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Area of Science:

  • Prenatal diagnostics
  • Maternal serum screening
  • Genetic disorders

Background:

  • Down's syndrome, a common cause of congenital mental disability, results from an extra copy of chromosome 21.
  • Screening tests estimate the risk of Down's syndrome, guiding decisions for definitive testing.
  • No current test predicts the severity of Down's syndrome in affected individuals.

Purpose of the Study:

  • To evaluate and compare the accuracy of first-trimester serum markers for Down's syndrome detection.
  • To assess individual markers and marker combinations for antenatal screening.
  • To define accuracy by sensitivity (detection rate) and specificity (low-risk result rate).

Main Methods:

  • Comprehensive literature search of multiple databases (MEDLINE, Embase, etc.) from 1980 to August 2011.
  • Inclusion of studies with index tests compared to a reference standard (chromosomal verification or postnatal inspection).
  • Meta-analysis using hierarchical summary ROC or random-effects logistic regression to analyze test performance.

Main Results:

  • 56 studies involving 204,759 pregnancies (2113 with Down's syndrome) were analyzed.
  • Evaluated 78 test combinations using 18 different biochemical markers and maternal age.
  • A combination of PAPP-A, free βhCG, and maternal age detected 70% of Down's syndrome cases with a 5% false positive rate.

Conclusions:

  • Two-marker combinations with maternal age (PAPP-A, free βhCG) are superior to single markers for Down's syndrome screening.
  • Triple tests did not show statistically significant superiority in the included studies.
  • Screening blood tests are safe, but invasive follow-up tests carry a risk of miscarriage.