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  • Title: Evaluation of a new pregnancy test claiming beta-subunit specificity.
    Author: Isikoff SK, Civantos F, Deforge MJ.
    Journal: Am J Clin Pathol; 1980 Jul; 74(1):98-100. PubMed ID: 7395822.
    Abstract:
    A new hemagglutination-inhibition tube test for human chorionic gonadotropin said to be beta-subunit specific was compared with a widely used similar test that is not beta-specific. Also compared were the latex agglutination-inhibition slide test from the same manufacturer, along with a similar non-beta-subunit specific slide test. Although the new tube test showed good sensitivity, false-positives still occurred in the perimenopausal age group. A comparison was made between a new hemagglutination-inhibition tube test for human chorionic gonadotropin said to be beta-subunit specific and a widely used similar test that is not beta specific. The latex agglutination-inhibition slide test from the same manufacturer and a similar non-beta-subunit specific slide test were also compared. The study group was made up of random urine specimens submitted for pregnancy tests for 251 patients at a large county hospital in Miami, Florida. The tests were conducted between April and August 1978 among a group of patients who had a large variety of problems, including menstrual and hormonal irregularities, acute vaginal bleeding, or abdominal emergencies. The directions of the manufacturers were followed for the 4 pregnancy kits evaluated. The test results were recorded as either positive or negative. Of the 251 patients tested, 48 were pregnant, 161 were not pregnant, and 43 had insufficient follow-up for diagnosis. For 37 of the 48 patients with clinical or tissue diagnoses of pregnancy, all 4 of the tests were performed and were positive. 135 nonpregnant patients had negative results for all 4 tests. 8 patients who were pregnant had negative results by either 1 or more of the 4 tests, and the majority of the false-negatives were for those who were in early pregnancy or for patients who were aborting. The new tube test showed good sensitivity, but false-positives still occurred in the perimenopausal age group.
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