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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

Clausen, Frederik Banch ; Hellberg, Åsa LU ; Bein, Gregor ; Bugert, Peter ; Schwartz, Dieter ; Drnovsek, Tadeja Dovc ; Finning, Kirstin ; Guz, Katarzyna ; Haimila, Katri and Henny, Christine , et al. (2022) In Vox Sanguinis 117(2). p.157-165
Abstract

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... (More)

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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
blood group, cell-free DNA, EU, foetal RHD genotyping, HDFN, quality assurance, validation
in
Vox Sanguinis
volume
117
issue
2
pages
157 - 165
publisher
Wiley-Blackwell
external identifiers
  • pmid:34155647
  • scopus:85108297969
ISSN
0042-9007
DOI
10.1111/vox.13172
language
English
LU publication?
yes
id
7e1d8a23-ab5f-4d1d-ae93-89c066230a46
date added to LUP
2021-07-12 14:14:00
date last changed
2024-04-20 08:40:10
@article{7e1d8a23-ab5f-4d1d-ae93-89c066230a46,
  abstract     = {{<p>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.</p>}},
  author       = {{Clausen, Frederik Banch and Hellberg, Åsa and Bein, Gregor and Bugert, Peter and Schwartz, Dieter and Drnovsek, Tadeja Dovc and Finning, Kirstin and Guz, Katarzyna and Haimila, Katri and Henny, Christine and O'Brien, Helen and Orzinska, Agnieszka and Sørensen, Kirsten and Thorlacius, Steinunn and Wikman, Agneta and Denomme, Gregory Andrew and Flegel, Willy Albert and Gassner, Christoph and de Haas, Masja and Hyland, Catherine and Ji, Yanli and Lane, William J. and Nogués, Núria and Olsson, Martin L. and Peyrard, Thierry and van der Schoot, C. Ellen and Weinstock, Christof and Legler, Tobias}},
  issn         = {{0042-9007}},
  keywords     = {{blood group; cell-free DNA; EU; foetal RHD genotyping; HDFN; quality assurance; validation}},
  language     = {{eng}},
  number       = {{2}},
  pages        = {{157--165}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{Vox Sanguinis}},
  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}},
  url          = {{http://dx.doi.org/10.1111/vox.13172}},
  doi          = {{10.1111/vox.13172}},
  volume       = {{117}},
  year         = {{2022}},
}