Genotyping Test Kit

Free DNA Fetal Kit RhD®Thanks to the amplification of exons 5, 7, and 10, this genotyping kit for the fetal RHD gene from maternal blood allows for the execution of 96 tests with 100% sensitivity.

Gynecologists and midwives prescribe these procedures, which are conducted by accredited laboratories and reimbursed by governments as part of a public health policy or by private insurers.

For sixteen years, this flagship product has been the gold standard in Europe.

Our kit enables the early diagnosis of fetal rhesus in Rh-positive pregnancies at 11 weeks’ gestation, based on free circulating fetal DNA (“cff DNA”) present in maternal blood as early as 7 weeks’ gestation.

This test, which is already implemented in numerous European countries, is conducted on a straightforward maternal blood sample. It simplifies the monitoring of RhD-pregnancies and prevents the need for unnecessary anti-D immunoglobulin injections.

Given that 40% of RhD- women lack incompatibility, it is imperative that we be able to screen them in order to transition from costly systematic prophylaxis to targeted prophylaxis.input:
output:- CE IVD marked:IBJB’s fetal RHD genotyping kit is registered with TGA Australia, complies with Australia/Canada MDSAP requirements, and is certified as Class D under the new CE IVDR 2017/746 regulation, meeting European regulatory requirements.

– Automated:Validation of the most frequently employed automats is conducted for DNA extraction from blood plasma and amplification of exons 5, 7, and 10 of the RHD gene.

– Reimbursed or recommended for reimbursement:The test is already reimbursed in certain countries, and learned societies in other countries recommend its use and reimbursement as a prenatal test once maximum sensitivity is demonstrated.