BACKGROUND: Despite FDA approval and CE marking of commercial tests, manufacturer independent testing of technical aspects is important. OBJECTIVES: To evaluate the analytical performance of the new Abbott RealTime HCV and HIV-1 viral load tests. STUDY DESIGN: 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. CONCLUSION: 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.
BACKGROUND: Despite FDA approval and CE marking of commercial tests, manufacturer independent testing of technical aspects is important. OBJECTIVES: To evaluate the analytical performance of the new Abbott RealTime HCV and HIV-1 viral load tests. STUDY DESIGN: 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. CONCLUSION: 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: M F C Beersma; G M G M Verjans; H J Metselaar; A D M E Osterhaus; W R Berrington; G J van Doornum Journal: J Viral Hepat Date: 2010-08-12 Impact factor: 3.728
Authors: Lesley E Scott; Lara D Noble; Jackie Moloi; Linda Erasmus; Willem D F Venter; Wendy Stevens Journal: J Clin Microbiol Date: 2009-05-06 Impact factor: 5.948
Authors: Johannes Vermehren; Annika Kau; Barbara C Gärtner; Reinhild Göbel; Stefan Zeuzem; Christoph Sarrazin Journal: J Clin Microbiol Date: 2008-09-17 Impact factor: 5.948
Authors: Robert Strassl; Karoline Rutter; Albert Friedrich Stättermayer; Sandra Beinhardt; Michael Kammer; Harald Hofer; Peter Ferenci; Theresia Popow-Kraupp Journal: PLoS One Date: 2015-08-14 Impact factor: 3.240