Ann Lab Med.  2017 May;37(3):248-253. 10.3343/alm.2017.37.3.248.

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

• Han MS
• Park Y
• Nah H
• Kim HS

• KMID: 2369750
• DOI: http://doi.org/10.3343/alm.2017.37.3.248

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.

Keyword

Hepatitis B virus; HBV DNA quantification; artus HBV QS-RGQ assay; CAP/CTM v2.0 assay; Performance

MeSH Terms

DNA
DNA, Viral*
Hepatitis B virus
Hepatitis B, Chronic*
Hepatitis, Chronic*
Humans
Limit of Detection
Pathology, Molecular
Plasma
Retrospective Studies
Viral Load
DNA
DNA, Viral

Figure

• 

  Fig. 1 Comparison of Hepatitis B virus (HBV) DNA levels in clinical samples between CAP/CTM v2.0 and artus QS-RGQ assays (N=229). (A) The Passing-Bablok equation (95% CI of intercept: −0.52 to −0.27, slope: 0.92 to 0.0.96, r=0.91 to 0.95). (B) The mean difference (QS/RGQ-CAP/CTM) in Bland-Altman plot was −0.63±0.85 log10 IU/mL.

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