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-Reference-Cited by-同舟云学术

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

Published:2021-06-21 Issue: Volume: Page:
ISSN:0042-9007
Container-title:Vox Sanguinis
language:en
Short-container-title:Vox Sanguinis

Author:

Clausen Frederik Banch¹²^ORCID,Hellberg Åsa²³^ORCID,Bein Gregor⁴,Bugert Peter⁵,Schwartz Dieter⁶,Drnovsek Tadeja Dovc⁷,Finning Kirstin⁸,Guz Katarzyna⁹,Haimila Katri¹⁰^ORCID,Henny Christine¹¹,O'Brien Helen¹²,Orzinska Agnieszka⁹,Sørensen Kirsten¹³,Thorlacius Steinunn¹⁴,Wikman Agneta¹⁵^ORCID,Denomme Gregory Andrew²¹⁶^ORCID,Flegel Willy Albert²¹⁷^ORCID,Gassner Christoph²¹⁸,Haas Masja²¹⁹²⁰,Hyland Catherine²¹²²¹,Ji Yanli²²²^ORCID,Lane William J.²²³²⁴^ORCID,Nogués Núria²²⁵,Olsson Martin L.²³²⁶^ORCID,Peyrard Thierry²²⁷,Schoot C. Ellen²²⁸,Weinstock Christof²²⁹,Legler Tobias³⁰

Affiliation:

1. Laboratory of Blood Genetics, Department of Clinical Immunology Copenhagen University Hospital Copenhagen Denmark

2. cfDNA subgroup from the International Society of Blood Transfusion (ISBT) Working Party on Red Cell Immunogenetics and Blood Group Terminology (RCIBGT) Amsterdam The Netherlands

3. Department of Clinical Immunology and Transfusion Medicine Office for Medical Services Region Skåne Sweden

4. Institute for Clinical Immunology and Transfusion Medicine Justus‐Liebig‐University Giessen Germany

5. Institute of Transfusion Medicine and Immunology Heidelberg University, Medical Faculty Mannheim, German Red Cross Blood Service Baden Württemberg – Hessen Mannheim Germany

6. Department of Blood Group Serology and Transfusion Medicine Medical University of Vienna Vienna Austria

7. Blood Transfusion Centre of Slovenia Ljubljana Slovenia

8. National Health Service Blood and Transplant International Blood Group Reference Laboratory UK

9. Institute of Hematology and Transfusion Medicine Warsaw Poland

10. Finnish Red Cross Blood Service Helsinki Finland

11. Interregional Blood Transfusion SRC Berne Switzerland

12. Clinical Services and Research Australian Red Cross Lifeblood Brisbane Australia

13. Department of Immunology and Transfusion Medicine Oslo University Hospital Oslo Norway

14. The Blood Bank Landspitali University Hospital Reykjavik Iceland

15. Clinical Immunology and Transfusion Medicine Karolinska University Hospital and CLINTEC Karolinska Institutet Stockholm Sweden

16. Versiti Blood Research Institute and Diagnostic Laboratories Milwaukee Wisconsin USA

17. Department of Transfusion Medicine NIH Clinical Center, National Institutes of Health Bethesda Maryland USA

18. Institute for Translational Medicine Private University in the Principality of Liechtenstein Triesen Liechtenstein

19. Department of Immunohaematology Diagnostic Services Sanquin Diagnostic Services and Sanquin Research Amsterdam The Netherlands

20. Department of Haematology Leiden University Medical Center Leiden The Netherlands

21. School of Biomedical Sciences Queensland University of Technology Brisbane Queensland Australia

22. Guangzhou Blood Center Institute of Clinical Blood Transfusion Guangzhou China

23. Department of Pathology Brigham and Women's Hospital Boston Massachusetts USA

24. Harvard Medical School Boston Massachusetts USA

25. Immunohematology Laboratory Blood and Tissue Bank Barcelona Spain

26. Department of Laboratory Medicine Lund University Lund Sweden

27. Institut National de la Transfusion Sanguine Centre National de Référence pour les Groupes Sanguins Paris France

28. Department of Experimental Immunohematology Sanquin Research Amsterdam The Netherlands

29. Institute of Clinical Transfusion Medicine and Immunogenetics Ulm German Red Cross Blood Service Baden‐Württemberg‐Hessen, and Institute of Transfusion Medicine, University of Ulm Ulm Germany

30. Department of Transfusion Medicine University Medical Center Göttingen Göttingen Germany

Publisher

Wiley

Subject

Hematology,General Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/vox.13172

Reference63 articles.

1. Noninvasive Fetal Blood Group Typing

2. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision;2010/227/EU;Off J,2017

3. Haemolytic disease of the fetus and newborn

4. Anti-D prophylaxis: past, present and future

5. Routine administration of Anti-D: the ethical case for offering pregnant women fetal RHDgenotyping and a review of policy and practice

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