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The Capital Region of Denmark - a part of Copenhagen University Hospital
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Noninvasive fetal RHD genotyping to guide targeted anti-D prophylaxis-an external quality assessment workshop

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  • Noninvasive Fetal RHD Genotyping EQA2017 Working Group
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BACKGROUND AND OBJECTIVES: Fetal RHD genotyping of cell-free fetal DNA from RhD-negative pregnant women can be used to guide targeted antenatal and postnatal anti-D prophylaxis for the prevention of RhD immunization. To assure the quality of clinical testing, we conducted an external quality assessment workshop with the participation of 28 laboratories.

MATERIALS AND METHODS: Aliquots of pooled maternal plasma were sent to each laboratory. One sample was positive, and the second sample was negative for fetal RHD, verified by pre-workshop testing using quantitative real-time PCR (qPCR) analysis of RHD exons 4, 5, 7 and 10. Plasma samples were shipped at room temperature. A reporting scheme was supplied for data collection, including questions regarding the methodological setup, results and clinical recommendations. Different methodological approaches were used, all employing qPCR with a total of eight different combinations of RHD exon targets. The samples were tested blindly.

RESULTS: Fetal RHD genotyping was performed with no false-negative and no false-positive results. One inconclusive result was reported for the RHD-positive sample, and four inconclusive results were reported for the RHD-negative sample. All clinical conclusions were satisfactory.

CONCLUSION: This external quality assessment workshop demonstrates that despite the different approaches taken to perform the clinical assays, fetal RHD genotyping is a reliable laboratory assay to guide targeted use of Rh prophylaxis in a clinical setting.

Original languageEnglish
JournalVox Sanguinis
Volume114
Issue number4
Pages (from-to)386-393
Number of pages8
ISSN0042-9007
DOIs
Publication statusPublished - May 2019

    Research areas

  • Education, Continuing, Exons, Female, Fetal Diseases/genetics, Fetus, Genotype, Humans, Pregnancy, Prenatal Diagnosis/methods, Quality Assurance, Health Care, Quality Control, Quality of Health Care, Real-Time Polymerase Chain Reaction, Reproducibility of Results, Rh Isoimmunization/genetics, Rh-Hr Blood-Group System/blood, Rho(D) Immune Globulin/blood

ID: 57849787