Literature review - NIPT for fetal RHD status using an exon 4-based assay
Early non-invasive prenatal testing (NIPT) for fetal Rhesus D (RHD) status is playing an increasingly prominent role in antenatal care to ensure that anti-D prophylaxis is targeted to those women who will benefit from it. Devyser RHD is a CE-IVD test kit that uses cell free fetal DNA from maternal plasma to determine RhD blood group incompatibility as early as gestation week 10. With 99.9% diagnostic sensitivity and 99.9%specificity, our unique single-exon assay enables labs to increase throughput and shorten turnaround times. Devyser RHD builds on published methods for PCR based detection of exon 4 of the RHD gene, which encodes the Rh Blood Group D Antigen. Our kit improves on published sensitivity and specificity values for this test, and provides a simplified assay design that helps streamline and standardize the testing workflow.
We have summarized the findings of three seminal publications that support clinical implementation of our well-established single-exon detection strategy for fetal RHD screening in the first trimester of pregnancy to guide targeting of routine antenatal anti-D prophylaxis (RAADP).
What you'll learn
Learn why these studies are important and understand the key findings and conclusions:
• High sensitivity and specificity
• Good window of stability for routine clinical use
• High accuracy using exon 4 only, regardless of PCR strategy
• Very low false negative and low false positive rates
• Potential to reduce unnecessary anti-D treatment
Preview
Devyser RHD builds on published methods for PCR based detection of exon 4 of the RHD gene, which encodes the Rh Blood Group D Antigen. Our kit improves on published sensitivity and specificity values for this test, and provides a simplified assay design that helps streamline and standardize the testing workflow. Here we summarize the findings of three seminal publications that support clinical implementation of this well-established single-exon detection strategy for fetal RHD screening in the first trimester of pregnancy to guide targeting of routine antenatal anti-D prophylaxis (RAADP).
