Diagnostic performance of the noninvasive prenatal FetoGnost RhD assay for the prediction of the fetal RhD blood group status.
Arch Gynecol Obstet
; 304(5): 1191-1196, 2021 11.
Article
em En
| MEDLINE
| ID: mdl-33835210
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.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Sistema do Grupo Sanguíneo Rh-Hr
/
Antígenos de Grupos Sanguíneos
/
Feto
Tipo de estudo:
Diagnostic_studies
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Adolescent
/
Adult
/
Female
/
Humans
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Male
/
Middle aged
/
Newborn
/
Pregnancy
Idioma:
En
Revista:
Arch Gynecol Obstet
Assunto da revista:
GINECOLOGIA
/
OBSTETRICIA
Ano de publicação:
2021
Tipo de documento:
Article
País de afiliação:
Alemanha