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M94A2686.TXT
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Document 2686
DOCN M94A2686
TI Clinical evaluation of Empyrean's simple & rapid HIV-1 test.
DT 9412
AU Akerkar A; Medical Device Inspection Company, Inc., Great Neck, N.Y.
11021.
SO Int Conf AIDS. 1994 Aug 7-12;10(1):248 (abstract no. PB0420). Unique
Identifier : AIDSLINE ICA10/94369889
AB OBJECTIVE: To evaluate performance of Empyrean's Simple & Rapid HIV-1
Test. TEST DESCRIPTION: The test is performed in a small, clear plastic
pouch which contains 2 chambers: reaction and waste collection. The
reaction chamber consists of a clear plastic with 3 mu pores sealed into
the pouch. Below the filter, waste reagents are collected. Reagents are
polystyrene beads (5 mu) coated with recombinant antigen, HRP conjugate,
substrate/chromogen, and wash solution. Positive results indicated by
blue precipitate and negative colorless. In all 560 samples were
analyzed and were previously analyzed by WB method. None of the
technicians were aware of these results. All positive samples were
repeated for confirmation. Out of 560 samples, 187 came as positives,
373 as negatives, 8 as false positives, and zero false negatives.
Ongoing clinical trials are underway and we anticipate to perform assays
of well over 3000. CONCLUSION: Empyrean's Simple & Rapid HIV-1 Test is
very simple to perform and takes 3 minutes per sample for analysis. The
sensitivity of the test is 100% and specificity taken to be 97.9%.
DE AIDS Serodiagnosis/*METHODS Blotting, Western Comparative Study Human
HIV Antibodies/*BLOOD HIV Seropositivity/*DIAGNOSIS/IMMUNOLOGY
HIV-1/*IMMUNOLOGY Predictive Value of Tests *Reagent Kits, Diagnostic
Sensitivity and Specificity MEETING ABSTRACT
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).