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M94A1837.TXT
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1994-10-24
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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
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).