ReviewVox sanguinis2022
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.
Review in Vox sanguinis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
8 citing papers in PubMed, 21 citations in OpenAlex.
- Routine use of a spike-in DNA in-process control for foetal RHD genotyping: Testing the real-world effectiveness of this 'canary'.Vox sanguinis · 2026Article
- A Validation Approach for Determining Fetal Blood Groups Non-Invasively by High-Sensitive Next-Generation Sequencing.Journal of clinical medicine · 2025Article
- Noninvasive fetal antigen genotyping: Results from a survey on the status of clinical implementation.Vox sanguinis · 2025Article
- Noninvasive fetal blood group antigen genotyping.Blood transfusion = Trasfusione del sangue · 2025Review
- FetalBiomedicines · 2023Article
- Single-exon approach to non-invasive fetal RHD screening in early pregnancy: An update after 10 years' experience.Vox sanguinis · 2022Article
- Noninvasive Prenatal Testing in Immunohematology-Clinical, Technical and Ethical Considerations.Journal of clinical medicine · 2022Review
- Laboratory Monitoring of Mother, Fetus, and Newborn in Hemolytic Disease of Fetus and Newborn.Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie · 2021Review
Corrections and comments
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Authors and funding
28 authors at 20 institutions in 18 countries.
Funding
Abstract
BACKGROUND AND
objectivesNon-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
methodsWe 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.
resultsIn 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.
conclusionThese 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.