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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

Authors
 Mi-Soon Han  ;  Yongjung Park  ;  Hyunjin Nah  ;  Hyon-Suk Kim 
Citation
 Annals of Laboratory Medicine, Vol.37(3) : 248-253, 2017 
Journal Title
 Annals of Laboratory Medicine 
ISSN
 2234-3806 
Issue Date
2017
MeSH
DNA, Viral/blood* ; Hepatitis B virus/genetics* ; Hepatitis B virus/isolation & purification ; Hepatitis B, Chronic/diagnosis* ; Hepatitis B, Chronic/virology ; Humans ; Limit of Detection ; Polymerase Chain Reaction ; Reagent Kits, Diagnostic ; Reproducibility of Results ; Viral Load
Keywords
CAP/CTM v2.0 assay ; HBV DNA quantification ; Hepatitis B virus ; Performance ; artus HBV QS-RGQ assay
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.
URI
http://ir.ymlib.yonsei.ac.kr/handle/22282913/161247
DOI
10.3343/alm.2017.37.3.248
Appears in Collections:
1. Journal Papers (연구논문) > 1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실)
Yonsei Authors
김현숙(Kim, Hyon Suk) ; 나현진(Nah, Hyunjin)
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