Publication details
External performance evaluation study report: Clarigo
| Authors | |
|---|---|
| Year of publication | 2015 |
| MU Faculty or unit | |
| Attached files | |
| Description | *Based on request from Multiplicom company CEITEC MU research group Medical Genomics in collaboration with University Hospital Brno (Clinic of Obstetrics and Gynecology) collected and analyzed 300 samples of peripheral blood from pregnant women with known karyotype of their fetuses. These samples were analyzed with Clarigo kit using next generation sequencing (NGS) to validate this kit. Results were used together with results from other European laboratories to obtain CE IVD certificate for Clarigo test. Clarigo test (CE IVD) is non-invasive prenatal test (NIPT) for detection of most common chromosomal aneuploidies (Down, Edward, and Patau syndromes), and gender determination from 8th week of gestation. Clarigo test is currently well established and accredited according to CSN EN ISO 15189:2013 in Core facility Genomics – Center of Molecular Medicine CEITEC MU. The report is stored in Repository of MU.* |