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The sex of the fetus is determined by the presence of Y-specific sequences with intra-assay concordance for a male fetus and the absence of Y specific DNA sequences for a female.
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Description: The Fetal Sex Determination Kit targets specific sequences on Chromosome Y: SRY, TSPY and DAZ for use in cases of a suspected X-linked condition. Also included is a control gene (CCR5) to confirm there is an adequate amount of cell free DNA within the sample. The sex of the fetus is determined by the presence of Y-specific sequences with intra-assay concordance for a male fetus and the absence of Y specific DNA sequences in the case of a female fetus. Technical Performance: Technical sensitivity of our assay was demonstrated using male gDNA spiked into a female gDNA background at fixed percentages (10%, 5% and 1% or 30, 15 and 3 genomic equivalents) to reproduce realistic fetal fractions and confirm the sensitivity of the assay. Amplification of all targets across all replicates was observed even at the lowest 1% spike-in.