title: Comparative evaluation of the VERSANT HIV-1 RNA 1.0 kinetic PCR molecular system (kPCR) for the quantification of HIV-1 plasma viral load.
abstract: BACKGROUND
  New automated and ultrasensitive assays are becoming available to monitor HIV-1 plasma viral load, which is an essential marker for the clinical follow-up.
  
  
  OBJECTIVE
  To evaluate the performances of the VERSANT HIV-1 RNA 1.0 (kPCR) automated assay in a clinical laboratory setting.
  
  
  METHODS
  Frozen plasma samples from various HIV-1 subtypes, previously analysed with the VERSANT HIV-1 RNA 3.0 (bDNA) in clinical routine, were retested with the new VERSANT kPCR assay. A comparison was also done with two other commercial assays (NucliSens EasyQ HIV-1 and Abbott real time HIV-1).
  
  
  RESULTS
  We observed a good correlation between the viral load measurements obtained with the kPCR assay and the other techniques. Nevertheless, in terms of absolute quantification, we observed discrepancies of more than 0.5 log cop/ml plasma with 36%, 35% and 0% of the samples respectively with NucliSens EasyQ, VERSANT bDNA 3.0 and Abbott real time. No HIV-1 negative sample was amplified by the kPCR. Tenfold dilutions of samples from HIV-1 subtypes A-D, F-H, K, CRF01, CRF02 and CRF06 were analysed to evaluate the kPCR efficiency: the amplification had an efficiency close to the maximum of 2 for each of the subtypes tested.
  
  
  CONCLUSIONS
  The VERSANT HIV-1 RNA 1.0 assay (kPCR) is suitable for use in a clinical setting with various HIV-1 subtypes. The plasma viral load quantifications obtained with the kPCR assay were close to those obtained with the Abbott real time HIV-1 assay.
authors.affiliation: Université Catholique de Louvain, AIDS Reference Laboratory, Brussels, Belgium. jean.ruelle@uclouvain.be
authors.forename: Jean
authors.initials: J
authors.lastname: Ruelle
authors.forename: Karima
authors.initials: K
authors.lastname: Jnaoui
authors.forename: Isabelle
authors.initials: I
authors.lastname: Lefèvre
authors.forename: Najet
authors.initials: N
authors.lastname: Lamarti
authors.forename: Patrick
authors.initials: P
authors.lastname: Goubau
mesh_terms: D015658:HIV Infections / Q000821:virology*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D010949:Plasma / Q000821:virology*; D016133:Polymerase Chain Reaction / Q000379:methods*; D012367:RNA, Viral / Q000097:blood*; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D019562:Viral Load / Q000379:methods*
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic