Document 1837
 DOCN  M94A1837
 TI    Study on the clinical usefulness of urine HIV EIA kit. Clinical Study
       Group.
 DT    9412
 AU    Yoshihara N; Yamazaki S; Shimada K; NIH., Tokyo, Japan.
 SO    Int Conf AIDS. 1994 Aug 7-12;10(1):44 (abstract no. 150B). Unique
       Identifier : AIDSLINE ICA10/94370738
 AB    OBJECTIVE AND METHODS: To clarify the usefulness of the Urine HIV EIA
       KIT developed by Calyptebiomedical Corp. (Berkeley, CA), we carried out
       the clinical study on Japanese subjects. After informed consent from
       subjects was obtained, urine and the matched serum specimens were
       collected from 1.078 subjects in total for detection of the HIV-1
       antibody, including 168 HIV-infected patients, 576 healthy individuals,
       90 pregnant women and patients with other diseases. Sera were tested
       with PA and ELISA, and positive serum samples were confirmed by WB.
       Urine specimens were tested with the Urine HIV EIA KIT in comparison
       with the test results of the matched sera. RESULTS: All of the test
       results of the HIV infected were positive in urine and resulted in a
       100% correspondence between serum and urine results. Furthermore, the
       urine samples were clearly identified positive due to the significant
       elevation apart from cutoff value. Of the non-infected groups, healthy
       and pregnant subjects demonstrated false positive at the rate of 0.7%
       and 2.2% respectively and also in some patients with STD and other
       diseases. CONCLUSION: The Urine HIV EIA KIT was evaluated in clinical
       study. The kit performance was assessed to be good useful for screening
       test.
 DE    Comparative Study  Evaluation Studies  False Positive Reactions  Female
       Human  HIV Antibodies/BLOOD/*URINE  HIV Infections/DIAGNOSIS/IMMUNOLOGY
       HIV-1/*IMMUNOLOGY  *Immunoenzyme Techniques  Japan  Mass Screening
       Pregnancy  CLINICAL TRIAL  MEETING ABSTRACT

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