Description

TarCET PGT kit is an NGS-based, CE-marked under IVDD, that includes reagents for a universal library preparation and target capture enrichment workflow to detect whole chromosome aneuploidies, structural rearrangements, and segmental aneuploidies down to 10Mb, selected male polyploidies, and mosaicism higher than 50%.

Intended use

This TarCET PGT Kit is a CE marked, Next Generation Sequencing (NGS) product intended to be used for identification of genetic variants associated with diseases. The TarCET PGT Kit (CE) assay is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained.

Genetic testing

TarCET PGT Kit provides the detection of selected male polyploidies (69,XXY; 69,XYY; 92,XXXY), whole chromosome aneuploidies and structural rearrangements down to 10 Mb in size, as well as mosaicism higher than 50%, in fertilized embryos at the blastomere (Day 3 or cleavage stage) or blastocyst stage (Day 5 stage).

Technical limitations

TarCET PGT Kit results only reflect the DNA of the biopsied cells, and in some cases, due to technical or biological reasons, testing may not identify an abnormality even though one exists. The accuracy of the test results is also dependent upon the quality of the embryo, the correct practice of the biopsy procedure, the chromosomal status of the cells tubed, the level of mosaicism, and the patient’s clinical diagnosis and karyotype in the case of structural rearrangements. The TarCET PGT Kit can detect selected male polyploidies (69,XXY; 69,XYY; 92,XXXY) but cannot detect haploids. The TarCET PGT Kit cannot differentiate between embryos that are chromosomally balanced for the structural rearrangement and euploid embryos. The TarCET PGT Kit can detect full chromosome aneuploidies and chromosomal rearrangements (partial deletions/duplications) larger than 10Mb, depending on which Illumina sequencing platform is used (refer to SIRIUS user guide). The TarCET PGT Kit cannot detect single gene disorders or Uniparental Disomy (UPD). The TarCET PGT Kit cannot ensure a successful pregnancy or a healthy baby, or completely eliminate the risk of miscarriage or birth of a baby with a chromosomal aneuploidy, physical or cognitive impairment.