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Expertise of Laboratories in Viral Load Quantification, Genotyping, and Precore Mutant Determination for Hepatitis B Virus in a Multicenter Study
A national evaluation study was performed in 14 specialized laboratories with the objective of assessing their capacities to provide (i) hepatitis B virus (HBV) viral loads (VL), (ii) HBV genotypes, and(iii) identification of precore/core mutants. The panel consisted of 12 HBV DNA-positive samples w...
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| Published in: | Journal of Clinical Microbiology 2006-10, Vol.44 (10), p.3600-3607 |
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| creator | Laperche, Syria Thibault, Vincent Bouchardeau, Françoise Alain, Sophie Castelain, Sandrine Gassin, Michelle Gueudin, Marie Halfon, Philippe Larrat, Sylvie Lunel, Françoise Martinot-Peignoux, Michèle Mercier, Bernard Pawlotsky, Jean-Michel Pozzetto, Bruno Roque-Afonso, Anne-Marie Roudot-Thoraval, Françoise Sauné, Karine Lefrère, Jean-Jacques |
| description | A national evaluation study was performed in 14 specialized laboratories with the objective of assessing their capacities to provide (i) hepatitis B virus (HBV) viral loads (VL), (ii) HBV genotypes, and(iii) identification of precore/core mutants. The panel consisted of 12 HBV DNA-positive samples with VLs from 2.8 to 9.1 log10 copies/ml, different HBV genotypes (A to F), and 3 mutant and 9 wild-type samples at nucleotide 1896. The coefficients of variation of the mean VLs ranged from 2.4% to 10.4% with the Cobas HBV Monitor assay, from 1.8% to 5.5% with the Cobas TaqMan 48, from 1.5 to 26.2% with RealArt HBV PCR, and from 0 to 7% with branched DNA (bDNA). The Cobas Monitor assay underestimated the VLs of genotype F samples, with differences ranging from 1.4 to 2.4 log10 copies/ml. The accuracies of genotype determinations ranged from 33% to 100%, and those of precore mutant determinations ranged from 25 to 100%. This study showed some drawbacks of two widely used assays: (i) Cobas Monitor has a narrow dynamic range and underestimates genotype F sample VLs and (ii) bDNA shows poor sensitivity and may fail to identify patients with low VLs. With higher performance in terms of analytical sensitivity combined with a larger dynamic range and an ability to quantify the main genotypes equally, real-time PCR methods appear more appropriate for accurate monitoring of HBV DNA quantification. Furthermore, the clinical implications of HBV genotyping and the determination of precore/core mutants need to be clearly stated to justify the standardization of these methods. |
| doi_str_mv | 10.1128/jcm.00732-06 |
| format | article |
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The panel consisted of 12 HBV DNA-positive samples with VLs from 2.8 to 9.1 log10 copies/ml, different HBV genotypes (A to F), and 3 mutant and 9 wild-type samples at nucleotide 1896. The coefficients of variation of the mean VLs ranged from 2.4% to 10.4% with the Cobas HBV Monitor assay, from 1.8% to 5.5% with the Cobas TaqMan 48, from 1.5 to 26.2% with RealArt HBV PCR, and from 0 to 7% with branched DNA (bDNA). The Cobas Monitor assay underestimated the VLs of genotype F samples, with differences ranging from 1.4 to 2.4 log10 copies/ml. The accuracies of genotype determinations ranged from 33% to 100%, and those of precore mutant determinations ranged from 25 to 100%. This study showed some drawbacks of two widely used assays: (i) Cobas Monitor has a narrow dynamic range and underestimates genotype F sample VLs and (ii) bDNA shows poor sensitivity and may fail to identify patients with low VLs. With higher performance in terms of analytical sensitivity combined with a larger dynamic range and an ability to quantify the main genotypes equally, real-time PCR methods appear more appropriate for accurate monitoring of HBV DNA quantification. Furthermore, the clinical implications of HBV genotyping and the determination of precore/core mutants need to be clearly stated to justify the standardization of these methods.