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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

DC FieldValueLanguage
dc.contributor.author김현숙-
dc.contributor.author나현진-
dc.date.accessioned2018-07-20T08:30:07Z-
dc.date.available2018-07-20T08:30:07Z-
dc.date.issued2017-
dc.identifier.issn2234-3806-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/161247-
dc.description.abstractBACKGROUND: 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.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherKorean Society for Laboratory Medicine-
dc.relation.isPartOfAnnals of Laboratory Medicine-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHDNA, Viral/blood*-
dc.subject.MESHHepatitis B virus/genetics*-
dc.subject.MESHHepatitis B virus/isolation & purification-
dc.subject.MESHHepatitis B, Chronic/diagnosis*-
dc.subject.MESHHepatitis B, Chronic/virology-
dc.subject.MESHHumans-
dc.subject.MESHLimit of Detection-
dc.subject.MESHPolymerase Chain Reaction-
dc.subject.MESHReagent Kits, Diagnostic-
dc.subject.MESHReproducibility of Results-
dc.subject.MESHViral Load-
dc.titleComparison 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-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Laboratory Medicine-
dc.contributor.googleauthorMi-Soon Han-
dc.contributor.googleauthorYongjung Park-
dc.contributor.googleauthorHyunjin Nah-
dc.contributor.googleauthorHyon-Suk Kim-
dc.identifier.doi10.3343/alm.2017.37.3.248-
dc.contributor.localIdA01117-
dc.contributor.localIdA04555-
dc.relation.journalcodeJ00164-
dc.identifier.eissn2234-3814-
dc.identifier.pmid28224771-
dc.subject.keywordCAP/CTM v2.0 assay-
dc.subject.keywordHBV DNA quantification-
dc.subject.keywordHepatitis B virus-
dc.subject.keywordPerformance-
dc.subject.keywordartus HBV QS-RGQ assay-
dc.contributor.alternativeNameKim, Hyon Suk-
dc.contributor.alternativeNameNah, Hyunjin-
dc.contributor.affiliatedAuthorKim, Hyon Suk-
dc.contributor.affiliatedAuthorNah, Hyunjin-
dc.citation.volume37-
dc.citation.number3-
dc.citation.startPage248-
dc.citation.endPage253-
dc.identifier.bibliographicCitationAnnals of Laboratory Medicine, Vol.37(3) : 248-253, 2017-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실) > 1. Journal Papers

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