In vitro diagnostics for screening the blood supply: the new European regulation for IVD and the WHO IVD prequalification programme

Blood transfusion remains a routine life-saving medical procedure that helps replace blood lost due to surgery, injury or disease. The quality of transfused blood is crucial in this process as blood donors must be free of transfusion-transmissible infections and donated blood should be compatible to that of the recipient. The quality of donated blood could be affected by the quality of in vitro diagnostic medical devices (IVDs) used in the screening process. Consequently, the need for high-quality, safe and well-performing IVDs for use in transfusion medicine arises, accompanied by the need for tight regulations in this domain. In the European Union, the new IVD Regulation will replace the existing IVD Directive within a five-year transitional period. Manufacturers of IVDs are expected to fully comply with the new Regulation by 26 May 2022. In this review, we address the major differences relating to marketing authorization and testing between this new Regulation and its predecessor. We further present the main elements of the prequalification assessment introduced by the WHO for IVDs, including disease-specific IVDs for blood screening laboratories

Implementation of Blood and Blood Product Regulation Training Workshop, South Africa

The training workshop on Implementation of Blood and Blood Product Regulation was organised and co-hosted by the Paul-Ehrlich -Institut Global Health Protection Program BloodTrain and the Africa Society for Blood Transfusion (AfSBT) from the 20th to the 22nd of August 2019. This was aimed at strengthening the capacity of African countries in developing and implementing regulatory systems for blood. Over thirty participants from countries across the African continent came together in Johannesburg, South Africa and shared knowledge and experiences among themselves and also with experts from the BloodTrain, Africa Society for Blood Transfusion (AfSBT), World Health Organization (WHO) and the New Partnership for Africa`s Development (NEPAD). The workshop addressed a wide range of topics ranging from standards in transfusion, clinical practice, regulatory framework for blood, WHO guidelines related to blood regulation, haemovigilance and regulatory oversight of associated Medical Devices In-vitro Diagnostics. In addition to the context and motivation of the workshop, this report summarises the key content covered throughout the workshop and recommendations for further improvement.Un atelier de formation portant sur la mise en oeuvre de la réglementation du sang et des produits sanguin s a été co-organisé par le programme de protection de la santé mondiale Paul-Ehrlich-Institut BloodTrain et la Société Africaine de Transfusion Sanguine (SATS) du 20 au 22 août 2019. Il visait à renforcer la capacité des pays africains à élaborer et à mettre en oeuvre des systèmes de réglementation pour le sang. Plus de trente participants de pays du continent africain se sont réunis à Johannesburg, en Afrique du Sud et ont partagé leurs connaissances et leurs expériences entre eux ainsi qu'avec des experts de BloodTrain, de la SATS, de l'Organisation Mondiale de la Santé (OMS) et du Nouveau partenariat pour le développement de l'Afrique (NEPAD). L'atelier a abordé un large éventail de sujets, allant des normes de transfusion, de la pratique clinique, du cadre réglementaire pour le sang, des directives de l'OMS relatives à la régulation du sang, à l'hémovigilance et à la surveillance réglementai re des diagnostics in vitro des dispositifs médicaux associés. En plus du contexte et de la motivation de l'atelier, ce rapport résume le contenu clé couvert tout au long de l'atelier et des recommandations pour de nouvelles améliorations

Cyclovirus CyCV-VN species distribution is not limited to Vietnam and extends to Africa

Cycloviruses, small ssDNA viruses of the Circoviridae family, have been identified in the cerebrospinal fluid from symptomatic human patients. One of these species, cyclovirus-Vietnam (CyCV-VN), was shown to be restricted to central and southern Vietnam. Here we report the detection of CyCV-VN species in stool samples from pigs and humans from Africa, far beyond their supposed limited geographic distribution