Noninvasive fetal RHD genotyping to guide targeted anti-D prophylaxis–an external quality assessment workshop
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- vox.12768
Accepted author manuscript, 275 KB, PDF document
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 language | English |
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Journal | Vox Sanguinis |
Volume | 114 |
Issue number | 4 |
Pages (from-to) | 386-393 |
Number of pages | 8 |
ISSN | 0042-9007 |
DOIs | |
Publication status | Published - 2019 |
- cell-free fetal DNA, external quality assessment, fetal RHD genotyping, Rh prophylaxis
Research areas
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