Prenatal diagnosis

Free DNA Fetal RhD kit

Fetal genotyping kit rhd from maternal blood sample

Based on the detection of free circulating fetal DNA ("cff DNA") present from the 7th SA in maternal blood, our kit allows early diagnosis (11th SA) of the fetal RHD genotype in the context of an Rh- woman pregnancy. Performed on a simple maternal blood sample, this test avoids unnecessary and potentially risky injections of anti-D immunoglobulins and reduces the follow-up of RhD- female pregnancies.
It is prescribed by gynecologists and midwives and performed by accredited laboratories.

100% MADE IN FRANCE
an IBJB exclusivity
CE IVD marked
The Free DNA Fetal RhD Kit is the first labeled RHD fetal genotyping kit meeting European regulatory requirements and the Public Health Code (DMDIV label CE / IVD, list IIA).
Automated
Extraction of the DNA from the blood plasma, and amplification of exons 5,7 & 10 of the RHD gene are validated on the most commonly used automata.
Reimbursed in France
Recommended by the French CNGOF since 2006 and HAS since 2011(2), the fetal RHD genotyping test is registered with the French nomenclature and 100% funded by the French CNAM since July 2017(3).
 
 
 
 
 
1-In France, the laboratories using this kit must be authorised by their Regional Health Agency to perform molecular genetical tests in prenatal diagnosis and / or genetical tests on cell free fetal DNA circulating in maternal blood.
2-SYNTHÈSE DE RAPPORT D’ÉVALUATION DE TECHNOLOGIES DE SANTÉ - Le génotypage RHD prénatal à partir du sang maternel « Un progrès par rapport aux autres techniques de détermination du Rhésus fœtal » - HAS Janvier 2011.
3-Décision du 24 mai 2017 de l’Union Nationale des Caisses d’Assurance Maladie
100% MADE IN FRANCE
une exclusivité IBJB
marqué CE IVD
Le Free DNA Fetal RhD®Kit est le premier kit de génotypage RHD fœtal labellisé répondant aux exigences réglementaires européennes et au Code de la Santé Publique (DMDIV label CE/IVD).
Automatisé
L’extraction de l’ADN depuis le plasma sanguin, et l’amplification des exons 5,7 & 10 du gène RHD sont validées sur les automates les plus couramment utilisés.
Test remboursé
Recommandé par le CNGOF depuis 2006 et la HAS depuis 2011, le test de génotypage RHD fœtal est inscrit à la NABM et pris en charge à 100% par la CNAM depuis juillet 2017.
Composition of the kit
3 exons for a maximum sensitivity at 100%
The molecular biology kit (BM) proposed by our Institute includes all the necessary elements *.
It is exclusively dedicated to the determination of RHD fetal and does not allow any other diagnosis such as the sex of the fetus for example.
* 96 tests with the "duplex" kit / TAQ is not included in this kit
Every year
60000 MOTHERS-TO-BE
RECEIVE USELESS
ANTI-D PROPHYLAXIS
A test for whom?
In France
150000 pregnancies Rh-
per year

Prescribed routinely in France for Rh- mothers-to-be,
fetal RHD genotyping on maternal blood
will target prophylaxis in case of
real maternal fetal incompatibility Rhesus D
and focus use of Anti-D Immunoglobulins for Only
risky pregnancies (Rh+ fetus).

The benefits
Alleviate the
follow-up of women
with Rh+ fetuses

-Avoid systematic and unnecessary injections
-Simplify the management of women with Rh+ fetuses
-Reduce public health expenditure (if reimbursed)

Testimonies and recommandations

As a facilitator of your profession and a partner in your development,
we develop products that meet the constraints you must meet.

  • Practical recommandations of the French Syndicate of Gynecologists, 2005, update 12/17
    Paragraph 1 "General measures during pregnancy", extrait
    In french on the original text - A double determination of RhD blood group and an irregular agglutinin test (RAI) must be obtained in the first trimester of pregnancy in all women. If the woman is RhD negative [...] the spouse's RhD group is to be documented. If the spouse has a positive or unknown Rhesus D group, a fetal RhD genotyping on maternal blood is performed from 11 weeks of age […]. »

  • Service evaluation of the professional acts of the French HAS, short text 01/11
    Prenatal determination of fetal RHD genotype from maternal blood, "context" paragraph, extract
    In French in the original text - « For maternal pregnancies of the RH: -1 phenotype and of the RH: 1 phenotype father, the knowledge of the RHD genotype of the fetus would make it possible, in the already immunized mothers, to identify the pregnancies to be subject to specialized specialized follow-up if the fetus is RH: 1 because of the risk of fetal anemia [...]; in unimmunized mothers, to identify pregnancies for prophylaxis, if the fetus is RH: 1, by anti-D immunoglobulin, blood products whose availability is limited. »

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