iSAFE™ NIPT System – For Detection of T21, T18, T13 & SCA with the QIAcuity™ System (CE-IVD)
The iSAFE Non-Invasive Prenatal Test (NIPT) System is intended to detect designated targets of Chr21, Chr18, Chr13, and ChrX in the human genome for diagnosing Trisomy 21, Trisomy 18, Trisomy 21, SCA, fetal fraction quantification, and gender determination.
The iSAFE NIPT System includes the iSAFE NIPT Kit (REF: NIPT-100QS) and the iSAFE NIPT Data Analysis Software (REF: NIPT-ST)
*Each kit includes 100 tests.
For In-Vitro Diagnostic Use
iSAFE™ NIPT System – For Detection of T21, T18, T13 & SCA with the QIAcuity™ System (CE-IVD)
The iSAFE™ NIPT System – For Detection of T21, T18, T13 & SCA with the QIAcuity™ System (CE-IVD) is for in-vitro diagnostic use and tests for aneuploidy of chromosomes 21 (Down Syndrome), 18 (Edwards Syndrome), 13 (Patau Syndrome), and SCA in singleton pregnancies.
The kit applies the digital PCR platform to accurately quantify the copy numbers of chromosome 21, 18, 13, and X in maternal blood cell-free DNA (cfDNA).
The iSAFE NIPT Data Analysis Software
The iSAFETM NIPT Data Analysis Software (Ref: NIPT-ST) is intended to be
used in conjunction with the iSAFETM NIPT Test Kit (NIPT-100QS) for
the detection of designated targets of Chr21, Chr18, Chr13, and ChrX in the
human genome.
Features Include
Technical Specs
Workflow Overview for the iSAFE™ NIPT System – For Detection of T21, T18, T13 & SCA with the QIAcuity™ System (CE-IVD)
This section is for demonstrative purposes only and may be incomplete or inaccurate. Always refer to the product instructions for precise guidelines and directions.
Collect maternal blood sample.
dPCR reaction assembly.
Digital PCR.
