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Article: Clinical evaluation of the Digene Hybrid Capture II test and the COBAS AMPLICOR Monitor test for determination of hepatitis B virus DNA levels

TitleClinical evaluation of the Digene Hybrid Capture II test and the COBAS AMPLICOR Monitor test for determination of hepatitis B virus DNA levels
Authors
Issue Date2004
PublisherAmerican Society for Microbiology.
Citation
Journal Of Clinical Microbiology, 2004, v. 42 n. 8, p. 3513-3517 How to Cite?
AbstractThe measurement of hepatitis B virus (HBV) DNA is important for the assessment of liver disease and treatment efficacy. Most commercially available assays for the determination of HBV DNA levels have limited linear ranges. This study was performed to evaluate the clinical performance of the Digene Hybrid Capture II (Digene HC II assay) and the COBAS AMPLICOR Monitor test (COBAS-AM assay), with special emphasis on anti-HBV e antigen (HBeAg)-positive patients with low HBV DNA levels. A total of 425 Chinese patients with chronic hepatitis B were recruited. A total of 107 patients were HBeAg positive, and 318 patients were HBeAg negative. The Digene HC II assay and the COBAS-AM assay had similar intra-assay and interassay variabilities. A total of 264 patients (62.1%) had HBV DNA levels undetectable by the Digene HC II assay, and 47 patients (11.1%) had HBV DNA levels undetectable by the COBAS-AM assay (P < 0.001). For the 161 patients with HBV DNA levels detectable by the Digene HC II assay, the HBV DNA levels obtained by the Digene HC II assay and by the COBAS-AM assay showed an excellent correlation (r = 0.95; P < 0.001). The linear ranges of the Digene HC II assay and the COBAS-AM assay marginally overlapped. Before HBV DNA levels could be determined by the COBAS-AM assay, predilution had to be performed for 158 of 161 patients (98.1%) with HBV DNA levels detectable by the Digene HC II assay and for 10 of 264 patients (3.8%) with HBV DNA levels undetectable by the Digene HC II assay. The cost for assaying each serum sample by using different strategies was calculated. The COBAS-AM assay was more sensitive than the Digene HC II assay and more suitable for monitoring low levels of HBV viremia.
Persistent Identifierhttp://hdl.handle.net/10722/49137
ISSN
2015 Impact Factor: 3.631
2015 SCImago Journal Rankings: 2.151
PubMed Central ID
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorYuan, HJen_HK
dc.contributor.authorYuen, MFen_HK
dc.contributor.authorWong, DKHen_HK
dc.contributor.authorSum, SSMen_HK
dc.contributor.authorLai, CLen_HK
dc.date.accessioned2008-06-12T06:35:13Z-
dc.date.available2008-06-12T06:35:13Z-
dc.date.issued2004en_HK
dc.identifier.citationJournal Of Clinical Microbiology, 2004, v. 42 n. 8, p. 3513-3517en_HK
dc.identifier.issn0095-1137en_HK
dc.identifier.urihttp://hdl.handle.net/10722/49137-
dc.description.abstractThe measurement of hepatitis B virus (HBV) DNA is important for the assessment of liver disease and treatment efficacy. Most commercially available assays for the determination of HBV DNA levels have limited linear ranges. This study was performed to evaluate the clinical performance of the Digene Hybrid Capture II (Digene HC II assay) and the COBAS AMPLICOR Monitor test (COBAS-AM assay), with special emphasis on anti-HBV e antigen (HBeAg)-positive patients with low HBV DNA levels. A total of 425 Chinese patients with chronic hepatitis B were recruited. A total of 107 patients were HBeAg positive, and 318 patients were HBeAg negative. The Digene HC II assay and the COBAS-AM assay had similar intra-assay and interassay variabilities. A total of 264 patients (62.1%) had HBV DNA levels undetectable by the Digene HC II assay, and 47 patients (11.1%) had HBV DNA levels undetectable by the COBAS-AM assay (P < 0.001). For the 161 patients with HBV DNA levels detectable by the Digene HC II assay, the HBV DNA levels obtained by the Digene HC II assay and by the COBAS-AM assay showed an excellent correlation (r = 0.95; P < 0.001). The linear ranges of the Digene HC II assay and the COBAS-AM assay marginally overlapped. Before HBV DNA levels could be determined by the COBAS-AM assay, predilution had to be performed for 158 of 161 patients (98.1%) with HBV DNA levels detectable by the Digene HC II assay and for 10 of 264 patients (3.8%) with HBV DNA levels undetectable by the Digene HC II assay. The cost for assaying each serum sample by using different strategies was calculated. The COBAS-AM assay was more sensitive than the Digene HC II assay and more suitable for monitoring low levels of HBV viremia.en_HK
dc.format.extent392 bytes-
dc.format.mimetypetext/html-
dc.languageengen_HK
dc.publisherAmerican Society for Microbiology.en_HK
dc.relation.ispartofJournal of Clinical Microbiologyen_HK
dc.rightsJournal of Clinical Microbiology. Copyright © American Society for Microbiology.en_HK
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License-
dc.rightsCopyright © American Society for Microbiology, Journal of Clinical Microbiology, 2004, v. 42 n. 8, p. 3513-3517en_HK
dc.subject.meshDNA, Viral - blooden_HK
dc.subject.meshHepatitis B virus - genetics - isolation & purificationen_HK
dc.subject.meshHepatitis B, Chronic - diagnosisen_HK
dc.subject.meshPolymerase Chain Reaction - methodsen_HK
dc.subject.meshReproducibility of Resultsen_HK
dc.titleClinical evaluation of the Digene Hybrid Capture II test and the COBAS AMPLICOR Monitor test for determination of hepatitis B virus DNA levelsen_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0095-1137&volume=42&issue=8&spage=3513&epage=3517&date=2004&atitle=Clinical+evaluation+of+the+Digene+Hybrid+Capture+II+test+and+the+COBAS+AMPLICOR+monitor+test+for+determination+of+hepatitis+B+virus+DNA+levelsen_HK
dc.identifier.emailYuen, MF:mfyuen@hkucc.hku.hken_HK
dc.identifier.emailWong, DKH:danywong@hku.hken_HK
dc.identifier.emailLai, CL:hrmelcl@hku.hken_HK
dc.identifier.authorityYuen, MF=rp00479en_HK
dc.identifier.authorityWong, DKH=rp00492en_HK
dc.identifier.authorityLai, CL=rp00314en_HK
dc.description.naturepublished_or_final_versionen_HK
dc.identifier.doi10.1128/JCM.42.8.3513-3517.2004en_HK
dc.identifier.pmid15297491-
dc.identifier.pmcidPMC497578en_HK
dc.identifier.scopuseid_2-s2.0-3843113416en_HK
dc.identifier.hkuros97710-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-3843113416&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume42en_HK
dc.identifier.issue8en_HK
dc.identifier.spage3513en_HK
dc.identifier.epage3517en_HK
dc.identifier.isiWOS:000223286500020-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridYuan, HJ=7402446707en_HK
dc.identifier.scopusauthoridYuen, MF=7102031955en_HK
dc.identifier.scopusauthoridWong, DKH=7401535819en_HK
dc.identifier.scopusauthoridSum, SSM=6603889128en_HK
dc.identifier.scopusauthoridLai, CL=7403086396en_HK

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