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Recommendation for ...
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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- Clausen, Frederik Banch (författare)
- Copenhagen University Hospital
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- Hellberg, Åsa (författare)
- Region Skåne
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- Bein, Gregor (författare)
- University Hospital Giessen and Marburg
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- Bugert, Peter (författare)
- Heidelberg University
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- Schwartz, Dieter (författare)
- Medical University of Vienna
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Drnovsek, Tadeja Dovc (författare)
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- Finning, Kirstin (författare)
- International Blood Group Reference Laboratory
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- Guz, Katarzyna (författare)
- Institute of Haematology and Transfusion Medicine, Warsaw
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- Haimila, Katri (författare)
- Finnish Red Cross Blood Transfusion Service
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Henny, Christine (författare)
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- O'Brien, Helen (författare)
- Australian Red Cross
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- Orzinska, Agnieszka (författare)
- Institute of Haematology and Transfusion Medicine, Warsaw
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- Sørensen, Kirsten (författare)
- Oslo university hospital
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- Thorlacius, Steinunn (författare)
- National University Hospital of Iceland
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- Wikman, Agneta (författare)
- Karolinska Institutet,Karolinska University Hospital
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Denomme, Gregory Andrew (författare)
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- Flegel, Willy Albert (författare)
- National Institutes Of Health Clinical Center
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Gassner, Christoph (författare)
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- de Haas, Masja (författare)
- Leiden University Medical Centre,Sanquin Diagnostic Services
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- Hyland, Catherine (författare)
- Australian Red Cross,Queensland University of Technology
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Ji, Yanli (författare)
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- Lane, William J. (författare)
- Brigham and Women's Hospital / Harvard Medical School
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Nogués, Núria (författare)
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- Olsson, Martin L. (författare)
- Lund University,Lunds universitet,Avdelningen för hematologi och transfusionsmedicin,Institutionen för laboratoriemedicin,Medicinska fakulteten,Transfusionsmedicin,Forskargrupper vid Lunds universitet,Division of Hematology and Transfusion Medicine,Department of Laboratory Medicine,Faculty of Medicine,Transfusion Medicine,Lund University Research Groups,Region Skåne
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- Peyrard, Thierry (författare)
- Institut National de la Transfusion Sanguine (INTS)
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van der Schoot, C. Ellen (författare)
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- Weinstock, Christof (författare)
- University of Ulm
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- Legler, Tobias (författare)
- University Medical Center Göttingen
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(creator_code:org_t)
- 2021-06-21
- 2022
- Engelska.
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Ingår i: Vox Sanguinis. - : Wiley. - 0042-9007 .- 1423-0410. ; 117:2, s. 157-165
- Relaterad länk:
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http://dx.doi.org/10...
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https://onlinelibrar...
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https://lup.lub.lu.s...
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https://doi.org/10.1...
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http://kipublication...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Hematologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Hematology (hsv//eng)
Nyckelord
- blood group
- cell-free DNA
- EU
- foetal RHD genotyping
- HDFN
- quality assurance
- validation
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- Av författaren/redakt...
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Clausen, Frederi ...
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Hellberg, Åsa
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Bein, Gregor
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Bugert, Peter
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Schwartz, Dieter
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Drnovsek, Tadeja ...
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visa fler...
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Finning, Kirstin
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Guz, Katarzyna
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Haimila, Katri
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Henny, Christine
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O'Brien, Helen
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Orzinska, Agnies ...
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Sørensen, Kirste ...
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Thorlacius, Stei ...
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Wikman, Agneta
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Denomme, Gregory ...
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Flegel, Willy Al ...
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Gassner, Christo ...
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de Haas, Masja
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Hyland, Catherin ...
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Ji, Yanli
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Lane, William J.
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Nogués, Núria
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Olsson, Martin L ...
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Peyrard, Thierry
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van der Schoot, ...
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Weinstock, Chris ...
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Legler, Tobias
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Hematologi
- Artiklar i publikationen
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Vox Sanguinis
- Av lärosätet
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Lunds universitet
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Karolinska Institutet