLIED MICROBIOLOGY-IMMUNOLOGY
CiteScore
7.90
自引率
8.30%
发文量
489
审稿时长
3-6 weeks
期刊介绍: (formerly Human Vaccines; issn 1554-8619) Vaccine research and development is extending its reach beyond the prevention of bacterial or viral diseases. There are experimental vaccines for immunotherapeutic purposes and for applications outside of infectious diseases, in diverse fields such as cancer, autoimmunity, allergy, Alzheimer’s and addiction. Many of these vaccines and immunotherapeutics should become available in the next two decades, with consequent benefit for human health. Continued advancement in this field will benefit from a forum that can (A) help to promote interest by keeping investigators updated, and (B) enable an exchange of ideas regarding the latest progress in the many topics pertaining to vaccines and immunotherapeutics. Human Vaccines & Immunotherapeutics provides such a forum. It is published monthly in a format that is accessible to a wide international audience in the academic, industrial and public sectors.
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