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Utility of fetal RhD screening

This large observational cohort trial from the Netherlands examined the accuracy with identifying RhD-positive fetuses using fetal RHD genotype screening on cell-free DNA isolates in maternal plasma in more than 32,000 RhDnegative women. Fetal RHD testing was conducted in week 27 of gestation and results were compared with cord blood analysis at birth. If the fetal RHD genotype test was positive, providers administered 200 μg anti-D immunoglobulin in the 30th week of gestation and within 48 hours after birth. If the fetal RHD genotype was negative, providers were told immunoglobulin was unnecessary. RHD-positive results occurred 62% of the time and RHD-negative results occurred 38% of the time. Cord blood samples were available for 25,789 pregnancies (80%). Overall, there were 225 false-positive and 9 false-negative results. The sensitivity for identifying the fetal RHD genotype was 99% and specificity was 98%, with a negative predictive value of 99% and a positive predictive value of 99%. In the 9 false-negative results, 6 were due to no fetal DNA in the sample and were found on repeat testing, and 3 were due to technical error. In 22 of the 225 false-positive results, followup serology or molecular testing found an RHD gene was present, meaning the result of routine cord blood serology in these cases were falsely negative.