       Document 0447
 DOCN  M9440447
 TI    Establishment of a quality assurance program for human immunodeficiency
       virus type 1 DNA polymerase chain reaction assays by the AIDS Clinical
       Trials Group. ACTG PCR Working Group, and the ACTG PCR Virology
       Laboratories.
 DT    9404
 AU    Jackson JB; Drew J; Lin HJ; Otto P; Bremer JW; Hollinger FB; Wolinsky
       SM; Institute of Pathology, Case Western Reserve University,; Cleveland,
       Ohio 44106.
 SO    J Clin Microbiol. 1993 Dec;31(12):3123-8. Unique Identifier : AIDSLINE
       MED/94140978
 AB    An independent quality assurance program has been established by the
       Virology Committee of the AIDS Clinical Trials Group in the Division of
       AIDS, National Institute of Allergy and Infectious Diseases, for
       monitoring polymerase chain reaction (PCR) assays for human
       immunodeficiency virus type 1 (HIV-1) DNA that are performed by 11
       laboratories participating in multicenter clinical trials in the United
       States. To perform HIV-1 DNA PCR for patients in AIDS Clinical Trials
       Group protocols, each laboratory was initially certified by correctly
       testing a coded certification panel consisting of eight well-defined
       clinical whole-blood specimens and 30 cell pellets containing 0, 2, 5,
       10, 20, or 50 8E5/LAV cells per 125,000 uninfected peripheral blood
       mononuclear cells. PCR was performed by one of two standardized
       commercial assays for amplification and nonisotopic detection of HIV-1
       proviral DNA. For continuing certification, each laboratory must
       correctly test eight coded whole-blood samples per quarter and run three
       or four coded cell pellets and HIV-1 DNA copy standards with every PCR
       assay in real time. The PCR results for the coded pellets on each run
       are entered into an encrypted computer file, which immediately assesses
       the validity of the run. To date, 10 of 11 laboratories have correctly
       tested all HIV-1-positive and -negative samples in the initial
       certification panel on their first or second attempt. Subsequently, 9 of
       these 11 laboratories have continued to maintain their certified
       status.(ABSTRACT TRUNCATED AT 250 WORDS)
 DE    Certification  Clinical Trials  Diagnostic Errors  Genes, gag  Human
       HIV Infections/DIAGNOSIS/MICROBIOLOGY  HIV-1/*GENETICS/ISOLATION & PURIF
       Laboratories  Multicenter Studies  National Institutes of Health (U.S.)
       Polymerase Chain Reaction/METHODS/STATISTICS & NUMER DATA/  *STANDARDS
       Quality Control  Sensitivity and Specificity  Support, Non-U.S. Gov't
       Support, U.S. Gov't, P.H.S.  United States  JOURNAL ARTICLE

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

