{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T00:37:44Z","timestamp":1792802264656,"version":"4.5.0"},"reference-count":30,"publisher":"Public Library of Science (PLoS)","issue":"2","license":[{"start":{"date-parts":[[2023,2,9]],"date-time":"2023-02-09T00:00:00Z","timestamp":1675900800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Fujifilm Wako Pure Chemical Corporation","id":[{"id":"https:\/\/ror.org\/01xjb6y46","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Fujifilm Wako Pure Chemical Corporation","id":[{"id":"https:\/\/ror.org\/01xjb6y46","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:p>\n                    Real-time monitoring of serum hepatitis B virus (HBV) levels is essential for the management of patients with chronic HBV infection in clinical practice, including monitoring the resistance of anti-HBV nucleotide analog or the detection of HBV reactivation. In this context, serum HBV deoxyribonucleic acid (DNA) quantification should be rapidly measured. A rapid HBV DNA quantification assay was established on the Fully Automated Genetic Analyzer, \u03bcTASWako g1. The assay performs automated sample preparation and DNA extraction, followed by the amplification and detection of quantitative polymerase chain reaction (PCR) combined with capillary electrophoresis (qPCR-CE) on integrated microfluidic chip. This study aimed to evaluate the analytical and clinical performance of HBV DNA assay on the \u03bcTASWako g1 platform in human serum and EDTA-plasma. The HBV DNA assay has a linear quantitative range from 20 to 10\n                    <jats:sup>8<\/jats:sup>\n                    IU\/mL of HBV DNA with standard deviation (SD) of \u22640.14 log\n                    <jats:sub>10<\/jats:sub>\n                    IU\/mL. The limits of detection of the assay were 4.18 for the serum and 4.35 for EDTA-plasma. The HBV assay demonstrated the equivalent performance in both human serum and EDTA-plasma matrices. The HBV genotypes A to H were detected with an accuracy of \u00b10.34 log\n                    <jats:sub>10<\/jats:sub>\n                    IU\/mL. In quantification range, the HBV DNA assay was correlated with Roche cobas AmpliPrep\/cobas TaqMan Ver2.0 (CAP\/CTM v2) (\n                    <jats:italic>r<\/jats:italic>\n                    = 0.964). The mean difference (\u03bcTASWako g1\u2013CAP\/CTM v2) of the reported HBV DNA was \u22120.01 log\n                    <jats:sub>10<\/jats:sub>\n                    IU\/mL. Overall, the sensitivity, accuracy, and precision of the \u03bcTASWako g1 HBV assay were comparable to the existing commercial HBV DNA assay, and the assay can be completed within 110 min. This evaluation suggests that the HBV DNA assay on the \u03bcTASWako g1 is potentially applied for alternative method of the HBV viral load test, in particular with the advantage of the HBV DNA result availability within 2 h, improving the HBV infection management.\n                  <\/jats:p>","DOI":"10.1371\/journal.pone.0278143","type":"journal-article","created":{"date-parts":[[2023,2,9]],"date-time":"2023-02-09T13:52:00Z","timestamp":1675950720000},"page":"e0278143","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":3,"title":["Rapid quantification assay of hepatitis B virus DNA in human serum and plasma by Fully Automated Genetic Analyzer \u03bcTASWako g1"],"prefix":"10.1371","volume":"18","author":[{"given":"Moto","family":"Watanabe","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1652-6168","authenticated-orcid":true,"given":"Hidenori","family":"Toyoda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5305-1392","authenticated-orcid":true,"given":"Tomohisa","family":"Kawabata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2023,2,9]]},"reference":[{"key":"pone.0278143.ref001","doi-asserted-by":"crossref","first-page":"104925","DOI":"10.1016\/j.antiviral.2020.104925","article-title":"Hepatitis