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External quality assessment of noninvasive fetal RHD genotyping

Clausen, Frederik Banch and Hellberg, Åsa LU (2020) In Vox Sanguinis 115(5). p.466-471
Abstract

Background and objectives: Fetal RHD genotyping of cell-free maternal plasma 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 31 laboratories. Materials and methods: Aliquots of pooled maternal plasma from gestational week 25 were sent to each laboratory. One sample was fetal RHD positive, and a second sample was fetal RHD negative. A reporting scheme was supplied for data collection, including questions regarding the methodological setup, results and clinical recommendations. The samples were tested blindly. Results:... (More)

Background and objectives: Fetal RHD genotyping of cell-free maternal plasma 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 31 laboratories. Materials and methods: Aliquots of pooled maternal plasma from gestational week 25 were sent to each laboratory. One sample was fetal RHD positive, and a second sample was fetal RHD negative. A reporting scheme was supplied for data collection, including questions regarding the methodological setup, results and clinical recommendations. The samples were tested blindly. Results: Different methodological approaches were used; 29 laboratories used qPCR and two laboratories used ddPCR, employing a total of eight different combinations of RHD exon targets. Fetal RHD genotyping was performed with no false-negative and no false-positive results. One inconclusive result was reported for the RHD positive 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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author
and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
cell-free fetal DNA, external quality assessment, fetal RHD genotyping, Rh prophylaxis
in
Vox Sanguinis
volume
115
issue
5
pages
6 pages
publisher
Wiley-Blackwell
external identifiers
  • scopus:85081750187
  • pmid:32166750
ISSN
0042-9007
DOI
10.1111/vox.12908
language
English
LU publication?
yes
id
49d56848-a6f2-4f30-b729-5d8b2d137775
date added to LUP
2020-04-14 16:32:15
date last changed
2024-06-12 12:53:34
@article{49d56848-a6f2-4f30-b729-5d8b2d137775,
  abstract     = {{<p>Background and objectives: Fetal RHD genotyping of cell-free maternal plasma 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 31 laboratories. Materials and methods: Aliquots of pooled maternal plasma from gestational week 25 were sent to each laboratory. One sample was fetal RHD positive, and a second sample was fetal RHD negative. A reporting scheme was supplied for data collection, including questions regarding the methodological setup, results and clinical recommendations. The samples were tested blindly. Results: Different methodological approaches were used; 29 laboratories used qPCR and two laboratories used ddPCR, employing a total of eight different combinations of RHD exon targets. Fetal RHD genotyping was performed with no false-negative and no false-positive results. One inconclusive result was reported for the RHD positive 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.</p>}},
  author       = {{Clausen, Frederik Banch and Hellberg, Åsa}},
  issn         = {{0042-9007}},
  keywords     = {{cell-free fetal DNA; external quality assessment; fetal RHD genotyping; Rh prophylaxis}},
  language     = {{eng}},
  number       = {{5}},
  pages        = {{466--471}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{Vox Sanguinis}},
  title        = {{External quality assessment of noninvasive fetal RHD genotyping}},
  url          = {{http://dx.doi.org/10.1111/vox.12908}},
  doi          = {{10.1111/vox.12908}},
  volume       = {{115}},
  year         = {{2020}},
}