To ensure the highest quality NIPT for your patients and practice, there are a number of critical quality standards to consider.

1. Can you rely on the performance claims of the NIPT?

Sonic Genetics uses NIPT reagents and equipment that are manufactured to the highest international standards. We do not modify the test processes unless directed to do so by the manufacturer. This ensures that we provide NIPT in consistent manner that matches “best practice” in the biggest and best laboratories around the world. The global scope of these testing methods has resulted in many published trials involving tens of thousands of women that document the performance of the assays that we use. 

2. Does your NIPT result come from the mother or the baby?

At 12 weeks gestation, approximately 90% of the DNA fragments found in maternal plasma come from the mother. This proportion varies widely across a population of pregnant women, and probably varies over time for the individual woman. The remaining DNA fragments come from placenta and represent the genetic status of the developing fetus as both placenta and fetus have developed from the same fertilised egg. 

For each sample of maternal plasma being analysed for NIPT, we check that there is sufficient fetal DNA in the maternal plasma to provide a reliable result. We will only report on the probability of there being a chromosome disorder in the fetus if there is sufficient fetal DNA to provide a reliable result.

Even though we confirm the presence of sufficient fetal DNA, there are occasional situations in which the placental DNA differs from that of the fetus. This places a biological limit on the accuracy of NIPT. For this reason, NIPT must be regarded as a screening test and not be used to make a definitive diagnosis.