title: Fully automated quantification of human immunodeficiency virus (HIV) type 1 RNA in human plasma by the COBAS AmpliPrep/COBAS TaqMan system.
abstract: BACKGROUND
  HIV-1 RNA is a key parameter for reliable diagnosis and treatment of HIV-1 infection. The determination of HIV-1 RNA reduces the pre-seroconversion period in the diagnosis of HIV-1 infection and supports clinical management of HIV-1-infected patients.
  
  
  OBJECTIVE
  The COBAS AmpliPrep/COBAS TaqMan HIV-1 Test combines automated extraction of total nucleic acids on the COBAS AmpliPrep Instrument with real-time PCR on the COBAS TaqMan Analyzer, thus greatly reducing hands-on time during sample preparation and amplification/detection. The test was evaluated for sensitivity, dynamic range, precision, subtype inclusivity, interfering substances, diagnostic and analytical specificity, as well as correlation with three other commercial tests for HIV-1 RNA quantification.
  
  
  RESULTS
  The COBAS AmpliPrep/COBAS TaqMan HIV-1 Test demonstrated an assay sensitivity of 40 copies/mL, a greater than 5 log(10) measuring range of 40-1.0E+07 copies/mL (1.6-7.0 log(10)) and a reliable determination of HIV-1 group M and N subtypes in EDTA plasma. Quantification results were highly correlated with those obtained by the COBAS AMPLICOR HIV-1 MONITOR Test v1.5, the COBAS AmpliPrep/COBAS AMPLICOR HIV-1 MONITOR Test v1.5 and the VERSANT HIV-1 RNA 3.0 assay.
  
  
  CONCLUSIONS
  The COBAS AmpliPrep/COBAS TaqMan HIV-1 Test excellently satisfies the requirements for reliable quantification of HIV-1 RNA in clinical specimens by a broad linear measuring range and a fully automated quantification procedure. It is highly appropriate for therapy monitoring and routine management of HIV-1 infection.
authors.affiliation: Roche Molecular Diagnostics, Roche Diagnostics GmbH, Werk Penzberg, Nonnenwald 2, 82377 Penzberg, Germany. wolfram.schumacher@roche.com <wolfram.schumacher@roche.com>
authors.forename: Wolfram
authors.initials: W
authors.lastname: Schumacher
authors.forename: Edmund
authors.initials: E
authors.lastname: Frick
authors.forename: Mirko
authors.initials: M
authors.lastname: Kauselmann
authors.forename: Viola
authors.initials: V
authors.lastname: Maier-Hoyle
authors.forename: Reinier
authors.initials: R
authors.lastname: van der Vliet
authors.forename: Reiner
authors.initials: R
authors.lastname: Babiel
mesh_terms: D000704:Analysis of Variance; D015658:HIV Infections / Q000175:diagnosis / Q000821:virology; D015497:HIV-1 / Q000235:genetics*; D006801:Humans; D010949:Plasma / Q000821:virology*; D016133:Polymerase Chain Reaction / Q000379:methods*; D012367:RNA, Viral / Q000097:blood*; D012680:Sensitivity and Specificity; D019562:Viral Load / Q000379:methods*
chemical_list: D012367:RNA, Viral