Article
Recommendation for validation and quality assurance of non-invasive prenatal testing for foetal blood groups and implications for IVD risk classification according to EU regulations.
Vox sanguinis - 1 Feb 2022
Clausen Frederik Banch, Hellberg Åsa, Bein Gregor, Bugert Peter, Schwartz Dieter, Drnovsek Tadeja Dovc, Finning Kirstin, Guz Katarzyna, Haimila Katri, Henny Christine, O'Brien Helen, Orzinska Agnieszka, Sørensen Kirsten, Thorlacius Steinunn, Wikman Agneta, Denomme Gregory Andrew, Flegel Willy Albert, Gassner Christoph, de Haas Masja, Hyland Catherine, Ji Yanli, Lane William J, Nogués Núria, Olsson Martin L, Peyrard Thierry, van der Schoot C Ellen, Weinstock Christof, Legler Tobias
Abstract excerpt
BACKGROUND AND OBJECTIVES: Non-invasive assays for predicting foetal blood group status in pregnancy serve as valuable clinical tools in the management of pregnancies at risk of detrimental consequences due to blood group antigen incompatibility. To secure clinical applicability, assays for non-invasive prenatal testing of foetal blood groups need to follow strict rules for validation and quality assurance. Here,...
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