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  • Title: Performances of urine pregnancy tests on College of American Pathologists Survey specimens.
    Author: Biesecker JL, Rippey JH.
    Journal: Am J Clin Pathol; 1981 Oct; 76(4 Suppl):544-6. PubMed ID: 7282640.
    Abstract:
    The participant performances on the College of American Pathologists (CAP) Urine Survey specimens distributed during 1979 and 1980 for pregnancy testing are reviewed. Almost all the reagent methods used by the participants performed well on the negative specimens. Prominent differences in results on the positive specimens were found. Awareness by laboratorians of the reagent sensitivity, limitations, and capabilities of commercial tests for determining human chorionic gonadotropin in urine is recommended. Pregnancy tests for human chorionic gonadotropins (hCG) in urine has yielded false-positive and false-negative results. The technical error rate in performing pregnancy tests is 1-4%. This paper presents the results of participant tests on the CAP (College of American Pathologists) Survey specimens. In 1979 and 1980, the CAP prepared 22 urine survey specimens for hCG testing. Radioimmunoassay was used to determine reference levels of hCG in these specimens. 8 negative specimens contained no hCG, 8 low-level specimens contained 0.6-1.0 U/ml, and 6 high-level specimens contained 2.2-3.8 U/ml. Laboratories participating in the CAP Urine Survey Program received and tested these specimens for the presence of hCG using their reagent products of choice and recorded their results as positive or negative. The CAP Computer Center tabulated the results as correct or incorrect according to the assayed levels of hCG within the specimens. 35,014 hCG tests were performed. 58.9% were determined by slide procedures, and 41.1% were determined by tube procedures. Correct results were obtained in 88.2-99.3% of participant tests. Correct results were obtained in 70.8-100% of participant tests on urine specimens containing high levels of hCG (2.2-3.8 U/ml), and in 2.2-96.4% of participant tests on urine specimens containing low levels of hCG (0.6-1.0 U/ml). This study shows that almost all the reagent methods used by participants performed well on the negative specimens. 2 major factors affect the performance of results with various urine pregnancy tests: 1) the sensitivity of the test for hCG detection, and 2) the level of hCG in the specimen. Laboratory workers should develop a high level of awareness of the reagent's sensitivity, limitations, and capabilities of commercial tests for urine hCG.
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