External quality assessment of noninvasive fetal RHD genotyping.

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: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.

journal_name

Vox Sang

journal_title

Vox sanguinis

authors

Clausen FB,Hellberg Å

doi

10.1111/vox.12908

subject

Has Abstract

pub_date

2020-07-01 00:00:00

pages

466-471

issue

5

eissn

0042-9007

issn

1423-0410

journal_volume

115

pub_type

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