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Free DNA Fetal Kit RhD – Duplex

Reliable and non-invasive fetal RHD genotyping

An essential solution for optimising the care of RhD-negative pregnant women (RH:-1)

An innovative test for streamlined and targeted prenatal monitoring

The Free DNA Fetal Kit RhD – Duplex is a fetal RHD genotyping test performed using a simple maternal blood sample. It allows the RhD status of the fetus to be determined as early as the 11th week of amenorrhea, using a non-invasive method.

Essential for managing RhD feto-maternal incompatibility, this test reduces the administration of anti-D immunoglobulins and optimises the care of RhD-negative patients (RH: -1).

What are the key advantages of the Free DNA Fetal Kit RhD – Duplex ?

Maximum precision

100% sensitivity, amplification of exons 5, 7 and 10 of the RHD gene.

Cost savings

This test makes it possible to reduce the administration of anti-D immunoglobulins and optimise the management of RhD-negative patients (RH: -1).

Non-invasive method

A simple maternal blood test is all that is needed.

Compliant with European regulations

CE-IVD certified in accordance with Regulation (EU)2017/746.

Ease of integration

Compatible with standard laboratory automation systems and protocols.

Applications
and compatibility

The Free DNA Fetal Kit RhD – Duplex can be easily integrated into prenatal diagnostics laboratories, allowing test series ranging from 13 to 93 patients.

Integrate it into my laboratory

Box contents

Versions available :

Free DNA Fetal Kit RhD - Duplex

Reference : 502080533

Included in each kit :

  • Reagents for amplification of exons 5, 7 and 10 of the RHD gene.
  • Integrated controls :
    • RHD positive control (+)
    • RHD negative control (-)
    • Internal Control (IC)

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Why choose the Free DNA Fetal Kit RhD – Duplex?

A reliable, non-invasive and proven method for prenatal diagnosis

Maximum sensitivity and specificity, including management of genetic variants in the RH system.

A solution that can be easily integrated into laboratory workflows.

Full compliance with current regulations

  • In Europe – CE-IVD certification under Regulation (EU) 2017/746 for Class D devices.
  • In Australia – Assessment under the Therapeutic Goods (Medical Devices) Regulations 2002 (TG(MD)R 2002) and registration with the Therapeutic Goods Administration (TGA).
  • In Switzerland – Registration with SwissMedic in collaboration with a Swiss representative (CH-REP)
  • In the United Kingdom – Registration with the Medicines and Healthcare products Regulatory Agency (MHRA) in collaboration with a UK representative (UK-REP)

Need advice or a tailor-made solution?

Our team of experts is available to discuss your projects and answer your questions.

Contacts
  • Pôle Technologique Henri Farman
    4 Allée Albert Caquot
    51100 Reims, FRANCE
  • contact@ibjb.fr
  • phone : +33 (0)3 26 79 72 72
  • fax : +33 (0)3 26 79 72 73