Performed upon request made by a pregnant patient, BabyGen is a non-invasive prenatal genetic test designed to detect the sex of a foetus based on an analysis of free-circulating fetal DNA present in the maternal blood stream.
Method of analysis
The qualitative/quantitative PCR method involves detecting Y chromosome sequences of circulating DNA isolated from maternal blood plasma.
Biological and technological limits of the BabyGen test
The biological factors leading to false gender test results include:
- a very low quantity of free-circulating fetal DNA in maternal blood;
- multiple pregnancy;
- vanishing twin syndrome (incidence > 1 : 500 between Week 7 and Week 10 of pregnancy);
- XX/XY chimerism (placental or whole-body);
- presence of foreign DNA in maternal blood (following a blood transfusion, stem cell transplantation, organ transplantation, due to malignant diseases of the pregnant woman or her foetus).
The technological limits of the BabyGen test that may lead to false gender test results include:
- the detection limit of the methods used;
- blood sample contamination during blood sample collection or handling (blood samples must be collected and handled exclusively by female staff);
- failure to comply with the pre-analytical conditions of storing and transporting biological samples.