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

• Conditions: O26; Maternal care for other conditions predominantly related to pregnancy

• Registration Number: DRKS00025039
• Lead Sponsor: niversitätsmedizin Göttingen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-13
• Study Completion: 2022-08-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 198

Inclusion Criteria

at least 18 years old
-RhD negative according to the maternal documents
-pregnancy
-at least 11 weeks of gestation
-ability to give informed consent

Exclusion Criteria

-all persons who do not meet the inclusion criteria will be excluded. According to German guidelines multiple pregnancies are not eligible for targeted anti-D prophylaxis. However, multiple pregnancies are eligible for this study.

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Determination of the sensitivity of the FetoGnost RhD assay in comparison with the NIPT RhD reference with 95 % confidence intrval.<br>- Determination of the specificity of the FetoGnost RhD assay in comparision with the NIPT RhD reference with 95 % confidence interval.

Secondary Outcome Measures

Name	Time	Method
- Sensitivity of the FetoGnost RhD assay taking the newborn's serological RhD status as a reference. In case of discrepncy the molecular RhD status determined from the newborn's buccal swab is regarded a gold standard.<br>- Specificity of the FetoGnost RhD assay taking the newborn's serological RhD status as a reference. In case of discrepncy the molecular RhD status determined from the newborn's buccal swab is regarded a gold standard.<br>- Percentage of undetermined results.<br>- Diagnositic sensitivity and specificity of the FetoGnost RhD assay in multiple pregnancies in comparison with singleton pregnancies.<br>- Diagnosic sensitivity and specificity of the FetoGnost Kit RhD in the subgroups 11-19 weeks of gestation and >19 weeks of gestation.