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  • Title: Five recent urinary tests for early pregnancy evaluated.
    Author: Ryder KW, Munsick RA, Oei TO, Young PC, Blackford HF.
    Journal: Clin Chem; 1983 Oct; 29(10):1812-4. PubMed ID: 6616829.
    Abstract:
    We evaluate five tests developed for the earlier detection of pregnancy, either in the clinical laboratory or by the patient in her home. These tests offer no advantage over other urinary pregnancy tests, and the results are distinctly inferior to those reported (Clin. Chem. 29: 561-563, 1983) for some serum tests for pregnancy. 5 urinary tests developed for earlier detection of pregnancy were evaluated. 1 of these tests, Early-In-Home Pregnancy Test (e.p.t.), was developed for home pregnancy testing; the other 4 (Preg/Stat, Betacept, Sensi-Tex, and Sensi-Slide) are laboratory tests alleged by the manufacturers to have greater sensitivity than has been associated with such tests in the past. Urine samples were obtained from 59 control subjects known not to be pregnant and 29 patients with a wide range of gestational ages and serum human choriogonadotropin (hCG) concentrations who were being treated at a pregnancy termination clinic. The specificity and sensitivity of each test was determined. Betacept, Sensi-Tex, Sensi-Slide, and e.p.t. had specificity rates of 97-100%, which is consistent with the results reported for other pregnancy tests. For Preg/Stat, however, only 90% of the results were negative for nonpregnant subjects, yielding an unacceptabily high 10% false-positive rate. On the other hand, the Preg/Stat test was the most sensitive, providing a positive result for all urine specimens from patients whose beta-hCG concentrations exceeded 1000 IU/l of serum. Betacept was the next most sensitive, giving results equivalent to those reported for tube-type pregnancy tests. Betacept is not recommended for routine use because of the major technical problems associated with isotopic laboratory tests. The percentage of correct values for the remaining 3 tests was poorer than would be expected for most of the currently available tube-type pregnancy tests. It is concluded that the 5 tests evaluated in this study offer no advantage over other urinary tests, and the results are distinctly inferior to those reported for some serum tests of pregnancy.
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