</description><identifier>ISSN: 0095-1137</identifier><identifier>EISSN: 1098-660X</identifier><identifier>EISSN: 1098-5530</identifier><identifier>DOI: 10.1128/jcm.00732-06</identifier><identifier>PMID: 17021089</identifier><identifier>CODEN: JCMIDW</identifier><language>eng</language><publisher>Washington, DC: American Society for Microbiology</publisher><subject>Bacteriology ; Biological and medical sciences ; France ; Fundamental and applied biological sciences. Psychology ; Genotype ; Hepatitis B ; Hepatitis B - virology ; Hepatitis B virus ; Hepatitis B virus - genetics ; Hepatitis B virus - isolation & purification ; Human health and pathology ; Humans ; Infectious diseases ; Laboratories ; Laboratories - standards ; Life Sciences ; Medical sciences ; Microbiology ; Microbiology and Parasitology ; Miscellaneous ; Multicenter Studies as Topic ; Multicenter Studies as Topic - standards ; Mutation ; Viral Core Proteins ; Viral Core Proteins - genetics ; Viral Load ; Virology</subject><ispartof>Journal of Clinical Microbiology, 2006-10, Vol.44 (10), p.3600-3607</ispartof><rights>2006 INIST-CNRS</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><rights>Copyright © 2006, American Society for Microbiology 2006</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c594t-a0582b5cd258516f2d6a7cb9fd7eef7ef88cc6131d3663b81995d2da0faf8f0b3</citedby><cites>FETCH-LOGICAL-c594t-a0582b5cd258516f2d6a7cb9fd7eef7ef88cc6131d3663b81995d2da0faf8f0b3</cites><orcidid>0000-0002-2603-8467 ; 0000-0001-6517-2901 ; 0000-0003-0745-7559 ; 0000-0002-2670-3148</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC1594785/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC1594785/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,315,733,786,790,891,3207,3208,27957,27958,53827,53829</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=18184453$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/17021089$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://unilim.hal.science/hal-00406609$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Laperche, Syria</creatorcontrib><creatorcontrib>Thibault, Vincent</creatorcontrib><creatorcontrib>Bouchardeau, Françoise</creatorcontrib><creatorcontrib>Alain, Sophie</creatorcontrib><creatorcontrib>Castelain, Sandrine</creatorcontrib><creatorcontrib>Gassin, Michelle</creatorcontrib><creatorcontrib>Gueudin, Marie</creatorcontrib><creatorcontrib>Halfon, Philippe</creatorcontrib><creatorcontrib>Larrat, Sylvie</creatorcontrib><creatorcontrib>Lunel, Françoise</creatorcontrib><creatorcontrib>Martinot-Peignoux, Michèle</creatorcontrib><creatorcontrib>Mercier, Bernard</creatorcontrib><creatorcontrib>Pawlotsky, Jean-Michel</creatorcontrib><creatorcontrib>Pozzetto, Bruno</creatorcontrib><creatorcontrib>Roque-Afonso, Anne-Marie</creatorcontrib><creatorcontrib>Roudot-Thoraval, Françoise</creatorcontrib><creatorcontrib>Sauné, Karine</creatorcontrib><creatorcontrib>Lefrère, Jean-Jacques</creatorcontrib><title>Expertise of Laboratories in Viral Load Quantification, Genotyping, and Precore Mutant Determination for Hepatitis B Virus in a Multicenter Study</title><title>Journal of Clinical Microbiology</title><addtitle>J Clin Microbiol</addtitle><description>A national evaluation study was performed in 14 specialized laboratories with the objective of assessing their capacities to provide (i) hepatitis B virus (HBV) viral loads (VL), (ii) HBV genotypes, and(iii) identification of precore/core mutants. The panel consisted of 12 HBV DNA-positive samples with VLs from 2.8 to 9.1 log10 copies/ml, different HBV genotypes (A to F), and 3 mutant and 9 wild-type samples at nucleotide 1896. The