TY - JOUR
T1 - 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
AU - Clausen, Frederik Banch
AU - Hellberg, Åsa
AU - Bein, Gregor
AU - Bugert, Peter
AU - Schwartz, Dieter
AU - Drnovsek, Tadeja Dovc
AU - Finning, Kirstin
AU - Guz, Katarzyna
AU - Haimila, Katri
AU - Henny, Christine
AU - O'Brien, Helen
AU - Orzinska, Agnieszka
AU - Sørensen, Kirsten
AU - Thorlacius, Steinunn
AU - Wikman, Agneta
AU - Denomme, Gregory Andrew
AU - Flegel, Willy Albert
AU - Gassner, Christoph
AU - de Haas, Masja
AU - Hyland, Catherine
AU - Ji, Yanli
AU - Lane, William J.
AU - Nogués, N. ria
AU - Olsson, Martin L.
AU - Peyrard, Thierry
AU - van der Schoot, C. Ellen
AU - Weinstock, Christof
AU - Legler, Tobias
N1 - Publisher Copyright: © 2021 International Society of Blood Transfusion.
PY - 2021
Y1 - 2021
N2 - 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, 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.
AB - 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, 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.
KW - EU
KW - HDFN
KW - blood group
KW - cell-free DNA
KW - foetal RHD genotyping
KW - quality assurance
KW - validation
UR - http://www.scopus.com/inward/record.url?scp=85108297969&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/vox.13172
DO - https://doi.org/10.1111/vox.13172
M3 - Review article
C2 - 34155647
SN - 0042-9007
JO - Vox sanguinis
JF - Vox sanguinis
ER -