We are excited to announce that our FetoGnost® Kit RHD is now IVDR-certified!
Rhesus factor D (RhD) is the most common of the 5 main Rhesus antigens. The associated, dominantly inherited RHD gene constitutes a person as RhD-positive or -negative, most of the population being positive. In RhD-negative mothers carrying an RhD-positive fetus, sensitization can trigger a maternal immune response, producing IgG anti-D antibodies.
This leads to fetal hemolytic disease in subsequent pregnancies, critically endangering the developing fetus. An early, accurate diagnosis is needed for health care professionals to decide whether to initiate treatment with targeted anti-D prophylaxis when needed or avoid unnecessary treatment in RhD-negative pregnant women.
Our solution for fast, reliable, and non-invasive determination of the fetal RHD-status:
FetoGnost® Kit RHD (CE-IVDR)
A qualitative real-time PCR test detecting exons 5, 7, and 10 of the RHD gene in cell-free fetal DNA (cffDNA), suitable for women of all ages from the 12th week of pregnancy (gestational age ≥ 11+0).
Features:
• Highly specific and sensitive
• Multiplex PCR for detection of exons 5, 7 and 10 (VIC, FAM, NED)
• Identification of RHD variants possible
• Say goodbye to false negatives: Internal Positive Control (IPC) included (Cy5)
• Only a 2 ml maternal blood sample is needed
Non-invasive. Targeted. Trusted.