作者
Herbert A Mbunkah, Chancelar Kafere, Washington Samukange, Micha Nübling, Jens Reinhardt
发表日期
2022/12
来源
Transfusion Medicine
卷号
32
期号
6
页码范围
467-474
出版商
Blackwell Publishing Ltd
简介
Objectives
The online workshop on IVD regulation was performed to broaden the understanding of the technical documentation needed for IVD licensing and the strategies to asses it.
Background
Testing of blood donors and donations significantly reduces the risk of transmitting transfusion‐transmissible infections. Many test systems are commercially available, but not all meet the recommended sensitivity and specificity standards. Many African countries either lack functional structures for the regulation of IVDs this poses a threat to the quality of the blood supply.
Materialsand Methods
The Paul‐Ehrlich‐Institut BloodTrain organised an online workshop in September 2021 to introduce staff from several National Regulatory Authorities (NRAs) in Africa to the regulation of IVD and the technical information that need to be provided by the manufacturers of blood screening IVD. Their evaluation was trained in …
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