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

Clausen, Frederik Banch and Barrett, Angela Natalie (2019) In Vox Sanguinis 114(4). p.386-393
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... (More)
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. © 2019 International Society of Blood Transfusion (Less)
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contributor
LU and LU
author collaboration
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
cell-free fetal DNA, external quality assessment, fetal RHD genotyping, Rh prophylaxis, article, controlled study, exon, false positive result, female, fetus, genotype, human, human tissue, maternal plasma, prophylaxis, quality control, quantitative analysis, real time polymerase chain reaction, room temperature
in
Vox Sanguinis
volume
114
issue
4
pages
386 - 393
publisher
Federation of European Neuroscience Societies and Blackwell Publishing Ltd
external identifiers
  • scopus:85062510754
  • pmid:30834546
ISSN
1423-0410
DOI
10.1111/vox.12768
language
English
LU publication?
yes
id
6d239467-1634-47da-91cf-a767c8e6d969
date added to LUP
2019-06-14 09:15:12
date last changed
2020-01-13 02:01:08
@article{6d239467-1634-47da-91cf-a767c8e6d969,
  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. © 2019 International Society of Blood Transfusion},
  author       = {Clausen, Frederik Banch and Barrett, Angela Natalie},
  issn         = {1423-0410},
  language     = {eng},
  number       = {4},
  pages        = {386--393},
  publisher    = {Federation of European Neuroscience Societies and Blackwell Publishing Ltd},
  series       = {Vox Sanguinis},
  title        = {Noninvasive fetal RHD genotyping to guide targeted anti-D prophylaxis–an external quality assessment workshop},
  url          = {http://dx.doi.org/10.1111/vox.12768},
  doi          = {10.1111/vox.12768},
  volume       = {114},
  year         = {2019},
}