Diagnostic accuracy of fetal rhesus D genotyping using cell-free fetal DNA during the first trimester of pregnancy

Vivanti, Alexandre J.; Benachi, Alexandra; Huchet, François-Xavier; Ville, Y.; Cohen, Henri; Costa, Jean‐Marc

doi:10.1016/j.ajog.2016.06.054

Cited by 23 publications

(22 citation statements)

References 25 publications

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“…In contrast, another study performed in 10-14 wg did not observe false-negative results in 416 serum samples (2.2% inconclusive). However, the specificity of an assay based on replicate testing of RHD exon 10 with 95.2% was lower than in the previous studies [32]. In our performance evaluation study, the sensitivity of 99.93% and specificity of 99.61% were as high as sensitivities and specificities determined in the second trimester with largescale screening studies [14,21,29,33].…”

Section: Discussioncontrasting

confidence: 55%

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

Legler

Lührig

Korschineck³

et al. 2021

Arch Gynecol Obstet

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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.

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Section: Discussioncontrasting

confidence: 55%

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

Legler

Lührig

Korschineck³

et al. 2021

Arch Gynecol Obstet

View full text Add to dashboard Cite

show abstract

“…In contrast, another study performed in 10-14 wg did not observe false negative results in 416 serum samples (2.2% inconclusive). However, the speci city of an assay based on replicate testing of RHD exon 10 with 95.2% was lower than in the previous studies [32]. In our performance evaluation study the sensitivity of 99.93% and speci city of 99.61% were as high as sensitivities and speci cities determined in the second trimester with large-scale screening studies [14,21,29,33].…”

Section: Discussioncontrasting

confidence: 53%

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

Legler

Lührig

Korschineck³

et al. 2021

Preprint

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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.

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“…This is an ongoing area of research and guidance may change in the coming years. Studies have pointed to both the accuracy, [50][51][52] and potential cost savings [53][54][55] of noninvasive fetal genotyping for RhD and targeted administration of anti-D immune globulin, while others have raised concerns of its effectiveness 56,57 and cost. 58,59…”

Section: Paternal Rhd Genotypingmentioning

confidence: 99%

Prevention of RhD Alloimmunization: A Comparison of Four National Guidelines

et al. 2017

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Diagnostic accuracy of fetal rhesus D genotyping using cell-free fetal DNA during the first trimester of pregnancy

Cited by 23 publications

References 25 publications

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

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

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

Prevention of RhD Alloimmunization: A Comparison of Four National Guidelines

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