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Single-exon approach to non-invasive fetal RHD screening in early pregnancy: An update after 10 years' experience. | LitMetric

AI Article Synopsis

  • - Anti-D prophylaxis helps prevent RhD immunization in RhD-negative women, and a non-invasive fetal RHD screening has been effectively used in Stockholm for over a decade to identify women who need this treatment.
  • - The study involved testing 4,337 pregnancies using a multiplex kit to analyze DNA from early pregnancy plasma, checking the results against newborn blood typing to assess the accuracy of the method.
  • - Results showed a high sensitivity of 99.93% and specificity of 99.56% for the screening method, demonstrating its reliability, although there were a few inconclusive and erroneous results primarily due to gene variants or technical issues.

Article Abstract

Background And Objectives: Anti-D prophylaxis, administered to RhD-negative women, has significantly reduced the incidence of RhD immunization. Non-invasive fetal RHD screening has been used in Stockholm for more than 10 years to identify women who will benefit from prophylaxis. The method is based on a single-exon approach and is used in early pregnancy. The aim of this study was to update the performance of the method.

Materials And Methods: The single exon assay from Devyser AB is a multiplex kit detecting both exon 4 of the RHD gene and the housekeeping gene GAPDH. Cell-free DNA was extracted from 1 ml of plasma from EDTA blood taken during early pregnancy, weeks 10-12. The genetic RHD results were compared with serological typing of newborns for a determination of sensitivity and specificity.

Results: In total, 4337 pregnancies were included in the study; 44 samples (1%) were inconclusive either due to maternal RHD gene variants (n = 34) or technical reasons (n = 10). Of the remaining 4293 pregnancies, a total number of nine discrepant results were found. False positive results (n = 7) were mainly (n = 4) due to RHD gene variants in the child. False-negative results were found in two cases, of which one was caused by a technical error. None of the false-negative cases was due to RHD gene variants. Overall, the sensitivity of the method was 99.93% and specificity 99.56%.

Conclusion: The single-exon assay used in this study is correlated with high sensitivity and specificity.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9826394PMC
http://dx.doi.org/10.1111/vox.13348DOI Listing

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