coefficients of variation of the mean VLs ranged from 2.4% to 10.4% with the Cobas HBV Monitor assay, from 1.8% to 5.5% with the Cobas TaqMan 48, from 1.5 to 26.2% with RealArt HBV PCR, and from 0 to 7% with branched DNA (bDNA). The Cobas Monitor assay underestimated the VLs of genotype F samples, with differences ranging from 1.4 to 2.4 log10 copies/ml. The accuracies of genotype determinations ranged from 33% to 100%, and those of precore mutant determinations ranged from 25 to 100%. This study showed some drawbacks of two widely used assays: (i) Cobas Monitor has a narrow dynamic range and underestimates genotype F sample VLs and (ii) bDNA shows poor sensitivity and may fail to identify patients with low VLs. With higher performance in terms of analytical sensitivity combined with a larger dynamic range and an ability to quantify the main genotypes equally, real-time PCR methods appear more appropriate for accurate monitoring of HBV DNA quantification. Furthermore, the clinical implications of HBV genotyping and the determination of precore/core mutants need to be clearly stated to justify the standardization of these methods.</description><subject>Bacteriology</subject><subject>Biological and medical sciences</subject><subject>France</subject><subject>Fundamental and applied biological sciences. Psychology</subject><subject>Genotype</subject><subject>Hepatitis B</subject><subject>Hepatitis B - virology</subject><subject>Hepatitis B virus</subject><subject>Hepatitis B virus - genetics</subject><subject>Hepatitis B virus - isolation & purification</subject><subject>Human health and pathology</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Laboratories</subject><subject>Laboratories - standards</subject><subject>Life Sciences</subject><subject>Medical sciences</subject><subject>Microbiology</subject><subject>Microbiology and Parasitology</subject><subject>Miscellaneous</subject><subject>Multicenter Studies as Topic</subject><subject>Multicenter Studies as Topic - standards</subject><subject>Mutation</subject><subject>Viral Core Proteins</subject><subject>Viral Core Proteins - genetics</subject><subject>Viral Load</subject><subject>Virology</subject><issn>0095-1137</issn><issn>1098-660X</issn><issn>1098-5530</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2006</creationdate><recordtype>article</recordtype><recordid>eNqFkl1vFCEYhSdGY9fqnddKmmhislNfhoGBG5O61q5mGzW1xjvCMLClmRlWmKnuz_Afy37EqjdeEeDhnPeEk2WPMRxjXPCX17o7BqhIkQO7k00wCJ4zBl_vZhMAQXOMSXWQPYjxGgCXJaX3swNcQYGBi0n28_THyoTBRYO8RQtV-6AGH5yJyPXoiwuqRQuvGvRpVP3grNNqcL6fojPT-2G9cv1yilTfoI_BaB8MOh-HBKI3ZjChc_2WRtYHNDertElO6PVGd9waqMS3g9OmTzi6GMZm_TC7Z1UbzaP9ephdvj39PJvniw9n72Yni1xTUQ65AsqLmuqmoJxiZouGqUrXwjaVMbYylnOtGSa4IYyRmmMhaFM0Cqyy3EJNDrNXO93VWHem2YyQwspVcJ0Ka-mVk3_f9O5KLv2NxMm_4jQJvNgJXP3zbH6ykJszgBLST4gbnNjne7Pgv40mDrJzUZu2Vb3xY5SMi4IyXv4XxIIwykEkcLoDdfAxBmN_j4BBbooh38_O5bYYEljCn_yZ9hbeNyEBz_aAilq1Nqheu3jLccxTeUjijvap3fLquwtGqtjJVEJZlhtrwgAS9HQHWeWlWoYkdHlRACaAMTBcMvILZ6nXxg</recordid><startdate>20061001</startdate><enddate>20061001</enddate><creator>Laperche, Syria</creator><creator>Thibault, Vincent</creator><creator>Bouchardeau, Françoise</creator><creator>Alain, Sophie</creator><creator>Castelain, Sandrine</creator><creator>Gassin, Michelle</creator><creator>Gueudin, Marie</creator><creator>Halfon, Philippe</creator><creator>Larrat, Sylvie</creator><creator>Lunel, Françoise</creator><creator>Martinot-Peignoux, Michèle</creator><creator>Mercier, Bernard</creator><creator>Pawlotsky, Jean-Michel</creator><creator>Pozzetto, Bruno</creator><creator>Roque-Afonso, Anne-Marie</creator><creator>Roudot-Thoraval, Françoise</creator><creator>Sauné, Karine</creator><creator>Lefrère, Jean-Jacques</creator><general>American Society for