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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.

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Title: 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.
Authors: Clausen, Frederik Banch1,2 (AUTHOR) frederik.banch.clausen@regionh.dk, Hellberg, Åsa2,3 (AUTHOR), Bein, Gregor4 (AUTHOR), Bugert, Peter5 (AUTHOR), Schwartz, Dieter6 (AUTHOR), Drnovsek, Tadeja Dovc7 (AUTHOR), Finning, Kirstin8 (AUTHOR), Guz, Katarzyna9 (AUTHOR), Haimila, Katri10 (AUTHOR), Henny, Christine11 (AUTHOR), O'Brien, Helen12 (AUTHOR), Orzinska, Agnieszka9 (AUTHOR), Sørensen, Kirsten13 (AUTHOR), Thorlacius, Steinunn14 (AUTHOR), Wikman, Agneta15 (AUTHOR), Denomme, Gregory Andrew2,16 (AUTHOR), Flegel, Willy Albert2,17 (AUTHOR), Gassner, Christoph2,18 (AUTHOR), de Haas, Masja2,19,20 (AUTHOR), Hyland, Catherine2,12,21 (AUTHOR)
Source: Vox Sanguinis. Feb2022, Vol. 117 Issue 2, p157-165. 9p. 2 Charts.
Database: Academic Search Ultimate
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Description
ISSN:00429007
DOI:10.1111/vox.13172