Prospective Evaluation of the Hybrid Capture 2 and AMPLICOR Human Papillomavirus (HPV) Tests for Detection of 13 High-Risk HPV Genotypes in Atypical Squamous Cells of Uncertain Significance▿
Identifieur interne : 000131 ( Pmc/Checkpoint ); précédent : 000130; suivant : 000132Prospective Evaluation of the Hybrid Capture 2 and AMPLICOR Human Papillomavirus (HPV) Tests for Detection of 13 High-Risk HPV Genotypes in Atypical Squamous Cells of Uncertain Significance▿
Auteurs : Philippe Halfon ; Elisabeth Trepo ; Gilles Antoniotti ; Catherine Bernot ; Philippe Cart-Lamy ; Hacène Khiri ; Didier Thibaud ; Jean Marron ; Agnès Martineau ; Guillaume Pénaranda ; Dominique Benmoura ; Bernard BlancSource :
- Journal of Clinical Microbiology [ 0095-1137 ] ; 2006.
Abstract
The use of high-risk human papillomavirus (hrHPV) testing as an adjunct to cervical cytology in population-based screening programs is currently based on DNA hybridization and PCR assays. The aim of this study was to prospectively assess the diagnostic performance of the Hybrid Capture 2 test (HC2; Digene Corporation) in comparison with that of the recently developed PCR-based AMPLICOR HPV test (Roche Molecular Systems) for the detection of 13 hrHPV types. A reverse line blot hybridization assay (Innogenetics) was used as an internal reference standard in discordant cases. Two hundred seventy-one patients with atypical squamous cells of uncertain significance (ASCUS) in cervical samples underwent hrHPV testing. The chi-square test was performed to compare respective proportions. Totals of 160/271 (59%) and 156/271 (58%) were found to be positive for hrHPV with HC2 and AMPLICOR, respectively. Concordant results were obtained for 235 (86.7%) of the 271 samples (kappa statistic, 0.73 ± 0.04). Considering types 26, 53, and 66 as oncogenic types, negative predictive values (NPVs) of HC2 and AMPLICOR were 92.8% and 87.8%, respectively (difference was not significant), and their respective accuracies were 94.8% and 91.9% (difference was not significant). Considering types 26, 53, and 66 as not oncogenic, the respective HC2 and AMPLICOR NPVs were 92.8% and 97.4% (difference was not significant), and accuracy was significantly higher for the AMPLICOR assay (95.9% versus 90.8% for HC2) (
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DOI: 10.1128/JCM.00992-06
PubMed: 17122007
PubMed Central: 1829033
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Prospective Evaluation of the Hybrid Capture 2 and AMPLICOR Human Papillomavirus (HPV) Tests for Detection of 13 High-Risk HPV Genotypes in Atypical Squamous Cells of Uncertain Significance<xref ref-type="fn" rid="fn1">▿</xref> </title><author><name sortKey="Halfon, Philippe" sort="Halfon, Philippe" uniqKey="Halfon P" first="Philippe" last="Halfon">Philippe Halfon</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Trepo, Elisabeth" sort="Trepo, Elisabeth" uniqKey="Trepo E" first="Elisabeth" last="Trepo">Elisabeth Trepo</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Antoniotti, Gilles" sort="Antoniotti, Gilles" uniqKey="Antoniotti G" first="Gilles" last="Antoniotti">Gilles Antoniotti</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Bernot, Catherine" sort="Bernot, Catherine" uniqKey="Bernot C" first="Catherine" last="Bernot">Catherine Bernot</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Cart Lamy, Philippe" sort="Cart Lamy, Philippe" uniqKey="Cart Lamy P" first="Philippe" last="Cart-Lamy">Philippe Cart-Lamy</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Khiri, Hacene" sort="Khiri, Hacene" uniqKey="Khiri H" first="Hacène" last="Khiri">Hacène Khiri</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Thibaud, Didier" sort="Thibaud, Didier" uniqKey="Thibaud D" first="Didier" last="Thibaud">Didier Thibaud</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Marron, Jean" sort="Marron, Jean" uniqKey="Marron J" first="Jean" last="Marron">Jean Marron</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Martineau, Agnes" sort="Martineau, Agnes" uniqKey="Martineau A" first="Agnès" last="Martineau">Agnès Martineau</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Penaranda, Guillaume" sort="Penaranda, Guillaume" uniqKey="Penaranda G" first="Guillaume" last="Pénaranda">Guillaume Pénaranda</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Benmoura, Dominique" sort="Benmoura, Dominique" uniqKey="Benmoura