This preprint is under consideration at Archives of Gynecology and Obstetrics. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research Article
Tobias J. Legler
Georg-August-Universitat Gottingen Universitatsmedizin
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1408-5397
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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.
Keywords
NIPT-RhD, diagnostic accuracy, targeted anti-D prophylaxis, multiple pregnancies
Figure 1
Loading...
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 22 Mar, 2021
No community comments so far
Editor assigned
On 22 Feb, 2021
Editor invited
On 04 Feb, 2021
First submitted
On 02 Feb, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Obstetrics & Gynecology
Learn more about our company.
This preprint is under consideration at Archives of Gynecology and Obstetrics. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research Article
Tobias J. Legler
Georg-August-Universitat Gottingen Universitatsmedizin
Corresponding Author
ORCiD: https://orcid.org/0000-0002-1408-5397
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 22 Mar, 2021
No community comments so far
Editor assigned
On 22 Feb, 2021
Editor invited
On 04 Feb, 2021
First submitted
On 02 Feb, 2021
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Obstetrics & Gynecology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
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...