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Non-innvasive prenatal diagnostics of fetal bloodgroup antigens (NIPDisk)

Sensitive and automated system for non-invasive prenatal diagnostics (NIPD) of the clinically most important blood group antigens form the 10th week of pregnancy. In addition to the Rhesus factor, it will - for the first time - allow for the determination of the antigens Kell and HPA-1a.

The most common immunological intolerance of a pregnant woman and the fetus is caused by the Rhesus factor (RhD). The pregnant woman develops specific alloantibodies which can cause morbus haemolyticus neonatorum (MHN) in the subsequent pregnancy. Non-invasive prenatal diagnostics (NIPD) allows for omission of the immunoprophylaxis in pregnant women with antigen-negative fetuses.

A feto-maternal incompatibility can also be triggered by other antigens (Kell, human platelet antigens - HPA). In this case, an immunization of the mother and damage to the fetus can already occur in the first pregnancy with an antigen-positive child. With early, prenatal diagnosis, immunoglobulin therapy can be applied to prevent diseases in the child.

The goal of the project is therefore to develop a sensitive, automated system for the NIPD of the clinically most important blood group antigens from the 10th week of pregnancy. For this purpose, cell-free DNA (cfDNA) from a whole blood sample of the mother is analyzed on a microfluidic cartridge (LabDisk) using digital droplet PCR (ddPCR).

Project
Non-invasive prenatal diagnostics of fetal blood group antigens
Sponsor
KMU-innovativ (BMBF)
Promoter
VDI Technologiezentrum GmbH
Funding Number
13GW0494
Duration
01.04.2021 to 31.03.2024
Cooperation Partner
inno-train Diagnostik GmbH, biotechrabbit GmbH, Institut für Transfusionsmedizin und Immunologie (ITI) an der Medizinischen Fakultät Mannheim der Universität Heidelberg
Maturity Level
Research
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Competences

  • Centrifugal microfluidics
  • Continuous monitoring
  • Molecular diagnostics
  • Food and water analysis
  • Alternatives to animal testing