B virus biology and life cycle","volume":"182","author":"S Tsukuda","year":"2020","journal-title":"Antiviral Res"},{"key":"pone.0278143.ref002","doi-asserted-by":"crossref","first-page":"353","DOI":"10.1016\/j.jceh.2012.10.003","article-title":"Molecular biology of the hepatitis B virus for clinicians","volume":"2","author":"S Datta","year":"2012","journal-title":"J Clin Exp Hepatol"},{"key":"pone.0278143.ref003","unstructured":"World Health Organization. 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Umemura","year":"2008","journal-title":"Clin Infect Dis"},{"key":"pone.0278143.ref010","doi-asserted-by":"crossref","first-page":"2013","DOI":"10.1093\/annonc\/mdp230","article-title":"Retrospective and prospective studies of hepatitis B virus reactivation in malignant lymphoma with occult HBV carrier","volume":"20","author":"N Fukushima","year":"2009","journal-title":"Ann Oncol"},{"key":"pone.0278143.ref011","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1007\/s12185-009-0359-5","article-title":"Reactivation of hepatitis B virus following systemic chemotherapy for malignant lymphoma","volume":"90","author":"S Kusumoto","year":"2009","journal-title":"Int J Hematol"},{"issue":"Suppl S1","key":"pone.0278143.ref012","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1111\/hepr.12269","article-title":"JSH Guidelines for the management of hepatitis B virus infection","volume":"44","author":"Drafting Committee for Hepatitis Management Guidelines and the Japan Society of Hepatology","year":"2014","journal-title":"Hepatol Res"},{"key":"pone.0278143.ref013","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1007\/s12072-015-9675-4","article-title":"Asian-Pacific clinical practice guidelines on the management of hepatitis B: a 2015 update","volume":"10","author":"SK Sarin","year":"2016","journal-title":"Hepatol Int"},{"key":"pone.0278143.ref014","doi-asserted-by":"crossref","first-page":"370","DOI":"10.1016\/j.jhep.2017.03.021","article-title":"EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection","volume":"67","author":"European Association for the Study of the Liver","year":"2017","journal-title":"J Hepatol"},{"key":"pone.0278143.ref015","doi-asserted-by":"crossref","first-page":"828","DOI":"10.1128\/JCM.00914-06","article-title":"COBAS AmpliPrep-COBAS TaqMan Hepatitis B Virus (HBV) Test: a Novel Automated Real-Time PCR Assay for Quantification of HBV DNA in Plasma","volume":"45","author":"T Allice","year":"2007","journal-title":"J Clin Microbiol"},{"key":"pone.0278143.ref016","doi-asserted-by":"crossref","first-page":"232","DOI":"10.1016\/j.jcv.2009.05.021","article-title":"Hepatitis B virus (HBV) genotype determination by the COBAS AmpliPrep\/COBAS TaqMan HBV Test, v2.0 in serum and plasma matrices","volume":"45","author":"S Goedel","year":"2009","journal-title":"J Clin Virol"},{"key":"pone.0278143.ref017","doi-asserted-by":"crossref","first-page":"7379","DOI":"10.1038\/s41598-020-64169-z","article-title":"Fully automated rapid quantification of Hepatitis C Virus RNA in human plasma and serum by integrated on-chip RT-qPCR and capillary electrophoresis","volume":"10","author":"SDH Chan","year":"2020","journal-title":"Sci Rep"},{"key":"pone.0278143.ref018","doi-asserted-by":"crossref","first-page":"545","DOI":"10.1002\/elps.201500298","article-title":"On-chip quantitative PCR using integrated real-time detection by capillary electrophoresis","volume":"37","author":"Y Liu","year":"2016","journal-title":"Electrophoresis"},{"key":"pone.0278143.ref019","doi-asserted-by":"crossref","first-page":"3641","DOI":"10.1128\/JCM.01306-10","article-title":"Performance