ArticleAnnals of laboratory medicine2017
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.
Article in Annals of laboratory medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed, 11 citations in OpenAlex.
- [Monitoring by high-sensitivity HBV DNA assay during treatment in chronic hepatitis B e antigen negative patients].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2018Trial
- Performance Evaluation of the Roche Cobas 5800 HBV and HCV Tests: Comparison of the 200 and 500 μL Protocols.Annals of laboratory medicine · 2024Article
- Performance evaluation of NeuMoDx 96 system for hepatitis B and C viral load.World journal of virology · 2023Article
- Performance Comparison of theBioMed research international · 2020Article
- Performance Evaluation of the Beckman Coulter DxN VERIS Hepatitis B Virus (HBV) Assay in Comparison With the Abbott RealTime HBV Assay.Annals of laboratory medicine · 2019Article
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Authors and funding
4 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHepatitis 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.
methodsA 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.
resultsDetection 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.
conclusionsThe 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.
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