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  • Title: Evaluation of the beta-Neocept test for early pregnancy.
    Author: Yuen BH, Pride SM, Callegari PB.
    Journal: Can Med Assoc J; 1984 Sep 15; 131(6):583-5. PubMed ID: 6206935.
    Abstract:
    We tested the validity of the beta-Neocept test for early pregnancy against that of the plasma human chorionic gonadotropin beta-subunit radioimmunoassay (beta-HCG RIA). The beta-Neocept test had a sensitivity of 88%, a specificity of 93%, a positive predictive value of 95%, a negative predictive value of 84% and an accuracy of 90%. In view of these performance characteristics, its low cost and its ease of use, the beta-Neocept test could be used as the initial pregnancy test when there is a high probability of pregnancy, as there was in this study population, which consisted of 111 women attending endocrine infertility clinics. The more expensive beta-HCG RIA could be reserved for special indications and for patients in whom the results of the urinary hemagglutination inhibition tests are inconsistent with the clinical signs and symptoms. Paired urine and blood samples from 111 women attending endocrine infertility clinics in Vancouver, Canada, were used to compare the validity of the beta-Neocept test for early pregnancy against that of the plasma human chorionic gonadotropin beta-subunit radioimmunoassay (beta-HCG-RIA). None of the urine specimens contained glucose, 1 specimen contained 1 + protein measured by dipstick, and 1 contained a large amount of blood. 67 patients were pregnant and 44 were not pregnant. Beta-Neocept test results were positive for 59 pregnant patients, negative for 8 pregnant patients, positive for 3 nonpregnant patients, and negative for 41 nonpregnant patients. There were 62 positive and 49 negative tests. Results with the Beta-Neocept test became positive as early as the 28th day after the onset of the last menstrual period and negative results occurred with plasma beta-HCG levels ranging between 5 and 157 IU/1. The sensitivity of the Beta-Neocept test was 88%, the specificity 93%, the positive predictive value 95%, the negative predictive value 84%, and the overall accuracy 90%. The 8 false-negative results all occurred at low plasma beta-HCG levels. The false-negatives occurred in 1 patient on no medication, 1 taking clomiphene citrate and prednisone, 1 taking gonadotropin releasing hormone (GRH), 1 taking human menopausal gonadotropin and human chorionic gonadotropin, 1 taking GRH and bromocriptine mesylate, 1 taking clomiphene citrate alone, and 2 taking clomiphene citrate and progesterone vaginal inserts. The 3 false-positive results occurred in 2 patients using progesterone vaginal inserts for luteal-phase support and 1 who was taking clomiphene citrate. The results indicate that the Beta-Neocept test is sensitive and specific, and would be an appropriate initial test for patients with a high probability of pregnancy. The beta-HCG-RIA could be reserved for patients in whom the results of the less expensive and less difficult Beta-Neocept were inconsistent with clinical signs and symptoms.
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