RhD incompatibility remains a critical concern in prenatal care, with the potential to cause hemolytic disease of the fetus and newborn (HDFN) — a preventable but potentially life-threatening condition. In our recent Devyser launch webinar, Product Manager Claudia Durall introduced the newly IVDR-certified Devyser RHD kit — a safe and straightforward solution for non-invasive fetal RhD screening.
Mothers deserve modern medicine: Devyser RHD allows for targeted treatment
Alloimmunization against the D antigen occurs when an RhD-negative mother is exposed to RhD-positive fetal blood, triggering an immune response that can harm current or future pregnancies. While routine anti-D prophylaxis has dramatically improved outcomes, it is still widely administered to all RhD-negative mothers, despite nearly 40% of them carrying RhD-negative fetuses — resulting in unnecessary use of blood-derived products.
"Targeting anti-D prophylaxis to those who benefit from it, must be preferred compared to offering it to all RhD negative women"1
A reliable, non-invasive prenatal test (NIPT) is essential for targeted treatment. Devyser RHD meets this need with a fast, accurate, and streamlined solution based on cell-free fetal DNA (cffDNA) analysis from maternal plasma. This allows testing as early as week 10 of gestation.
Why Devyser RHD stands out
The assay features a single-exon design, targeting exon 4 of the RHD gene, simplifying interpretation and reducing the level of inconclusive results from contradictory data that multi-exon testing might present. This approach ensures:
With just one PCR mix run in triplicate per sample, Devyser RHD reduces operational complexity, making it ideal for small labs and large-scale screening programs alike.
“In Sweden today, all regions except two in northern Sweden are screening, and all but two using single-exon design.”2,3
Regulatory milestones and clinical impact
Recently awarded IVDR Class D certification — the highest risk class under European regulations — Devyser RHD also holds regulatory approval in Canada (Class III) and Australia (Class IV). Its performance is backed by a high sensitivity, specificity, and reproducibility in several large studies from clinical settings.4,5,6
In Sweden, Devyser RHD is already routinely used across most of the country. The test’s reliability has led to the discontinuation of confirmatory newborn serology in the major regions, reflecting trusted clinical use. Devyser RHD has been adopted in national screening programs in other countries, such as Wales. Over 100,000 RhD-negative pregnancies have been tested to date.
Watch the webinar on-demand
To explore the full potential of this innovative assay, including a deep dive into the workflow and clinical data, watch the on-demand webinar hosted by Claudia Durall. It’s an excellent opportunity for lab professionals, OB/GYNs, and healthcare decision-makers to understand how Devyser RHD can transform RhD screening in their practice.
Disclaimer: Devyser products are distributed worldwide. Not all intended uses and applications mentioned here are available in every country. Please consult your local sales representative for details.
References:
1. Expert review: Fetal RHD screening in clinical routine. Prof. Agneta Wikman. Devyser, 2024.
2. Taune Wikman A, Tiblad E, Karlsson A, Olsson ML, Westgren M. Non invasive single exon determination of fetal RHD in a routine screening programme in early pregnancy. Obstetr Gyneol 2012; 120:227-234
3. Tiblad E, Taune Wikman A, Ajne G, Blanck A Targeted routine antenatal anti-D prophylaxis in the prevention of RhD immunization-outcome of a new antenatal screening and prevention program PloS One 2013, Aug 6
4. Isakson, P., & Pardi, C. (2023). evaluation of an automated platform for non-invasive single-exon fetal RHD genotyping early in pregnancy. Blood Transfus, 21, 472–478. https://doi.org/10.2450/2023.0267-22
5.Pardi, C., Hellberg, Å., & Isakson, P. (2024). Single-exon fetal RHD genotyping: a 31-month follow up in the obstetric population of Western Sweden. Blood Transfus. https://doi.org/10.2450/BloodTransfus.741
6. Uzunel, M., Tiblad, E., Mörtberg, A., & Wikman, A. (2022). Single-exon approach to non-invasive fetal RHD screening in early pregnancy: An update after 10 years’ experience. Vox Sanguinis, 117(11), 1296–1301. https://doi.org/10.1111/VOX.13348