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Related Experiment Videos

Screening for Down syndrome pregnancy using beta-core fragment: prospective study

T Isozaki1, G E Palomaki, R O Bahado-Singh

  • 1Department of Obstetrics and Gynaecology, Yale University School of Medicine, New Haven, CT, USA.

Prenatal Diagnosis
|May 1, 1997
PubMed
Summary

Urine beta-core fragment shows promise for screening Down syndrome pregnancies. This prospective study found a 62% detection rate, comparable to serum tests, suggesting potential to replace current methods.

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Area of Science:

  • Biochemistry
  • Genetics
  • Maternal-Fetal Medicine

Background:

  • Previous retrospective studies suggested urine beta-core fragment is a superior screening test for Down syndrome.
  • These studies reported high detection rates but used samples from different sites for cases and controls.

Purpose of the Study:

  • To prospectively evaluate the performance of urine beta-core fragment measurements as a screening test for Down syndrome.
  • To determine the sensitivity and specificity in a single-center, prospective setting.

Main Methods:

  • Prospective collection of urine samples from 726 pregnancies over 9 months at a single medical center.
  • Continuous assay of fresh urine samples for beta-core fragment levels, blinded to karyotype.
  • Analysis of 709 unaffected samples and 13 Down syndrome cases.

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Main Results:

  • Urinary beta-core fragment levels declined throughout pregnancy in unaffected cases, with a logarithmic fit optimal for the median curve.
  • All 13 Down syndrome cases had levels exceeding 1.0 MOM (median 4.1 MOM).
  • Eight of 13 Down syndrome cases (62% sensitivity) exceeded the 95th centile for unaffected pregnancies.

Conclusions:

  • This prospective study confirms the utility of urine beta-core fragment for Down syndrome screening.
  • The observed 62% sensitivity may better reflect real-world clinical performance compared to previous retrospective studies.
  • Urine beta-core fragment tests may offer an alternative or replacement for current serum-based screening methods.