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Noninvasive fetal RHD genotyping to guide targeted anti-D prophylaxis-an external quality assessment workshop.

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Authors
Clausen, Frederik Banch
Barrett, Angela Natalie
Akkok, Cigdem Akalin
Armstrong-Fisher, Sylvia
Bergstrom, Karolina Danielsson
Boggione, Carolina Trucco
Baevre, Mette Silihagen
Choolani, Mahesh
Christiansen, Mette
Cotorruelo, Carlos
Drnovsek, Tadeja Dovc
Finning, Kirstin
Guz, Katarzyna
de Haas, Masja
Haimila, Katri
Halldorsdottir, Anna Margret
Hellberg, Asa
Henny, Christine
Holmertz, Camilla
Al Houghton, Jayne
Hyland, Catherine
Jakobsen, Marianne Antonius
Kvitland, Mona Andersen
Lambert, Mark
Legler, Tobias J.
Liew, Yew-Wah
Muniz-Diaz, Eduardo
Mortberg, Anette
Niederhauser, Christoph
Nogues, Nuria
Nystrom, Sofia
Olsson, Martin L
Orzinska, Agnieszka
Parks, Michael
Rietkotter, Eva
Ryan, Helen
Sachs, Ulrich J
van der Schoot, Ellen
Silcock, Lee
Steffensen, Rudi
Sulin, Kati
Sorensen, Anne Solling
Tarrant, Sarah
Thorlacius, Steinunn
Wienzek-Lischka, Sandra
Wikman, Agneta
Wulf-Johansson, Helle
Zupan, Mojca
Dziegiel, Morten Hanefeld
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Issue Date
2019-05

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Citation
Noninvasive fetal RHD genotyping to guide targeted anti-D prophylaxis-an external quality assessment workshop. 2019, 114(4):386-393 Vox Sang
Abstract
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.
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https://onlinelibrary.wiley.com/doi/full/10.1111/vox.12768
ae974a485f413a2113503eed53cd6c53
10.1111/vox.12768
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English Journal Articles (Peer Reviewed)

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