Comparison of 12 assays for detecting hCG and related molecules in urine samples from Down syndrome pregnancies

Prenat Diagn. 1997 Jul;17(7):607-14. doi: 10.1002/(sici)1097-0223(199707)17:7<607::aid-pd118>3.0.co;2-7.

Abstract

Urine is a new medium for Down syndrome testing. In an effort to determine the best type of human chorionic gonadotropin (hCG)-related immunoassay for urine testing, we examined 14 Down syndrome and 91 unaffected pregnancy urine samples with 12 established assays. The assays included (a) those that detect hCG beta-core fragment only; (b) those that detect beta-core fragment with less than 18 per cent free beta-subunit cross-reactivity; (c) that which equally detects free beta-subunit and beta-core fragment; and (d) those that detect hCG, free beta-subunit, or combinations thereof. The seven type a and b assays had the highest sensitivity for Down syndrome. The median MOM for Down syndrome was 5.93 (range 4.73-7.53). At a 10 per cent false-positive rate, the median observed detection rate was 93 per cent (range 79-100 per cent) and the median predicted detection rate was 85 per cent (range 69-96 per cent). The assays that did not mainly detect beta-core fragment (types c and d) had poorer screening performance. The median MOM for Down syndrome was 2.70 (range 2.16-3.63 MOM). At a 10 per cent false-positive rate, the median observed detection rate was 50 per cent (range 36-64 per cent) and the median predicted detection rate was 37 per cent (range 21-62 per cent). We infer that the assays that only detect beta-core fragment, or beta-core fragment with minor free beta-subunit cross-reactivity (types a and b), are the better urine-based tests for Down syndrome screening.

Publication types

  • Comparative Study
  • Multicenter Study

MeSH terms

  • Case-Control Studies
  • Chorionic Gonadotropin / urine*
  • Chorionic Gonadotropin, beta Subunit, Human / urine*
  • Down Syndrome / diagnosis*
  • Female
  • Humans
  • Immunoassay*
  • Predictive Value of Tests
  • Pregnancy
  • Pregnancy Trimester, Second
  • Prenatal Diagnosis / methods*
  • Sensitivity and Specificity

Substances

  • Chorionic Gonadotropin
  • Chorionic Gonadotropin, beta Subunit, Human