First trimester contingent test as a screening method for Down's syndrome. A prospective study in the general population

J Matern Fetal Neonatal Med. 2012 Nov;25(11):2221-4. doi: 10.3109/14767058.2012.684168. Epub 2012 May 2.

Abstract

Objectives: To evaluate the possibility of implementing a contingent test as a screening method for Down's syndrome (DS) in the first trimester of pregnancy, and assess its sensitivity (Sen) and false positive rate (FPR).

Methods: Prospective study covering a 4-year study period (July 2006-June 2010). Pregnant women were offered a combined test (CT) as the first step of a contingent test. An intermediate risk group is identified in the CT (1/101 and 1/1000) and offered an ultrasound assessment of secondary s (nasal bone, ductus venosus, tricuspid regurgitation).

Results: CTs were performed on 10,452 pregnant women (24 cases of DS). In the intermediate risk group, which had 7 cases of DS, we performed secondary ultrasound marker assessment on 98.1% (1,017/1,036). The CT and the contingent test had a Sen of 83% (95% CI; 67.9-98) (20/24) and 70.8% (95% CI; 52.6-88.9) (17/24) with an FPR of 3% (95% CI; 2.7-3.3) (316/10,430) and 2% (95% CI; 1.7-2.3) (220/10,408), respectively.

Conclusions: With the contingent test, we managed to reduce the FPR, but the Sen was too low for use as a screening method for DS.

Publication types

  • Evaluation Study

MeSH terms

  • Algorithms
  • Biomarkers / analysis
  • Biomarkers / blood
  • Cytogenetic Analysis
  • Down Syndrome / diagnosis*
  • Down Syndrome / epidemiology
  • Female
  • Humans
  • Infant, Newborn
  • Mass Screening* / methods
  • Population
  • Pregnancy
  • Pregnancy Trimester, First* / blood
  • Pregnancy Trimester, First* / physiology
  • Prenatal Diagnosis / methods*
  • Prospective Studies
  • Spain / epidemiology

Substances

  • Biomarkers