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[Second trimester Down syndrome serum screening--results from a pilot study].

V Dimitrova1, T Chernev, I Kremenski

  • 1State University Hospital Maichin Dom, Department of Obstetrics and Gynaecology, Medical University, Sofia.

Akusherstvo I Ginekologiia
|June 18, 2002
PubMed
Summary

This pilot study shows that second-trimester Down syndrome (DS) serum screening is effective, achieving high sensitivity and a lower ratio of lost unaffected pregnancies compared to age screening alone.

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Area of Science:

  • Prenatal Diagnostics
  • Biochemistry
  • Genetics

Context:

  • Second-trimester Down syndrome (DS) screening is crucial for prenatal diagnosis.
  • Previous screening methods relied on maternal age and limited biochemical markers.
  • A pilot prospective study evaluated a two-marker serum screening protocol.

Purpose:

  • To assess the sensitivity, false-positive rate (FPR), positive predictive value (PPV), and negative predictive value (NPV) of a two-marker (alpha-fetoprotein and free beta-hCG) serum screening for Down syndrome.
  • To analyze the uptake of invasive prenatal testing in screen-positive cases.
  • To evaluate the ratio of "lost unaffected pregnancies" per diagnosed DS fetus.

Summary:

  • The study achieved high sensitivity for Down syndrome (DS) serum screening (75% and 87.5% in different age groups) with varying false-positive rates (6.6% and 31.7%).

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  • Positive predictive value increased with higher DS risk, while negative predictive value decreased.
  • Uptake for invasive testing was high (83.4%), and all diagnosed DS pregnancies were terminated. The ratio of lost unaffected pregnancies was lower than with age screening.

    • Impact:

    • The study's results are comparable to existing literature, supporting the feasibility of widespread Down syndrome serum screening.
    • This pilot study provides a foundation for introducing a population-wide DS screening program.
    • The findings highlight the effectiveness of serum screening in identifying Down syndrome prenatally with improved efficiency over age-based methods.