Evidence map›Paper›PMID 33835210›Full record

ArticleArchives of gynecology and obstetrics2021

Diagnostic performance of the noninvasive prenatal FetoGnost RhD assay for the prediction of the fetal RhD blood group status.

Tobias J Legler, Sandra Lührig, Irina Korschineck, Dieter Schwartz

Abstract read
In one paragraph

Article in Archives of gynecology and obstetrics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
  2. Noninvasive fetal blood group antigen genotyping.Blood transfusion = Trasfusione del sangue · 2025
    Review
  3. Review
  4. FetalBiomedicines · 2023
    Article
  5. Non-invasive prenatal diagnosis (NIPD): current and emerging technologies.Extracellular vesicles and circulating nucleic acids · 2023
    Review
  6. Article
  7. Review
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Tobias J LeglerDepartment of Transfusion Medicine, University Medical Center Göttingen, Robert-Koch-Str. 40, 37075, Göttingen, Germany. tlegler@med.uni-goettingen.de.ORCID 0000-0002-1408-5397
Sandra LührigDepartment of Transfusion Medicine, University Medical Center Göttingen, Robert-Koch-Str. 40, 37075, Göttingen, Germany.
Irina KorschineckIngenetix GmbH, Vienna, Austria.
Dieter SchwartzDepartment of Blood Group Serology and Transfusion Medicine, Medical University of Vienna, Vienna, Austria.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo 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.

methodsThe 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.

resultsSince 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.

conclusionNIPT 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.

Indexed as

Blood Group AntigensAdolescentAdultFemaleFetusHumansInfant, NewbornMaleMiddle AgedPregnancyPrenatal CarePrenatal DiagnosisReal-Time Polymerase Chain ReactionRetrospective StudiesRh-Hr Blood-Group SystemYoung AdultBlood Group AntigensRh-Hr Blood-Group SystemDiagnostic accuracyMultiple pregnanciesNIPT-RhDTargeted anti-D prophylaxis

Identifiers

PMID33835210
PMCPMC8490250

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