D" first="Dominique" last="Benmoura">Dominique Benmoura</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Blanc, Bernard" sort="Blanc, Bernard" uniqKey="Blanc B" first="Bernard" last="Blanc">Bernard Blanc</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">17122007</idno><idno type="pmc">1829033</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1829033</idno><idno type="RBID">PMC:1829033</idno><idno type="doi">10.1128/JCM.00992-06</idno><date when="2006">2006</date><idno type="wicri:Area/Pmc/Corpus">000112</idno><idno type="wicri:Area/Pmc/Curation">000110</idno><idno type="wicri:Area/Pmc/Checkpoint">000131</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Prospective Evaluation of the Hybrid Capture 2 and AMPLICOR Human Papillomavirus (HPV) Tests for Detection of 13 High-Risk HPV Genotypes in Atypical Squamous Cells of Uncertain Significance<xref ref-type="fn" rid="fn1">▿</xref> </title><author><name sortKey="Halfon, Philippe" sort="Halfon, Philippe" uniqKey="Halfon P" first="Philippe" last="Halfon">Philippe Halfon</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Trepo, Elisabeth" sort="Trepo, Elisabeth" uniqKey="Trepo E" first="Elisabeth" last="Trepo">Elisabeth Trepo</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Antoniotti, Gilles" sort="Antoniotti, Gilles" uniqKey="Antoniotti G" first="Gilles" last="Antoniotti">Gilles Antoniotti</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Bernot, Catherine" sort="Bernot, Catherine" uniqKey="Bernot C" first="Catherine" last="Bernot">Catherine Bernot</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Cart Lamy, Philippe" sort="Cart Lamy, Philippe" uniqKey="Cart Lamy P" first="Philippe" last="Cart-Lamy">Philippe Cart-Lamy</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Khiri, Hacene" sort="Khiri, Hacene" uniqKey="Khiri H" first="Hacène" last="Khiri">Hacène Khiri</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Thibaud, Didier" sort="Thibaud, Didier" uniqKey="Thibaud D" first="Didier" last="Thibaud">Didier Thibaud</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Marron, Jean" sort="Marron, Jean" uniqKey="Marron J" first="Jean" last="Marron">Jean Marron</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Martineau, Agnes" sort="Martineau, Agnes" uniqKey="Martineau A" first="Agnès" last="Martineau">Agnès Martineau</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Penaranda, Guillaume" sort="Penaranda, Guillaume" uniqKey="Penaranda G" first="Guillaume" last="Pénaranda">Guillaume Pénaranda</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Benmoura, Dominique" sort="Benmoura, Dominique" uniqKey="Benmoura D" first="Dominique" last="Benmoura">Dominique Benmoura</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author><author><name sortKey="Blanc, Bernard" sort="Blanc, Bernard" uniqKey="Blanc B" first="Bernard" last="Blanc">Bernard Blanc</name><affiliation><nlm:aff id="aff1"></nlm:aff></affiliation></author></analytic><series><title level="j">Journal of Clinical Microbiology</title><idno type="ISSN">0095-1137</idno><idno type="eISSN">1098-660X</idno><imprint><date when="2006">2006</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>The use of high-risk human papillomavirus (hrHPV) testing as an adjunct to cervical cytology in population-based screening programs is currently based on DNA hybridization and PCR assays. The aim of this study was to prospectively assess the diagnostic performance of the Hybrid Capture 2 test (HC2; Digene Corporation) in comparison with that of the recently developed PCR-based AMPLICOR HPV test (Roche Molecular Systems) for the detection of 13 hrHPV types. A reverse line blot hybridization assay (Innogenetics) was used as an internal reference standard in discordant cases. Two hundred seventy-one patients with atypical squamous cells of uncertain significance (ASCUS) in cervical samples underwent hrHPV testing. The chi-square test was performed to compare respective proportions. Totals of 160/271 (59%) and 156/271 (58%) were found to be positive for hrHPV with HC2 and AMPLICOR, respectively. Concordant results were obtained for 235 (86.7%) of the 271 samples (kappa statistic, 0.73 ± 0.04). Considering types 26, 53, and 66 as oncogenic types, negative predictive values (NPVs) of HC2 and AMPLICOR were 92.8% and 87.8%, respectively (difference was not significant), and their respective accuracies were 94.8% and 91.9% (difference was not significant). Considering types 26, 53, and 66 as not oncogenic, the respective HC2 and AMPLICOR NPVs were 92.8% and 97.4% (difference was not significant), and accuracy was significantly higher for the AMPLICOR assay (95.9% versus 90.8% for HC2) (<italic>P</italic> < 0.05). For ASCUS samples, the NPV was 92.8% for HC2 testing and might be compromised if the copy number of HPV DNA was low. The NPV was 97.4% for the AMPLICOR assay and might be compromised if HPV types 26, 53, and 66 were considered oncogenic. The accuracy of these two assays is good and is compatible with routine clinical use in the triage of ASCUS cases.