Evaluation of Enzyme Immunoassay for Urinary Pregnancy Tests

Ki Sook Hong, Ok Kyung Kim

Copyright ⓒ 1991. Ewha Womans University School of Medicine. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Published Online: Jul 24, 2015

Abstract

Three new developed enzyme immunoassays(EIA) for urinary pregnancy tests were compared with the three older latex agglutination assays(LATEX) in the urine samples of 138 patients.

The examined kits included EIA (Testpack hCG-Urine. Tandem ICON II hCG Urine, Target hCG) and direct LATEX (Betatex direct, Pregnancy Quick test, Synchron hCG).

The results were as follows:

1) The coincidence rate between EIA and direct LATEX is 91%. The coincidence rate between EIA and radioimmunoassay(RIA) is 100%.

2) The range of the discrepancy between EIA and LATEX is 79mlU/ml to 855mlU/ml.

3) When the EIA is considered to be the standard method. the sensitivity and specificity of Latex are 78% and 100%.

4) The hCG of the urine specimen which were found to be negative by EIA and LATEX is below 50mlU/ml.

5) There is no false positive result in proteinuria(2+) and bloody urine(1+) in the EIA and Latex.

We conclude EIA is the nost sensitive procedure(lowest detection limits)for qualitatively detecting hCG in urine samples secreted by early pregnancy.