TY - JOUR

T1 - Noninvasive fetal RHD genotyping to guide targeted anti-D prophylaxis–an external quality assessment workshop

AU - Clausen, Frederik Banch

AU - Barrett, Angela Natalie

AU - Akkök, Cigdem Akalin

AU - Armstrong-Fisher, Sylvia

AU - Bergström, Karolina Danielsson

AU - Boggione, Carolina Trucco

AU - Bævre, Mette Silihagen

AU - Choolani, Mahesh

AU - Christiansen, Mette

AU - Cotorruelo, Carlos

AU - Drnovsek, Tadeja Dovc

AU - Finning, Kirstin

AU - Guz, Katarzyna

AU - de Haas, Masja

AU - Haimila, Katri

AU - Halldorsdottir, Anna Margret

AU - Hellberg, Åsa

AU - Henny, Christine

AU - Holmertz, Camilla

AU - Houghton, Jayne A.L.

AU - Hyland, Catherine

AU - Jakobsen, Marianne Antonius

AU - Kvitland, Mona Andersen

AU - Lambert, Mark

AU - Legler, Tobias J.

AU - Liew, Yew Wah

AU - Muñiz-Diaz, Eduardo

AU - Mörtberg, Anette

AU - Niederhauser, Christoph

AU - Nogués, Núria

AU - Nyström, Sofia

AU - Olsson, Martin L.

AU - Orzinska, Agnieszka

AU - Parks, Michael

AU - Rietkötter, Eva

AU - Ryan, Helen

AU - Sachs, Ulrich J.

AU - van der Schoot, Ellen

AU - Silcock, Lee

AU - Steffensen, Rudi

AU - Sulin, Kati

AU - Sørensen, Anne Sølling

AU - Tarrant, Sarah

AU - Thorlacius, Steinunn

AU - Wienzek-Lischka, Sandra

AU - Wikman, Agneta

AU - Wulf-Johansson, Helle

AU - Zupan, Mojca

AU - Dziegiel, Morten Hanefeld

AU - The Noninvasive Fetal RHD Genotyping EQA2017 Working Group

PY - 2019

Y1 - 2019

N2 - 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.

AB - 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.

KW - cell-free fetal DNA

KW - external quality assessment

KW - fetal RHD genotyping

KW - Rh prophylaxis

U2 - 10.1111/vox.12768

DO - 10.1111/vox.12768

M3 - Journal article

C2 - 30834546

AN - SCOPUS:85062510754

VL - 114

SP - 386

EP - 393

JO - Vox Sanguinis

JF - Vox Sanguinis

SN - 0042-9007

IS - 4

ER -