</p></div></front></TEI><pmc article-type="research-article"><pmc-comment>The publisher of this article does not allow downloading of the full text in XML form.</pmc-comment>
<front><journal-meta><journal-id journal-id-type="nlm-ta">J Clin Microbiol</journal-id><journal-id journal-id-type="publisher-id">jcm</journal-id><journal-title>Journal of Clinical Microbiology</journal-title><issn pub-type="ppub">0095-1137</issn><issn pub-type="epub">1098-660X</issn><publisher><publisher-name>American Society for Microbiology</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">17122007</article-id><article-id pub-id-type="pmc">1829033</article-id><article-id pub-id-type="publisher-id">0992-06</article-id><article-id pub-id-type="doi">10.1128/JCM.00992-06</article-id><article-categories><subj-group subj-group-type="heading"><subject>Chlamydiology and Rickettsiology</subject></subj-group></article-categories><title-group><article-title>Prospective Evaluation of the Hybrid Capture 2 and AMPLICOR Human Papillomavirus (HPV) Tests for Detection of 13 High-Risk HPV Genotypes in Atypical Squamous Cells of Uncertain Significance<xref ref-type="fn" rid="fn1">▿</xref> </article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Halfon</surname><given-names>Philippe</given-names></name><xref ref-type="aff" rid="aff1">1</xref><xref ref-type="corresp" rid="cor1">*</xref></contrib><contrib contrib-type="author"><name><surname>Trepo</surname><given-names>Elisabeth</given-names></name><xref ref-type="aff" rid="aff1">2</xref></contrib><contrib contrib-type="author"><name><surname>Antoniotti</surname><given-names>Gilles</given-names></name><xref ref-type="aff" rid="aff1">3</xref></contrib><contrib contrib-type="author"><name><surname>Bernot</surname><given-names>Catherine</given-names></name><xref ref-type="aff" rid="aff1">3</xref></contrib><contrib contrib-type="author"><name><surname>Cart-Lamy</surname><given-names>Philippe</given-names></name><xref ref-type="aff" rid="aff1">4</xref></contrib><contrib contrib-type="author"><name><surname>Khiri</surname><given-names>Hacène</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Thibaud</surname><given-names>Didier</given-names></name><xref ref-type="aff" rid="aff1">5</xref></contrib><contrib contrib-type="author"><name><surname>Marron</surname><given-names>Jean</given-names></name><xref ref-type="aff" rid="aff1">6</xref></contrib><contrib contrib-type="author"><name><surname>Martineau</surname><given-names>Agnès</given-names></name><xref ref-type="aff" rid="aff1">1</xref></contrib><contrib contrib-type="author"><name><surname>Pénaranda</surname><given-names>Guillaume</given-names></name><xref ref-type="aff" rid="aff1">7</xref></contrib><contrib contrib-type="author"><name><surname>Benmoura</surname><given-names>Dominique</given-names></name><xref ref-type="aff" rid="aff1">8</xref></contrib><contrib contrib-type="author"><name><surname>Blanc</surname><given-names>Bernard</given-names></name><xref ref-type="aff" rid="aff1">8</xref></contrib><contrib contrib-type="author"><collab> and RBML (Réseau de Biologie Moléculaire Libérale)</collab></contrib></contrib-group><aff id="aff1">Alphabio Laboratory, Marseille, France,<label>1</label> Republic Biology Center, Lyon, France,<label>2</label> Biomedica Laboratory, Aix les Bains, France,<label>3</label> Clinilab Laboratory, Meylan, France,<label>4</label> Sery Laboratory, Le Havre, France,<label>5</label> Clinilab Laboratory, Grenoble, France,<label>6</label> CDL Pharma, Marseille, France,<label>7</label> Department of Gynecology, Ambroise Paré Hospital, Marseille, France<label>8</label></aff><author-notes><fn id="cor1"><label>*</label><p>Corresponding author. Mailing address: Alphabio Laboratory, 23 rue de Friedland, 13006 Marseille, France. Phone: (33)4 91 25 41 00. Fax: (33)4 91 79 20 44. E-mail: <email>philippe.halfon@alphabio.fr</email>.