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.
Frederik Banch ClausenÅsa HellbergGregor BeinPeter BugertDieter SchwartzTadeja Dovc DrnovsekKirstin FinningKatarzyna GuzKatri HaimilaChristine HennyHelen O'BrienAgnieszka OrzinskaKirsten SørensenSteinunn ThorlaciusAgneta WikmanGregory Andrew DenommeWilly Albert FlegelChristoph GassnerMasja de HaasCatherine HylandYanli JiWilliam J LaneNúria NoguésMartin L OlssonThierry PeyrardC Ellen van der SchootChristof WeinstockTobias LeglerPublished in: Vox sanguinis (2021)
These recommendations should be followed to ensure appropriate assay performance and applicability for clinical use of both commercial and in-house assays.