Microbiology</general><scope>FBQ</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7U9</scope><scope>H94</scope><scope>7X8</scope><scope>1XC</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-2603-8467</orcidid><orcidid>https://orcid.org/0000-0001-6517-2901</orcidid><orcidid>https://orcid.org/0000-0003-0745-7559</orcidid><orcidid>https://orcid.org/0000-0002-2670-3148</orcidid></search><sort><creationdate>20061001</creationdate><title>Expertise of Laboratories in Viral Load Quantification, Genotyping, and Precore Mutant Determination for Hepatitis B Virus in a Multicenter Study</title><author>Laperche, Syria ; Thibault, Vincent ; Bouchardeau, Françoise ; Alain, Sophie ; Castelain, Sandrine ; Gassin, Michelle ; Gueudin, Marie ; Halfon, Philippe ; Larrat, Sylvie ; Lunel, Françoise ; Martinot-Peignoux, Michèle ; Mercier, Bernard ; Pawlotsky, Jean-Michel ; Pozzetto, Bruno ; Roque-Afonso, Anne-Marie ; Roudot-Thoraval, Françoise ; Sauné, Karine ; Lefrère, Jean-Jacques</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c594t-a0582b5cd258516f2d6a7cb9fd7eef7ef88cc6131d3663b81995d2da0faf8f0b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2006</creationdate><topic>Bacteriology</topic><topic>Biological and medical sciences</topic><topic>France</topic><topic>Fundamental and applied biological sciences. Psychology</topic><topic>Genotype</topic><topic>Hepatitis B</topic><topic>Hepatitis B - virology</topic><topic>Hepatitis B virus</topic><topic>Hepatitis B virus - genetics</topic><topic>Hepatitis B virus - isolation & purification</topic><topic>Human health and pathology</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Laboratories</topic><topic>Laboratories - standards</topic><topic>Life Sciences</topic><topic>Medical sciences</topic><topic>Microbiology</topic><topic>Microbiology and Parasitology</topic><topic>Miscellaneous</topic><topic>Multicenter Studies as Topic</topic><topic>Multicenter Studies as Topic - standards</topic><topic>Mutation</topic><topic>Viral Core Proteins</topic><topic>Viral Core Proteins - genetics</topic><topic>Viral Load</topic><topic>Virology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Laperche, Syria</creatorcontrib><creatorcontrib>Thibault, Vincent</creatorcontrib><creatorcontrib>Bouchardeau, Françoise</creatorcontrib><creatorcontrib>Alain, Sophie</creatorcontrib><creatorcontrib>Castelain, Sandrine</creatorcontrib><creatorcontrib>Gassin, Michelle</creatorcontrib><creatorcontrib>Gueudin, Marie</creatorcontrib><creatorcontrib>Halfon, Philippe</creatorcontrib><creatorcontrib>Larrat, Sylvie</creatorcontrib><creatorcontrib>Lunel, Françoise</creatorcontrib><creatorcontrib>Martinot-Peignoux, Michèle</creatorcontrib><creatorcontrib>Mercier, Bernard</creatorcontrib><creatorcontrib>Pawlotsky, Jean-Michel</creatorcontrib><creatorcontrib>Pozzetto, Bruno</creatorcontrib><creatorcontrib>Roque-Afonso, Anne-Marie</creatorcontrib><creatorcontrib>Roudot-Thoraval, Françoise</creatorcontrib><creatorcontrib>Sauné, Karine</creatorcontrib><creatorcontrib>Lefrère, Jean-Jacques</creatorcontrib><collection>AGRIS</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><collection>Hyper Article en Ligne (HAL)</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of Clinical Microbiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Laperche, Syria</au><au>Thibault, Vincent</au><au>Bouchardeau, Françoise</au><au>Alain, Sophie</au><au>Castelain, Sandrine</au><au>Gassin, Michelle</au><au>Gueudin, Marie</au><au>Halfon, Philippe</au><au>Larrat, Sylvie</au><au>Lunel, Françoise</au><au>Martinot-Peignoux, Michèle</au><au>Mercier, Bernard</au><au>Pawlotsky, Jean-Michel</au><au>Pozzetto, Bruno</au><au>Roque-Afonso, Anne-Marie</au><au>Roudot-Thoraval, Françoise</au><au>Sauné, Karine</au><au>Lefrère, Jean-Jacques</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Expertise of Laboratories in Viral Load Quantification, Genotyping, and Precore Mutant Determination for Hepatitis B Virus in a Multicenter Study</atitle><jtitle>Journal