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학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
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연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2017.1
- 수록면
- 248 - 253 (6page)
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초록· 키워드
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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.
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참고문헌 (21)
참고문헌 신청
Alestig E / 2001 / Phylogenetic origin of hepatitis B virus strains with precore C-1858 variant / J Clin Microbiol 39 : 3200 ~ 3203
Alexopoulou A / 2014 / HBeAg negative variants and their role in the natural history of chronic hepatitis B virus infection / World J Gastroenterol 20 : 7644 ~ 7652
Allice T / 2007 / COBAS AmpliPrep-COBAS TaqMan hepatitis B virus (HBV) test: a novel automated real-time PCR assay for quantification of HBV DNA in plasma / J Clin Microbiol
Brichler S / 2015 / P0543: Comparative evaluation of the artus HBV QS-RGQ assay and the roche cobas mpliprep/cobas taqman V.2 HBV test for the quantification of HBV DNA in p
Caliendo AM / 2011 / Multilaboratory evaluation of real-time PCR tests for hepatitis B virus DNA quantification / J Clin Microbiol 49 : 2854 ~ 2858
Alexopoulou A / 2014 / HBeAg negative variants and their role in the natural history of chronic hepatitis B virus infection / World J Gastroenterol 20 : 7644 ~ 7652
Allice T / 2007 / COBAS AmpliPrep-COBAS TaqMan hepatitis B virus (HBV) test: a novel automated real-time PCR assay for quantification of HBV DNA in plasma / J Clin Microbiol
Brichler S / 2015 / P0543: Comparative evaluation of the artus HBV QS-RGQ assay and the roche cobas mpliprep/cobas taqman V.2 HBV test for the quantification of HBV DNA in p
Caliendo AM / 2011 / Multilaboratory evaluation of real-time PCR tests for hepatitis B virus DNA quantification / J Clin Microbiol 49 : 2854 ~ 2858
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