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Non-invasive prenatal testing (NIPT): Europe’s first multicenter post-market clinical follow-up study validating the quality in clinical routine

Archives of Gynecology and Obstetrics Sep 19, 2017

Flock A, et al. - This study is performed to assess the accuracy of an NIPT for the determination of trisomies 21, 18 and 13 in singleton pregnancies by using the methods of a prospective German-wide multicenter post-market clinical follow-up study. The purpose of this study is to reliably assess the quality in clinical routine. Based on these outcomes, NIPT provides a very high quality for the fetal trisomies 21, 13 and 18 in clinical routine. The outcomes support the suggestion that NIPT ought to be offered after genetic counseling and only in conjunction with a qualified ultrasound examination.
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