title: Detection and quantification of HIV-1 RNA with a fully automated transcription-mediated-amplification assay.
abstract: Nucleic acid testing is the major method used to monitor HIV viral load. Commercial systems based on real-time PCR assays are available for high-volume centralized laboratory testing, but they are not fully automated.
  
  
  
  We have compared the diagnostic performance of the Hologic Aptima HIV-1 Quant Dx assay (Aptima) (based on real-time TMA) on the Panther instrument, a fully-automated random access platform, to that of, the Roche Cobas Ampliprep Cobas TaqMan (CAP/CTM) HIV-1 version 2.0 (based on real-time PCR).
  
  
  
  Probit analysis of replicate dilutions of NIBSC WHO International HIV-1 Standard, gave LODs of 8.6 c/ml for Aptima and 15.2 c/ml for CAP/CTM. The agreement between the assays was excellent when measuring HIV RNA in a calibrated reference (κ=0.90, p<0.001) and good when measuring clinical samples (κ=0.62, p<0.001). The correlation among the samples quantified by the two methods was very good (r=0.95, p<0.001) and the mean difference between the values obtained with the two assays was 0.02 log c/ml for B and non-B subtypes. The vast majority of results showed <0.5 log variance between the two assays (89%); only one sample showed results that differed by over 1.0 log c/ml.
  
  
  
  The performance of the new fully automated Aptima assay is adequate for clinical monitoring of HIV-1 RNA during infections and treatment. The Aptima assay is well suited for routine laboratory use.
authors.affiliation: INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse, France; CHU Toulouse, Hôpital Purpan, Laboratoire de Virologie, Institut Fédératif de Biologie, Toulouse, France. Electronic address: saune.k@chu-toulouse.fr.
authors.forename: K
authors.initials: K
authors.lastname: Sauné
authors.affiliation: INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse, France; CHU Toulouse, Hôpital Purpan, Laboratoire de Virologie, Institut Fédératif de Biologie, Toulouse, France.
authors.forename: S
authors.initials: S
authors.lastname: Raymond
authors.affiliation: CHU Toulouse, Hôpital Purpan, Laboratoire de Virologie, Institut Fédératif de Biologie, Toulouse, France.
authors.forename: J
authors.initials: J
authors.lastname: Boineau
authors.affiliation: INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse, France; CHU Toulouse, Hôpital Purpan, Laboratoire de Virologie, Institut Fédératif de Biologie, Toulouse, France.
authors.forename: C
authors.initials: C
authors.lastname: Pasquier
authors.affiliation: INSERM, U1043, Centre de Physiopathologie de Toulouse Purpan, Toulouse, France; CHU Toulouse, Hôpital Purpan, Laboratoire de Virologie, Institut Fédératif de Biologie, Toulouse, France.
authors.forename: J
authors.initials: J
authors.lastname: Izopet
mesh_terms: D057205:Automation, Laboratory; D015658:HIV Infections / Q000175:diagnosis / Q000821:virology*; D015497:HIV-1 / Q000235:genetics* / Q000302:isolation & purification*; D006801:Humans; D057230:Limit of Detection; D021141:Nucleic Acid Amplification Techniques / Q000295:instrumentation / Q000379:methods; D012367:RNA, Viral / Q000097:blood* / Q000235:genetics / Q000302:isolation & purification; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction / Q000295:instrumentation / Q000379:methods; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D019562:Viral Load
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic
keywords: Aptima HIV Quant Dx assay; HIV RNA quantification; Lower limit of detection; Roche CAP/CTM HIV-1 version 2.0