Evaluation of the FetoGnost RhD assay as non-invasive prenatal test for the determination of the fetal RhD Status (NIPT-RhD)

In the first part of the study 198 samples were registered in our laboratory. With the FetoGnost Kit RhD as well as with our in-house reference test 124 were tested positive for the fetal RhD and 66 negative, respecitvely. The sensitivity was 100 % (95 CI: 97 % - 100 %), the specificity was also 100 % (95 % CI: 94,5 % - 100 %). - Eight samples were excluded: In two cases, the material was only sufficient for testing with the reference assay; one sample was hemolytic, one sample was collected in week 7 of gestation, in 4 cases the mother was a carrier of the RHD gene, thus the fetal RhD status could not be assessed. - 190 study participants received a questionnaire about 3-4 after the calculated delivery date. A response was obtained in 104 cases, in 4 cases women moved to another unknown address and 82 did not respond. - When we compared the results from the the FetoGnost Kit RhD with the serological blood group result from the newborn, the results were 100 % concordant: 62 newborns were RhD-positive and 42 were RhD-negative.