Document 0630
 DOCN  M9650630
 TI    Performance of a rapid, on-site human immunodeficiency virus antibody
       assay in a public health setting.
 DT    9605
 AU    Kassler WJ; Haley C; Jones WK; Gerber AR; Kennedy EJ; George JR;
       Division of STD/HIV Prevention, Centers for Disease Control and;
       Prevention, Atlanta, Georgia, USA.
 SO    J Clin Microbiol. 1995 Nov;33(11):2899-902. Unique Identifier : AIDSLINE
       MED/96121237
 AB    Rapid, on-site human immunodeficiency virus (HIV) testing has the
       potential to improve the delivery of prevention services in publicly
       funded counseling and testing sites. The Single Use Diagnostic System
       (SUDS) HIV-1 is the only rapid enzyme immunoassay (EIA) approved for
       diagnostic use in the United States. To evaluate the feasibility of
       using SUDS in public clinics and to validate the test's performance in a
       public health laboratory, we conducted blinded SUDS testing on plasma
       sent for HIV testing. From 19 March through 30 June 1993, 1,923
       consecutive samples from a sexually transmitted diseases clinic and an
       HIV counseling and testing clinic were tested on site with SUDS. Tests
       done in the first two weeks with a malfunctioning centrifuge n = 402)
       and those done when there were excessively high temperatures in the
       laboratory (n = 53) were analyzed separately. Of 1,466 tests, 39 were
       positive by both SUDS and EIA (with Western blot [immunoblot]
       confirmation) and 7 were SUDS positive and EIA negative. Western
       blotting was used as the gold standard to adjudicate these
       discrepancies. There were no SUDS-negative and EIA-positive tests.
       Compared with that of EIA (with Western blot confirmation), the
       sensitivity of SUDS was 100% (95% confidence interval, 88.8 to 100%) and
       the specificity was 99.5% (95% confidence interval, 98.9 to 99.8%). The
       positive predictive value of SUDS was 88% in the STD clinic and 81% in
       the HIV counseling and testing clinic. There was a 7.7-fold increase in
       false positives, from 0.48 to 3.7%, when there was inadequate
       centrifugation and when the temperature exceeded the manufacturer's
       recommendations. Rapid, on-site HIV testing by the SUDS assay is
       feasible and practical in public health settings. The test can be
       performed accurately, at reasonable cost, and within the time frame of a
       typical clinic visit. Caution should be used, however, as two conditions
       adversely affected the accuracy of this test: inadequate specimen
       preparation and elevated temperature.
 DE    Ambulatory Care Facilities  AIDS Serodiagnosis/*METHODS  Blotting,
       Western  Human  HIV Infections/*DIAGNOSIS/EPIDEMIOLOGY  Immunoenzyme
       Techniques  Laboratories  Mass Screening/*METHODS  *Reagent Kits,
       Diagnostic  Texas/EPIDEMIOLOGY  Time Factors  CLINICAL TRIAL  JOURNAL
       ARTICLE

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