POSPÍŠILOVÁ, Šárka and Kateřina STAŇO KOZUBÍK. External performance evaluation study report: Clarigo. Brno: Multiplicom N.V., 2015. 3 pp.
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Basic information
Original name External performance evaluation study report: Clarigo
Authors POSPÍŠILOVÁ, Šárka (203 Czech Republic, belonging to the institution) and Kateřina STAŇO KOZUBÍK (203 Czech Republic, guarantor, belonging to the institution).
Edition Brno, 3 pp. 2015.
Publisher Multiplicom N.V.
Other information
Original language English
Type of outcome Research report
Field of Study Genetics and molecular biology
Country of publisher Czech Republic
Confidentiality degree contents are subject to a state secret
RIV identification code RIV/00216224:14740/15:00087326
Organization unit Central European Institute of Technology
Keywords in English NIPT; NGS; Down syndrome; aneuploidies
Tags rivok
Changed by Changed by: Mgr. Eva Špillingová, učo 110713. Changed: 21. 4. 2016 09:00.
Abstract
*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.*
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