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

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

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-inva...

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Bibliographic Details
Main Authors: Bein, G. (Author), Bugert, P. (Author), Clausen, F.B (Author), de Haas, M. (Author), Denomme, G.A (Author), Drnovsek, T.D (Author), Finning, K. (Author), Flegel, W.A (Author), Gassner, C. (Author), Guz, K. (Author), Haimila, K. (Author), Hellberg, Å (Author), Henny, C. (Author), Hyland, C. (Author), Ji, Y. (Author), Lane, W.J (Author), Legler, T. (Author), Nogués, N. (Author), O'Brien, H. (Author), Olsson, M.L (Author), Orzinska, A. (Author), Peyrard, T. (Author), Schwartz, D. (Author), Sørensen, K. (Author), Thorlacius, S. (Author), van der Schoot, C.E (Author), Weinstock, C. (Author), Wikman, A. (Author)
Format: Article
Language:English
Published: John Wiley and Sons Inc 2022
Subjects:
blood donor
blood group
blood group antigen
Blood Group Antigens
blood group rhesus system
blood group typing
blood transfusion
cell therapy
cell-free DNA
circulating free DNA
controlled study
diagnostic accuracy
diagnostic test
DNA extraction
edetic acid
erythrocyte transfusion
EU
European Union
false negative result
female
Female
Fetal Blood
fetus
Fetus
fetus blood
foetal RHD genotyping
genetics
genotype
Genotype
genotyping
HDFN
hemagglutination test
human
Humans
limit of detection
medical device regulation
noninvasive prenatal testing
pregnancy
Pregnancy
prenatal diagnosis
Prenatal Diagnosis
quality assurance
quality control
real time polymerase chain reaction
Review
rhesus D antibody
Rh-Hr Blood-Group System
risk assessment
validation
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