Purpose: To evaluate the diagnostic accuracy of a commercially available test kit for noninvasive prenatal determination of the fetal RhD status (NIPT-RhD) with a focus on early gestation and multiple pregnancies.
Methods: The FetoGnost RhD assay (Ingenetix, Vienna, Austria) is routinely applied for clinical decision making either in woman with anti-D alloimmunization or in order to target the application of routine antenatal anti-D prophylaxis (RAADP) to women with a RhD positive fetus. Based on existing data in the laboratory information system the newborn’s serological RhD status was compared with NIPT RhD results.
Results: Since 2009 NIPT RhD was performed in 2,968 pregnant women between week 5+6 and 40+0 of gestation (median 12+6) and conclusive results were obtained in 2,888 (97.30%) cases. Diagnostic accuracy was calculated from those 2244 (77.70%) cases with the newborn’s serological RhD status reported. The sensitivity of the FetoGnost RhD assay was 99.93% (95% CI 99.61% - 99.99%) and the specificity was 99.61% (95% CI 98.86% - 99.87%). No false positive or false negative NIPT RhD result was observed in 203 multiple pregnancies.
Conclusion: NIPT RhD results are reliable when obtained with FetoGnost RhD assay. Targeted routine anti-D-prophylaxis can start as early as 11+0 weeks of gestation in singleton and multiple pregnancies.
Figure 1
Loading...
Posted 22 Mar, 2021
On 22 Feb, 2021
On 04 Feb, 2021
On 02 Feb, 2021
Posted 22 Mar, 2021
On 22 Feb, 2021
On 04 Feb, 2021
On 02 Feb, 2021
Purpose: To evaluate the diagnostic accuracy of a commercially available test kit for noninvasive prenatal determination of the fetal RhD status (NIPT-RhD) with a focus on early gestation and multiple pregnancies.
Methods: The FetoGnost RhD assay (Ingenetix, Vienna, Austria) is routinely applied for clinical decision making either in woman with anti-D alloimmunization or in order to target the application of routine antenatal anti-D prophylaxis (RAADP) to women with a RhD positive fetus. Based on existing data in the laboratory information system the newborn’s serological RhD status was compared with NIPT RhD results.
Results: Since 2009 NIPT RhD was performed in 2,968 pregnant women between week 5+6 and 40+0 of gestation (median 12+6) and conclusive results were obtained in 2,888 (97.30%) cases. Diagnostic accuracy was calculated from those 2244 (77.70%) cases with the newborn’s serological RhD status reported. The sensitivity of the FetoGnost RhD assay was 99.93% (95% CI 99.61% - 99.99%) and the specificity was 99.61% (95% CI 98.86% - 99.87%). No false positive or false negative NIPT RhD result was observed in 203 multiple pregnancies.
Conclusion: NIPT RhD results are reliable when obtained with FetoGnost RhD assay. Targeted routine anti-D-prophylaxis can start as early as 11+0 weeks of gestation in singleton and multiple pregnancies.
Figure 1
Loading...