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False-positive rates in screening for trisomies 18 and 13: a comparison between first-trimester combined screening and a cfDNA-based approach.
Kagan, Karl Oliver; Sonek, Jiri; Sroka, Andreas; Abele, Harald; Wagner, Philipp; Prodan, Natalia; Hoopmann, Markus.
Afiliación
  • Kagan KO; Department of Women's Health, University Women's Hospital Tuebingen, Calwerstrasse 7, 72076, Tübingen, Germany. KOKagan@gmx.de.
  • Sonek J; Fetal Medicine Foundation USA, Dayton, OH, USA.
  • Sroka A; Division of Maternal-Fetal Medicine, Wright State University, Dayton, OH, USA.
  • Abele H; Department of Women's Health, University Women's Hospital Tuebingen, Calwerstrasse 7, 72076, Tübingen, Germany.
  • Wagner P; Department of Women's Health, University Women's Hospital Tuebingen, Calwerstrasse 7, 72076, Tübingen, Germany.
  • Prodan N; Department of Women's Health, University Women's Hospital Tuebingen, Calwerstrasse 7, 72076, Tübingen, Germany.
  • Hoopmann M; Department of Women's Health, University Women's Hospital Tuebingen, Calwerstrasse 7, 72076, Tübingen, Germany.
Arch Gynecol Obstet ; 299(2): 431-437, 2019 02.
Article en En | MEDLINE | ID: mdl-30519751
PURPOSE: To determine the false-positive rates (FPR) associated with screening for trisomy 18/13 using first-trimester combined screening (FTCS) and an ultrasound plus cfDNA-based approach (US-cfDNA), which includes a detailed ultrasound examination, a cfDNA analysis and a FTCS reflex backup test for cases with uninformative results. METHODS: This is a sub-analysis of a randomized controlled trial, which was performed between 2015 and 2016. Pregnant women with a normal first-trimester ultrasound examination at 11-13 weeks' gestation (NT < 3.5 mm, no anomalies) were randomized into two groups: FTCS and US-cfDNA screening. The overall FPR in screening for trisomies 18/13 and 21 was compared with the FPR in screening for trisomy 21 alone. Pregnancies were considered screen positive if the risk for trisomy 21 was 1:100 and for trisomy 18 and 13, 1:20 each. RESULTS: The study population consisted of 688 pregnancies in each study arm. In the FCTS group, median delta NT was 0.0 mm, free beta-hCG and PAPP-A 0.96 and 1.11 MoM. In the US-cfDNA group, median delta NT was 0.0 mm. In 10 pregnancies, the cfDNA analysis was uninformative. In the FTCS and in the US-cfDNA group, the FPR in screening for trisomy 21 was 2.5% and 0%. In both groups, the overall FPR was not increased by adding screening algorithms for trisomies 18 and 13. CONCLUSION: In conclusion, the addition of screening for trisomies 18 and 13 to screening for trisomy 21 does not significantly change FPR. This is true for both the FTCS and the US-cfDNA-based approach.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tamizaje Masivo / Síndrome de la Trisomía 13 / Síndrome de la Trisomía 18 / Ácidos Nucleicos Libres de Células Tipo de estudio: Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies / Screening_studies Límite: Adult / Female / Humans / Pregnancy Idioma: En Revista: Arch Gynecol Obstet Asunto de la revista: GINECOLOGIA / OBSTETRICIA Año: 2019 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Alemania
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Tamizaje Masivo / Síndrome de la Trisomía 13 / Síndrome de la Trisomía 18 / Ácidos Nucleicos Libres de Células Tipo de estudio: Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies / Screening_studies Límite: Adult / Female / Humans / Pregnancy Idioma: En Revista: Arch Gynecol Obstet Asunto de la revista: GINECOLOGIA / OBSTETRICIA Año: 2019 Tipo del documento: Article País de afiliación: Alemania Pais de publicación: Alemania