Quantitative detection of hepatitis B virus (HBV) DNA with the novel artus® HBV QS-RGQ Kit version 2

Fielder, H.; Javed, S.; Marques, C.; Wall, G.; Lange, C.; Tomlinson, D.

doi:10.1016/j.jcv.2015.07.199

Cited by 2 publications

(4 citation statements)

References 1 publication

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“…As studied before, there are several possible factors that may lead to assay discrepancies [10,20,21]. It has been reported that the HBV genotype B and low HBV viral load were 2 factors that contribute to significant differences in HBV DNA viral load detection, that is, ≥1/2 log 10 IU/mL, when compared to the real-time HBV assay (Abbott Laboratories, Abbott Park, IL, USA) with CAP/ CTM v2.0 assay [9].…”

Section: Discussionmentioning

confidence: 99%

Comparison of the Amplisure HBV Quantitative Kit with the Qiagen Artus HBV QS-RGQ Assay for Quantifying Viral DNA in Plasma Samples of Monitoring Cases

Ganesan¹,

Nikam²,

Ramana³

et al. 2021

Intervirology

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Background: Monitoring of hepatitis B virus (HBV) viral load has become an essential phase in the treatment of HBV. There are many commercial assays available for HBV viral load quantification. In this study, we have evaluated the performance characteristics of Amplisure® HBV Kit in comparison with the Qiagen artus HBV QS-RGQ kit for HBV DNA quantitation. Methods: Comparison of 2 methods was carried out on 200 clinical samples, 150 HBV DNA positive and 50 HBV DNA negative, by a reference method. Results obtained with Amplisure® HBV Kit (Amplisure HBV) were compared using the Qiagen artus HBV QS-RGQ assay results as the comparator method. Result: The overall performance of the Amplisure HBV compared with the comparator method shows positive and negative clinical agreement of 100 and 76%, respectively. Among the 12 qualitative discrepant samples, all positive with Amplisure HBV were sequenced and 10 were below comparator method’s LOD. For 5 weak positives (−0.22 to 0.98 log IU/mL), the sequencing failed. The 7 other positives (0.48 to 1.89 log IU/mL) were confirmed positive by sequencing. Quantitative comparison gave an r2 of 0.967 with a mean log difference of 0.09 log10 IU/mL. Conclusion: This study shows that Amplisure® HBV Quantitative Kit shows comparable performance with artus HBV QS-RGQ assays and can be useful in management and therapeutic monitoring of HBV in a clinical practice.

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Section: Discussionmentioning

confidence: 99%

Comparison of the Amplisure HBV Quantitative Kit with the Qiagen Artus HBV QS-RGQ Assay for Quantifying Viral DNA in Plasma Samples of Monitoring Cases

Ganesan¹,

Nikam²,

Ramana³

et al. 2021

Intervirology

View full text Add to dashboard Cite

show abstract

“…Newly launched artus QS-RGQ assay suggested a lower LOD, higher sample volume, and higher LOQ than CAP/CTM v2.0 assay by manufacturer. This new assay has not been researched enough about its performance, except for two abstracts with plasma samples [ 11 12 ]. Brichler et al [ 11 ] reported good correlation and agreement (r 2 =0.89, mean difference=0.1 log 10 IU/mL) between the new assay and CAP/CTM v2.0 assay.…”

Section: Discussionmentioning

confidence: 99%

“…However, 23% of the 230 samples showed more than ±0.5 log 10 IU/mL difference range, and the HBV DNA levels by the artus QS-RGQ assay were lower than the results by the CAP/CTM v2.0 assay in their study ( P value is not shown). Fielder et al [ 12 ] suggested that new assay showed detection capability of all eight genotypes, no cross-reactivity with 30 different pathogens and low LOD of 4.1 IU/mL.…”

Section: Discussionmentioning

confidence: 99%

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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

Han¹,

Park

Nah

et al. 2017

Ann Lab Med

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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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Quantitative detection of hepatitis B virus (HBV) DNA with the novel artus® HBV QS-RGQ Kit version 2

Cited by 2 publications

References 1 publication

Comparison of the Amplisure HBV Quantitative Kit with the Qiagen Artus HBV QS-RGQ Assay for Quantifying Viral DNA in Plasma Samples of Monitoring Cases

Comparison of the Amplisure HBV Quantitative Kit with the Qiagen Artus HBV QS-RGQ Assay for Quantifying Viral DNA in Plasma Samples of Monitoring Cases

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

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