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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AuthorsClausen, Frederik Banch
Drnovsek, Tadeja Dovc
Denomme, Gregory Andrew
Flegel, Willy Albert
de Haas, Masja
Lane, William J
Olsson, Martin L
van der Schoot, C Ellen
MetadataShow full item record
CitationClausen FB, Hellberg Å, Bein G, Bugert P, Schwartz D, Drnovsek TD, Finning K, Guz K, Haimila K, Henny C, O'Brien H, Orzinska A, Sørensen K, Thorlacius S, Wikman A, Denomme GA, Flegel WA, Gassner C, de Haas M, Hyland C, Ji Y, Lane WJ, Nogués N, Olsson ML, Peyrard T, van der Schoot CE, Weinstock C, Legler T. 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 Sang. 2021 Jun 21. doi: 10.1111/vox.13172.
AbstractBackground 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, we present a multi-national position paper with specific recommendations for validation and quality assurance for such assays and discuss their risk classification according to EU regulations. Materials and methods: We reviewed the literature covering validation for in-vitro diagnostic (IVD) assays in general and for non-invasive foetal RHD genotyping in particular. Recommendations were based on the result of discussions between co-authors. Results: In relation to Annex VIII of the In-Vitro-Diagnostic Medical Device Regulation 2017/746 of the European Parliament and the Council, assays for non-invasive prenatal testing of foetal blood groups are risk class D devices. In our opinion, screening for targeted anti-D prophylaxis for non-immunized RhD negative women should be placed under risk class C. To ensure high quality of non-invasive foetal blood group assays within and beyond the European Union, we present specific recommendations for validation and quality assurance in terms of analytical detection limit, range and linearity, precision, robustness, pre-analytics and use of controls in routine testing. With respect to immunized women, different requirements for validation and IVD risk classification are discussed. Conclusion: These recommendations should be followed to ensure appropriate assay performance and applicability for clinical use of both commercial and in-house assays. Keywords: EU; HDFN; blood group; cell-free DNA; foetal RHD genotyping; quality assurance; validation.
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Rights© 2021 International Society of Blood Transfusion.
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