of Clinical Microbiology</jtitle><addtitle>J Clin Microbiol</addtitle><date>2006-10-01</date><risdate>2006</risdate><volume>44</volume><issue>10</issue><spage>3600</spage><epage>3607</epage><pages>3600-3607</pages><issn>0095-1137</issn><eissn>1098-660X</eissn><eissn>1098-5530</eissn><coden>JCMIDW</coden><notes>ObjectType-Article-1</notes><notes>SourceType-Scholarly Journals-1</notes><notes>ObjectType-Feature-2</notes><notes>content type line 23</notes><notes>PMCID: PMC1594785</notes><notes>Corresponding author. Mailing address: Centre National de Référence pour les Hépatites B et C en Transfusion, Département des Agents Transmissibles par le Sang, Institut National de la Transfusion Sanguine, Paris, France. Phone: (33) 1 44 49 30 52. Fax: 1 44 49 30 59. E-mail: slaperche@ints.fr.</notes><abstract>A national evaluation study was performed in 14 specialized laboratories with the objective of assessing their capacities to provide (i) hepatitis B virus (HBV) viral loads (VL), (ii) HBV genotypes, and(iii) identification of precore/core mutants. The panel consisted of 12 HBV DNA-positive samples with VLs from 2.8 to 9.1 log10 copies/ml, different HBV genotypes (A to F), and 3 mutant and 9 wild-type samples at nucleotide 1896. The coefficients of variation of the mean VLs ranged from 2.4% to 10.4% with the Cobas HBV Monitor assay, from 1.8% to 5.5% with the Cobas TaqMan 48, from 1.5 to 26.2% with RealArt HBV PCR, and from 0 to 7% with branched DNA (bDNA). The Cobas Monitor assay underestimated the VLs of genotype F samples, with differences ranging from 1.4 to 2.4 log10 copies/ml. The accuracies of genotype determinations ranged from 33% to 100%, and those of precore mutant determinations ranged from 25 to 100%. This study showed some drawbacks of two widely used assays: (i) Cobas Monitor has a narrow dynamic range and underestimates genotype F sample VLs and (ii) bDNA shows poor sensitivity and may fail to identify patients with low VLs. With higher performance in terms of analytical sensitivity combined with a larger dynamic range and an ability to quantify the main genotypes equally, real-time PCR methods appear more appropriate for accurate monitoring of HBV DNA quantification. Furthermore, the clinical implications of HBV genotyping and the determination of precore/core mutants need to be clearly stated to justify the standardization of these methods.</abstract><cop>Washington, DC</cop><pub>American Society for Microbiology</pub><pmid>17021089</pmid><doi>10.1128/jcm.00732-06</doi><tpages>8</tpages><orcidid>https://orcid.org/0000-0002-2603-8467</orcidid><orcidid>https://orcid.org/0000-0001-6517-2901</orcidid><orcidid>https://orcid.org/0000-0003-0745-7559</orcidid><orcidid>https://orcid.org/0000-0002-2670-3148</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of Clinical Microbiology, 2006-10, Vol.44 (10), p.3600-3607 |
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| language | eng |
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| source | Open Access: PubMed Central; American Society for Microbiology Journals |
| subjects | Bacteriology Biological and medical sciences France Fundamental and applied biological sciences. Psychology Genotype Hepatitis B Hepatitis B - virology Hepatitis B virus Hepatitis B virus - genetics Hepatitis B virus - isolation & purification Human health and pathology Humans Infectious diseases Laboratories Laboratories - standards Life Sciences Medical sciences Microbiology Microbiology and Parasitology Miscellaneous Multicenter Studies as Topic Multicenter Studies as Topic - standards Mutation Viral Core Proteins Viral Core Proteins - genetics Viral Load Virology |
| title | Expertise of Laboratories in Viral Load Quantification, Genotyping, and Precore Mutant Determination for Hepatitis B Virus in a Multicenter Study |
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