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

Cole, Laurence A. and Kellner, Leonard H. and Isozaki, Taichi and Palomaki, Glenn E. and Iles, Ray K. and Walker, Roger P. and Ozaki, Mikio and Canick, Jacob A. (1997) Comparison of 12 assays for detecting hCG and related molecules in urine samples from Down syndrome pregnancies. Prenatal diagnosis, 17 (7). pp. 607-614. ISSN 0197-3851

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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.

Item Type:Article
Research Areas:Middlesex University Schools and Centres > School of Science and Technology > Natural Sciences
Citations on ISI Web of Science:14
ID Code:3487
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Deposited On:22 Dec 2009 09:21
Last Modified:06 Feb 2013 11:45

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