</p></fn></author-notes><pub-date pub-type="ppub"><month>2</month><year>2007</year></pub-date><pub-date pub-type="epub"><day>22</day><month>11</month><year>2006</year></pub-date><volume>45</volume><issue>2</issue><fpage>313</fpage><lpage>316</lpage><history><date date-type="received"><day>12</day><month>5</month><year>2006</year></date><date date-type="rev-recd"><day>28</day><month>8</month><year>2006</year></date><date date-type="accepted"><day>9</day><month>11</month><year>2006</year></date></history><copyright-statement>Copyright © 2007, American Society for Microbiology</copyright-statement><copyright-year>2007</copyright-year><self-uri xlink:title="pdf" xlink:href="zjm00207000313.pdf"></self-uri><abstract><p>The use of high-risk human papillomavirus (hrHPV) testing as an adjunct to cervical cytology in population-based screening programs is currently based on DNA hybridization and PCR assays. The aim of this study was to prospectively assess the diagnostic performance of the Hybrid Capture 2 test (HC2; Digene Corporation) in comparison with that of the recently developed PCR-based AMPLICOR HPV test (Roche Molecular Systems) for the detection of 13 hrHPV types. A reverse line blot hybridization assay (Innogenetics) was used as an internal reference standard in discordant cases. Two hundred seventy-one patients with atypical squamous cells of uncertain significance (ASCUS) in cervical samples underwent hrHPV testing. The chi-square test was performed to compare respective proportions. Totals of 160/271 (59%) and 156/271 (58%) were found to be positive for hrHPV with HC2 and AMPLICOR, respectively. Concordant results were obtained for 235 (86.7%) of the 271 samples (kappa statistic, 0.73 ± 0.04). Considering types 26, 53, and 66 as oncogenic types, negative predictive values (NPVs) of HC2 and AMPLICOR were 92.8% and 87.8%, respectively (difference was not significant), and their respective accuracies were 94.8% and 91.9% (difference was not significant). Considering types 26, 53, and 66 as not oncogenic, the respective HC2 and AMPLICOR NPVs were 92.8% and 97.4% (difference was not significant), and accuracy was significantly higher for the AMPLICOR assay (95.9% versus 90.8% for HC2) (<italic>P</italic> < 0.05). For ASCUS samples, the NPV was 92.8% for HC2 testing and might be compromised if the copy number of HPV DNA was low. The NPV was 97.4% for the AMPLICOR assay and might be compromised if HPV types 26, 53, and 66 were considered oncogenic. The accuracy of these two assays is good and is compatible with routine clinical use in the triage of ASCUS cases.</p></abstract></article-meta></front></pmc><affiliations><list></list><tree><noCountry><name sortKey="Antoniotti, Gilles" sort="Antoniotti, Gilles" uniqKey="Antoniotti G" first="Gilles" last="Antoniotti">Gilles Antoniotti</name><name sortKey="Benmoura, Dominique" sort="Benmoura, Dominique" uniqKey="Benmoura D" first="Dominique" last="Benmoura">Dominique Benmoura</name><name sortKey="Bernot, Catherine" sort="Bernot, Catherine" uniqKey="Bernot C" first="Catherine" last="Bernot">Catherine Bernot</name><name sortKey="Blanc, Bernard" sort="Blanc, Bernard" uniqKey="Blanc B" first="Bernard" last="Blanc">Bernard Blanc</name><name sortKey="Cart Lamy, Philippe" sort="Cart Lamy, Philippe" uniqKey="Cart Lamy P" first="Philippe" last="Cart-Lamy">Philippe Cart-Lamy</name><name sortKey="Halfon, Philippe" sort="Halfon, Philippe" uniqKey="Halfon P" first="Philippe" last="Halfon">Philippe Halfon</name><name sortKey="Khiri, Hacene" sort="Khiri, Hacene" uniqKey="Khiri H" first="Hacène" last="Khiri">Hacène Khiri</name><name sortKey="Marron, Jean" sort="Marron, Jean" uniqKey="Marron J" first="Jean" last="Marron">Jean Marron</name><name sortKey="Martineau, Agnes" sort="Martineau, Agnes" uniqKey="Martineau A" first="Agnès" last="Martineau">Agnès Martineau</name><name sortKey="Penaranda, Guillaume" sort="Penaranda, Guillaume" uniqKey="Penaranda G" first="Guillaume" last="Pénaranda">Guillaume Pénaranda</name><name sortKey="Thibaud, Didier" sort="Thibaud, Didier" uniqKey="Thibaud D" first="Didier" last="Thibaud">Didier Thibaud</name><name sortKey="Trepo, Elisabeth" sort="Trepo, Elisabeth" uniqKey="Trepo E" first="Elisabeth" last="Trepo">Elisabeth Trepo</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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