The iSAFE™ Non-Invasive Prenatal Test (NIPT) Assay applies Crystal Digital PCR™ technology on the 6-color naica® system to accurately quantify the copy numbers of chromosome 21, 18, and 13 in maternal blood cell-free DNA (cfDNA). The iSAFE™ NIPT Assay screens for aneuploidy of chromosomes 21 (Down Syndrome), 18 (Edwards Syndrome), and 13 (Patau Syndrome) in singleton pregnancies and allows for fetal fraction calculation and gender determination.
The iSAFE™ NIPT Assay includes optimized reagents to be used in combination with the naica® multiplex PCR MIX to screen for multiple targets in a high-plex and simple workflow on the naica® system.
(The iSAFE™ NIPT Assay does not include the naica® multiplex PCR MIX, which is sold separately.)
The iSAFE™ NIPT Assay is only available in selected regions. The exclusion of commercial NIPT services applies only in the United States and the European Union.