       Document 1219
 DOCN  M9591219
 TI    Clinical evaluation of Amplicor HIV-1 test for detection of human
       immunodeficiency virus type 1 proviral DNA in peripheral blood
       mononuclear cells.
 DT    9509
 AU    Khadir A; Coutlee F; Saint-Antoine P; Olivier C; Voyer H; Kessous-Elbaz
       A; Departement de Microbiologie et Maladies Infectieuses, Hopital;
       Notre-Dame, Montreal, PQ, Canada.
 SO    J Acquir Immune Defic Syndr Hum Retrovirol. 1995 Jul 1;9(3):257-63.
       Unique Identifier : AIDSLINE MED/95308201
 AB    We report here the clinical evaluation of Amplicor polymerase chain
       reaction (PCR) assay for the detection of the human immunodeficiency
       virus type 1 (HIV-1) in peripheral blood mononuclear cells (PBMCs).
       Results obtained with Amplicor HIV-1 test were compared to serological
       status and a standard PCR assay using SK38/SK39 and oligomer
       hybridization with SK19. A panel of 208 well-characterized specimens was
       analyzed, including PBMC lysates from 47 antibody-negative high-risk
       individuals, eight antibody-negative low-risk subjects, two subjects
       with acute retroviral disease, 35 asymptomatic seropositive subjects (59
       samples) with CD4 counts > 400/mm3, 31 patients (46 samples) with
       AIDS-related complex (ARC), 30 patients (40 specimens) with AIDS, and
       six seropositive patients with unknown clinical status. Amplicor
       demonstrated a specificity of 100% and a sensitivity of 98.7%. Of the
       two false-negative samples with Amplicor, one was negative for
       beta-globin amplification, whereas a dilution of the other sample turned
       positive for HIV-1. Inhibitors of Taq polymerase were thus believed to
       be responsible for the negative results. This study demonstrates that
       commercialized nonisotopic PCR assays reach adequate levels of
       sensitivity and specificity for diagnosis of HIV-1 infection and could
       be considered in clinical situations in which serology is not helpful.
 DE    Acquired Immunodeficiency Syndrome/DIAGNOSIS/VIROLOGY  AIDS-Related
       Complex/DIAGNOSIS/VIROLOGY  DNA, Viral/*BLOOD  Evaluation Studies  False
       Positive Reactions  Human  HIV Infections/*DIAGNOSIS/VIROLOGY
       HIV-1/*GENETICS/PHYSIOLOGY  Leukocytes, Mononuclear/*VIROLOGY
       Polymerase Chain Reaction/METHODS  Predictive Value of Tests
       Prospective Studies  Proviruses/*GENETICS  Reagent Kits, Diagnostic
       Sensitivity and Specificity  Support, Non-U.S. Gov't  JOURNAL ARTICLE

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