of version 2.0 of the Cobas AmpliPrep\/Cobas TaqMan real-time PCR assay for hepatitis B virus DNA quantification","volume":"48","author":"S Chevaliez","year":"2010","journal-title":"J Clin Microbiol"},{"key":"pone.0278143.ref020","doi-asserted-by":"crossref","first-page":"1211","DOI":"10.1128\/JCM.02219-16","article-title":"The New Aptima HBV Quant Real-Time TMA Assay Accurately Quantifies Hepatitis B Virus DNA from Genotypes A to F","volume":"55","author":"S Chevaliez","year":"2017","journal-title":"J Clin Microbiol"},{"key":"pone.0278143.ref021","doi-asserted-by":"crossref","first-page":"83","DOI":"10.1016\/j.jcv.2018.05.007","article-title":"Analytical performance of the Hologic Aptima HBV Quant Assay and the COBAS Ampliprep\/COBAS TaqMan HBV test v2.0 for the quantification of HBV DNA in plasma samples","volume":"104","author":"K Sch\u00f8nning","year":"2018","journal-title":"J Clin Virol"},{"key":"pone.0278143.ref022","doi-asserted-by":"crossref","first-page":"206","DOI":"10.1016\/j.jcv.2014.04.008","article-title":"Comparison of the Abbott RealTime HBV assay with the Roche Cobas AmpliPrep\/Cobas TaqMan HBV assay for HBV DNA detection and quantification","volume":"60","author":"ML Yeh","year":"2014","journal-title":"J Clin Virol"},{"key":"pone.0278143.ref023","doi-asserted-by":"crossref","first-page":"94","DOI":"10.1186\/s12985-017-0759-8","article-title":"Real-time PCR assays for hepatitis B virus DNA quantification may require two different targets","volume":"14","author":"C Liu","year":"2017","journal-title":"Virol J"},{"issue":"3\u20134","key":"pone.0278143.ref024","doi-asserted-by":"crossref","first-page":"141","DOI":"10.1159\/000360947","article-title":"Genotypes and genetic variability of hepatitis B virus","volume":"57","author":"A Kramvis","year":"2014","journal-title":"Intervirology"},{"key":"pone.0278143.ref025","doi-asserted-by":"crossref","first-page":"271","DOI":"10.1099\/jgv.0.001387","article-title":"Analysis of genomic-length HBV sequences to determine genotype and subgenotype reference sequences","volume":"101","author":"AL McNaughton","year":"2020","journal-title":"J Gen Virol"},{"key":"pone.0278143.ref026","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1002\/jmv.20319","article-title":"Characterization of seven genotypes (A to E, G and H) of hepatitis B virus recovered from Japanese patients infected with human immunodeficiency virus type 1","volume":"76","author":"T Shibayama","year":"2005","journal-title":"J Med Virol"},{"key":"pone.0278143.ref027","first-page":"714","article-title":"Mutation in HBV RNA-dependent DNA polymerase confers resistance to lamivudine in vivo","volume":"24","author":"GA Tipples","year":"1996","journal-title":"Hepatology"},{"key":"pone.0278143.ref028","doi-asserted-by":"crossref","first-page":"2587","DOI":"10.1128\/JCM.00265-06","article-title":"Lamivudine Resistance of Hepatitis B Virus Masked by Coemergence of Mutations in Probe Region of the COBAS AMPLICOR Assay","volume":"44","author":"M Lindh","year":"2006","journal-title":"J Clin Microbiol"},{"key":"pone.0278143.ref029","doi-asserted-by":"crossref","first-page":"264","DOI":"10.1203\/00006450-199209000-00002","article-title":"Mutations within the S gene of hepatitis B virus transmitted from mothers to babies immunized with hepatitis B immune globulin and vaccine","volume":"32","author":"H Okamoto","year":"1992","journal-title":"Pediatr Res"},{"key":"pone.0278143.ref030","doi-asserted-by":"crossref","first-page":"2671","DOI":"10.1128\/jvi.68.4.2671-2676.1994","article-title":"Naturally occurring escape mutants of hepatitis B virus with various mutations in the S gene in carriers seropositive for 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