title: Evaluation of the analytical performance of the new Abbott RealTime RT-PCRs for the quantitative detection of HCV and HIV-1 RNA.
abstract: BACKGROUND
  Despite FDA approval and CE marking of commercial tests, manufacturer independent testing of technical aspects is important.
  
  
  OBJECTIVE
  To evaluate the analytical performance of the new Abbott RealTime HCV and HIV-1 viral load tests.
  
  
  METHODS
  Sensitivity, specificity and inter-/intra-assay variation were investigated. The HCV and HIV-1 assays were compared with Siemens bDNA 3.0 and Roche Cobas Monitor 2.0, respectively, on diagnostic samples.
  
  
  RESULTS
  Lower isolation volumes on the M1000 gave minor but statistically significant lower quantitative values. Minor differences were observed in the lower limit of detection relative to the specification given by the manufacturer. Inter-/intra-assay coefficients of variations ranged from 0.31 to 4.75 between 5.0 x 10(4) and 5.0 x 10(2) copies/mL. Both the HCV and HIV-1 Abbott RealTime tests did not show a geno-/sub-type dependent under-quantification on WHO reference panels, quality control panels or clinical specimens. The Abbott RealTime HIV-1 viral load assay detected subtype O whereas several other systems failed to detect this subtype.
  
  
  CONCLUSIONS
  The technical aspects of the HCV and HIV-1 RealTime viral load assays on the M2000 system make it attractive for use in routine diagnostic settings.
authors.affiliation: Erasmus MC, Department of Virology, s-Gravendijkwal 230, 3015 CE, Rotterdam, The Netherlands. m.schutten@erasmusmc.nl
authors.forename: M
authors.initials: M
authors.lastname: Schutten
authors.forename: E
authors.initials: E
authors.lastname: Fries
authors.forename: C
authors.initials: C
authors.lastname: Burghoorn-Maas
authors.forename: H G M
authors.initials: HG
authors.lastname: Niesters
mesh_terms: D015658:HIV Infections / Q000175:diagnosis / Q000821:virology; D015497:HIV-1 / Q000235:genetics / Q000302:isolation & purification*; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006526:Hepatitis C / Q000175:diagnosis / Q000821:virology; D006801:Humans; D016133:Polymerase Chain Reaction / Q000379:methods; D011786:Quality Control; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D012680:Sensitivity and Specificity; D019562:Viral Load
chemical_list: D011933:Reagent Kits, Diagnostic