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Diagnostic performance of the noninvasive prenatal FetoGnost RhD assay for the prediction of the fetal RhD blood group status
- Source :
- Archives of Gynecology and Obstetrics
- Publication Year :
- 2021
- Publisher :
- Springer Science and Business Media LLC, 2021.
-
Abstract
- 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 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 2968 pregnant women between weeks 5 + 6 and 40 + 0 of gestation (median 12 + 6) and conclusive results were obtained in 2888 (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.
- Subjects :
- Adult
Male
medicine.medical_specialty
Adolescent
NIPT-RhD
RhD positive
Diagnostic accuracy
030204 cardiovascular system & hematology
Real-Time Polymerase Chain Reaction
Maternal-Fetal Medicine
Serology
Young Adult
03 medical and health sciences
Fetus
0302 clinical medicine
Targeted anti-D prophylaxis
Clinical decision making
Pregnancy
Prenatal Diagnosis
Humans
Medicine
Retrospective Studies
Rh-Hr Blood-Group System
030219 obstetrics & reproductive medicine
business.industry
Obstetrics
Multiple pregnancies
Early gestation
Infant, Newborn
Obstetrics and Gynecology
Prenatal Care
General Medicine
Middle Aged
Blood Group Antigens
Gestation
Female
business
Subjects
Details
- ISSN :
- 14320711 and 09320067
- Volume :
- 304
- Database :
- OpenAIRE
- Journal :
- Archives of Gynecology and Obstetrics
- Accession number :
- edsair.doi.dedup.....9563b23c2048837e371059182e9c12b0