This article presents the results of extensive preclinical testing of regent kits «Test-SRY» and «Test-RHD», TestGene for early non-invasive prenatal determining of fetal sex and Rh factor. Conducted an analysis of the data obtained in the course of a multicenter study of 11 remote laboratories results. The study involved 1,817 pregnant women. 1006 were analyzed for sex of the fetus and 811 – Rh of the fetus (all the women who participated in the analysis of rhesus fetus itself had a negative Rh factor). Established indicators: diagnostic accuracy, sensitivity, specifi city, positive predictive value, negative predictive value, as well as the proportion of false-positive and false-negative results.
Authors: Toropovsky AN, Nikitin AG, Zhmyrko EV Skorohodov LS, Belyakov AV Viktorov DA
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