Methylation-specific quantitative PCR assay (qNIPT)
Determination of fetal trisomy 21 in singleton pregnancies
The novel qNIPT determines the differences in methylation patterns of specific gene regions of the maternal and fetal DNA. Certain gene regions in maternal DNA are hypo-methylated whereas the same gene regions are hyper-methylated in fetal DNA. These methylation specific gene regions are used as DNA biomarkers for the determination of fetal trisomy 21.
Methylation specific qPCR on reference and target
Relative quantification
A bioinformatic algorithm, integrated into the IVD software PraenaTest® DAP.plus, was developed to analyze the qPCR data. The algorithm has has been manufactured in accordance with the technical documentation set out in Annex IV to Directive 98/79/EC and it complies with the relevant requirements of the German Medical Devices Directive and Directive 98/79/EC of October 27, 1998, on in vitro diagnostic medical devices and corresponding harmonized standards.
Learn more about the method and the validation studies.