Free DNA Fetal Kit RhD®
Kit for genotyping the fetal RHD gene from maternal blood, enabling 96 tests to be performed with 100% sensitivity, thanks to amplification of exon 5, 7 and 10.
Prescribed by gynecologists and midwives, carried out by accredited laboratories and reimbursed by governments as part of a public health policy, or by private insurers.
This flagship product has been a gold standard in Europe for 16 years.
Based on free circulating fetal DNA ("cff DNA") present in maternal blood as early as 7 weeks' gestation, our kit enables early diagnosis (11 weeks' gestation) of fetal rhesus in Rh-positive pregnancies.
Already adopted by a number of European countries, this test, performed on a simple sample of maternal blood, avoids unnecessary injections of anti-D immunoglobulins and eases the monitoring of RhD- pregnancies.
Because 40% of RhD- women have no incompatibility, we need to be able to screen them to move from costly systematic prophylaxis to targeted prophylaxis.
- CE IVD marked:
IBJB's fetal RHD genotyping kit meets European regulatory requirements by being certified as Class D under the new CE IVDR 2017/746 regulation, complies with Australia/Canada MDSAP requirements and is registered with TGA Australia.
- Automated:
DNA extraction from blood plasma, and amplification of exons 5,7 & 10 of the RHD gene are validated on the most commonly used automats.
- Reimbursed or recommended for reimbursement:
Some countries already reimburse the test, while learned societies in other countries recommend its use and reimbursement as a prenatal test when maximum sensitivity is proven.