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).