![]() ![]() Gestational Age of the 135 Pregnant ParticipantsĬlinical Performance of SneakPeek Early Gender Test This blinded study showed that SneakPeek Early Gender Test is highly accurate for fetal sex determination in early pregnancy. SneakPeek accuracy, sensitivity and specificity were each 100% for fetal sex identification. Fetal sex for all samples was unknown prior to genetic testing and was confirmed via sonographic evaluation at the conclusion of the study. Assay precision data showed minimal variation and high reproducibility of results. SneakPeek correctly identified fetal sex in all samples. Y-chromosome DNA was detected in all samples from women carrying a male fetus. Sixty maternal plasma samples were tested twice, on different days, to assess the precision of SneakPeek.Ĭell-free DNA was detected in all maternal blood samples. ![]() An autosomal control gene was used to measure total cell-free DNA (maternal and fetal cfDNA). Circulating cell-free DNA was isolated from a micro-volume of maternal plasma and real-time quantitative PCR was performed to detect fetal DNA using a multi-copy sequence on the Y chromosome. A multicenter-blinded study was conducted at four ultrasound clinics with maternal blood samples collected from pregnant women between 9 and 35 weeks of gestation. The purpose of this study was to assess the clinical performance of SneakPeek® Early Gender Test (Gateway Genomics) for noninvasive prenatal testing (NIPT) of fetal sex. Multicenter blinded study conducted at four ultrasound clinics in 2015 ![]()
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