Clinical evaluation of two urine tests for the early diagnosis of pregnancy.

We compared the performance of two immunologic tests for hCG in urine with a qualitative serum hCG assay. The latex agglutination assay ( Sensi -Tex) was found to be superior to a hemagglutination assay (Beta-Stat) in that fewer equivocal results were obtained with it. Excluding equivocal results, both urine tests agreed well with the results of the serum qualitative hCG assay. Interference by human menopausal gonadotropins occurred at higher concentrations with Sensi -Tex than with Beta-Stat, suggesting that the Sensi -Tex reagents have greater specificity. We recommend that laboratories examine the performance of available urine pregnancy tests on site before selecting a reagent system for routine use.