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A comparative evaluation of ELISA and latex agglutination tests for detection of human chorionic gonadotropin (hCG) in urine for pregnancy.


 To resolve questions about the relative sensitivity and specificity of the latex agglutination and enzyme-linked immunosorbent assay (ELISA) for the detection of human chorionic gonadotropin (hCG) in pregnancy, urine samples from 265 cases of suspected pregnancy were tested simultaneously by both methods. Included in the sample were women whose menstrual period ranged from 5-60 days late. In 243 cases (92%), identical results were obtained with both tests (142 positive and 101 negative). In an additional 12 cases, urine samples containing low levels of hCG when tested by the latex agglutination test showed negative results, while the same samples showed positive pregnancy (subsequently confirmed clinically) when tested by ELISA. Finally, 10 urine samples with red blood cells or pus cells gave false positive results on the latex agglutination test, but these cells did not interfere in the ELISA test. The lag period after the last menstrual period was 5-7 days for ELISA compared with 20 days for the latex agglutination test. The sensitivity of the former test was 0.5 IU hCG/ml of urine and 3.5 IU hCG/ml of urine for the latter test. Other advantages of the ELISA test are its stability (reagents are stable at room temperature, while those of the latex agglutination test are not), and its very clear and easy to read end point. The only advantage of the latex agglutination test was the time required for performing the test (5 minutes, compared with 40-50 minutes for ELISA).
