title: Comparison of the QIAGEN artus HBV QS-RGQ Assay With the Roche COBAS AmpliPrep/COBAS TaqMan HBV Assay for Quantifying Viral DNA in Sera of Chronic Hepatitis B Patients.
abstract: BACKGROUND
  Hepatitis B virus DNA quantification is essential for managing chronic hepatitis B (CHB). We compared the performance of artus HBV QS-RGQ (QIAGEN GmbH, Germany) and CAP/CTM v2.0 HBV assays (Roche Molecular Diagnostics, USA) in CHB patients.
  
  
  METHODS
  A comparative evaluation between two assays was performed with 508 clinical serum samples. Precision, linearity, and the limit of detection (LOD) of QS-RGQ assay was evaluated by using the WHO standard 97/750 and clinical samples.
  
  
  RESULTS
  Detection rates and viral loads as determined QS-RGQ assay were significantly lower than those from the CAP/CTM v2.0 assay (52.8% vs 60.6%; 3.55±1.77 IU/mL vs 4.18±1.89 IU/mL, P<0.0001). The kappa coefficient between qualitative results was 0.79 (95% confidence interval, 0.74 to 0.85). Bland-Altman plot found a mean difference of (QS-RGQ - CAP/CTM v2.0)=-0.63 log₁₀ IU/mL (95% limit of agreement, -1.48 to 0.22). Repeatability and total imprecision (% CV) of the QS-RGQ assay were 1.0% and 1.1% at 2,000 IU/mL, and 0.7% and 1.4% at 20,000 IU/mL, respectively. Linearity of this assay ranged from 31.6 to 1.0±10⁷ IU/mL, and the LOD was 2.95 IU/mL.
  
  
  CONCLUSIONS
  The artus HBV QS-RGQ assay showed good performance but significantly decreased detection rate and viral load compared with CAP/CTM v2.0 assays. This assay recommends using plasma; however, we used stored serum because of the retrospective study design. Usually HBV DNA quantification is performed in plasma or serum, but sample type and clinical relevance of quantitative values should be considered when determining the clinical application of this reagent.
authors.affiliation: Medical Clinic Laboratory Department of U2Bio Co. Ltd., Seoul, Korea.|Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Mi Soon
authors.initials: MS
authors.lastname: Han
authors.affiliation: Department of Laboratory Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea.
authors.forename: Yongjung
authors.initials: Y
authors.lastname: Park
authors.affiliation: Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Hyunjin
authors.initials: H
authors.lastname: Nah
authors.affiliation: Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea. kimhs54@yuhs.ac.
authors.forename: Hyon Suk
authors.initials: HS
authors.lastname: Kim
mesh_terms: D004279:DNA, Viral / Q000097:blood*; D006515:Hepatitis B virus / Q000235:genetics* / Q000302:isolation & purification; D019694:Hepatitis B, Chronic / Q000175:diagnosis* / Q000821:virology; D006801:Humans; D057230:Limit of Detection; D016133:Polymerase Chain Reaction; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D019562:Viral Load
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic
keywords: CAP/CTM v2.0 assay; HBV DNA quantification; Hepatitis B virus; Performance; artus HBV QS-RGQ assay