4 Multiple studies have demonstrated the use of maternal plasma DNA for fetal sex determination. 3ĬffDNA represents about 10% of the total cell-free DNA in maternal plasma at 11–13 week’s gestation. 2Since its discovery, several studies have shown detectable amounts of cffDNA in maternal circulation as early as 5 weeks gestation, with testing becoming more reliable after 7 weeks gestation. The identification of fetal DNA in maternal blood paved the way for subsequent analysis of fetal DNA for non-invasive prenatal diagnosis. ![]() 1 The detection of cffDNA in maternal plasma and serum was first described by Dr. Keywords: sneak peek, NIPT, early gender test, pregnancy, fetal sex, maternal blood, maternal plasma, cell-free fetal DNA IntroductionĮarly sex determination has evolved from invasive techniques such chorionic villus sampling and amniocentesis to noninvasive prenatal testing through the analysis of cell-free fetal DNA (cffDNA). In this study, SneakPeek® accuracy, sensitivity, and specificity were 99.1%, 100%, and 98.2% for fetal sex identification, respectively.Ĭonclusion: This study showed that SneakPeek® Early Gender Test is highly accurate for fetal sex determination in pregnancy as early as 8 weeks gestation. Fetal sex for all samples were unknown prior to genetic testing and confirmed through a sonogram. A second sample was collected from the four participants and a result was obtained on the second round of testing. Four of the 108 samples initially yielded an inconclusive result. SneakPeek® correctly identified fetal sex in 107 of 108 pregnancies. Results: Male Y-chromosome DNA was detected in all samples from women carrying a male fetus. Total cell-free DNA (maternal and fetal circulating free DNA) was measured using an autosomal control gene. Real-time quantitative PCR was used to detect fetal DNA using a multi-copy sequence on the Y-chromosome. A commercial DNA extraction kit (MagMAX® Cell-Free DNA Isolation Kit) was used to isolate circulating cell-free DNA from maternal plasma. Plasma was separated from whole blood by centrifugation. Maternal blood samples were collected from 108 pregnant women between 7.00 and 10.57 weeks of gestation. Methods: A multicenter blinded study was conducted at five ultrasound clinics. ![]() The purpose of this study was to evaluate the clinical performance of SneakPeek® for noninvasive prenatal testing (NIPT) to determine fetal sex at an earlier time point: 8 weeks gestation. Background: Prior studies have shown that SneakPeek® Early Gender Test can accurately determine fetal sex as early as 9 weeks gestation using a qPCR-based assay.
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