Non-invasive fetal RHD genotyping


    RhD isoimmunization is the process of formation of antibodies in pregnant woman against antigens expressed on the surface of fetal erythrocytes. These antigens are not present on the surfacce of maternal's erythrocytes. These maternally-derived antibodies can cross the placenta and enter into the fetal blood circulation thus causing hemolysis of fetal erythrocytes and leading to developmet of fetal anemia and hemolytic disease of the newborn.

    The maternal organism produces specific anti-D antibodies after a process of sensibilization which occurs when fetal red blood cells enter the mother's blood circulation. RhD isoimmunization can occur in RhD negative pregnant women carrying a RhD positive fetus.

    Immunoprophylaxis with anti-D immunoglobulin is used routinely as part of the international guidelines for management of RhD negative pregnant women in order to prevent development of fetal anemia and hemolytic disease of the newborn.

    According to recent studies, about 40% of RhD negative women are carrying RhD negative fetus and prophylaxis with anti-D immunoglobulin is unnecessary in those women. Anti-D immunoglobulin is a blood-derived product with a potential risk for transmission of blood-borne infections as well as causing allergic reactions.

    Targeted immunoprophylaxis with anti-D immunoglobulin is part of current recommendations and guidelines for management of RhD negative pregnancies. Targeted immunoprophylaxis is made possible by the knowledge of fetal RhD status which can be determined by non-invasive prenatal genotyping.

    Free DNA Fetal Kit RhD® CE-IVD is a Real-Time PCR kit for non-invasive fetal RhD genotyping using a maternal blood sample.

    - Detection of 3 exons in the RhD gene: exon 5, 7 and 10

    - Early screening: the analysis can be performed starting from 11 gestational week

    - The analysis is based on Real-Time PCR methodology

    - The first CE-IVD certified kit for non-invasive fetal RhD genotyping

    - Very good correlation with the RhD genotype determined after birth – Positive Predictive Value – 99,18% and Negative Predictive Value – 100%

    - Allows discrimination between the most prevalent RhD variants

    - Approved in France, the United Kingdon, Belgium and other European countries where there is an integrated reimbursement program approved by the national health authorities.

    Advantages of Free DNA Fetal Kit RhD® CE-IVD for non-invasive fetal RhD genotyping:

    • Targeted immunoprophylaxis - administration of anti-D IgG only in RhD negative women with confirmed RhD positive fetus
    • In patients with RhD sensibilisation and confirmed RhD positive fetus allows for identification of high-risk pregnancies and the need for their careful follow-up
    • Patients with RhD sensibilisation and confirmed RhD negative fetus do not need frequent follow-up and they can have a smooth pregnancy
    • Reduces the unnecessary use of anti-D immunoglobulin and its associated health risks and side effects

    Files for download:
    Download Free DNA Fetal KitR RhD - Неинвазивно определяне на RHD статус на плода
    Download Free DNA Fetal Kit® RhD - Non-invasive fetal RhD genotyping (English)