Reliability of the Xpert HPV assay to detect high-risk human papillomavirus DNA in a colposcopy referral population
The Xpert HPV Assay (Xpert; Cepheid, Sunnyvale, CA) was developed for the multianalytic GeneXpert platform. In a colposcopy referral population of 708 women living in the United States, two cervical specimens, A and B, were collected, and both were tested by the Xpert assay for high-risk human papil...
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| Veröffentlicht in: | American journal of clinical pathology 2015-01, Vol.143 (1), p.126-133 |
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| creator | Castle, Philip E Smith, Katherine M Davis, Thomas E Schmeler, Kathleen M Ferris, Daron G Savage, Ashlyn H Gray, Jermaine E Stoler, Mark H Wright, Jr, Thomas C Ferenczy, Alex Einstein, Mark H |
| description | The Xpert HPV Assay (Xpert; Cepheid, Sunnyvale, CA) was developed for the multianalytic GeneXpert platform.
In a colposcopy referral population of 708 women living in the United States, two cervical specimens, A and B, were collected, and both were tested by the Xpert assay for high-risk human papillomavirus (hrHPV) DNA, permitting an evaluation of its test reliability. Specimen B was also tested by Hybrid Capture 2 (hc2; Qiagen, Germantown, MD) and the cobas HPV Test (cobas; Roche Molecular Systems, Pleasanton, CA).
The κ and percent agreement for any hrHPV for the two Xpert results were 0.88 and 94.5%, respectively. There was no statistical difference in testing positive on both specimens by Xpert (P = .62). The sensitivity for detection of cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) was 89.0% using specimen A and 90.4% using specimen B for Xpert, 90.4% for cobas, and 81.6% for hc2.
The Xpert assay was sensitive and reliable for the detection of hrHPV and the identification of women with CIN2+. |
| doi_str_mv | 10.1309/AJCP4Q0NSDHWIZGU |
| format | Article |
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In a colposcopy referral population of 708 women living in the United States, two cervical specimens, A and B, were collected, and both were tested by the Xpert assay for high-risk human papillomavirus (hrHPV) DNA, permitting an evaluation of its test reliability. Specimen B was also tested by Hybrid Capture 2 (hc2; Qiagen, Germantown, MD) and the cobas HPV Test (cobas; Roche Molecular Systems, Pleasanton, CA).
The κ and percent agreement for any hrHPV for the two Xpert results were 0.88 and 94.5%, respectively. There was no statistical difference in testing positive on both specimens by Xpert (P = .62). The sensitivity for detection of cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) was 89.0% using specimen A and 90.4% using specimen B for Xpert, 90.4% for cobas, and 81.6% for hc2.
The Xpert assay was sensitive and reliable for the detection of hrHPV and the identification of women with CIN2+.</description><identifier>ISSN: 0002-9173</identifier><identifier>EISSN: 1943-7722</identifier><identifier>DOI: 10.1309/AJCP4Q0NSDHWIZGU</identifier><identifier>PMID: 25511151</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Cervical Intraepithelial Neoplasia - diagnosis ; Colposcopy ; Female ; Humans ; Molecular Diagnostic Techniques - methods ; Papillomavirus Infections - diagnosis ; Referral and Consultation ; Reproducibility of Results ; Sensitivity and Specificity ; Uterine Cervical Neoplasms - diagnosis</subject><ispartof>American journal of clinical pathology, 2015-01, Vol.143 (1), p.126-133</ispartof><rights>Copyright© by the American Society for Clinical Pathology.</rights><rights>Copyright American Society for Clinical Pathology Jan 2015</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c327t-93d922fc39f616c9aa75b09194ab4992e293928024c86527232781056b0de1a93</citedby><cites>FETCH-LOGICAL-c327t-93d922fc39f616c9aa75b09194ab4992e293928024c86527232781056b0de1a93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27903,27904</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25511151$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Castle, Philip E</creatorcontrib><creatorcontrib>Smith, Katherine M</creatorcontrib><creatorcontrib>Davis, Thomas E</creatorcontrib><creatorcontrib>Schmeler, Kathleen M</creatorcontrib><creatorcontrib>Ferris, Daron G</creatorcontrib><creatorcontrib>Savage, Ashlyn H</creatorcontrib><creatorcontrib>Gray, Jermaine E</creatorcontrib><creatorcontrib>Stoler, Mark H</creatorcontrib><creatorcontrib>Wright, Jr, Thomas C</creatorcontrib><creatorcontrib>Ferenczy, Alex</creatorcontrib><creatorcontrib>Einstein, Mark H</creatorcontrib><title>Reliability of the Xpert HPV assay to detect high-risk human papillomavirus DNA in a colposcopy referral population</title><title>American journal of clinical pathology</title><addtitle>Am J Clin Pathol</addtitle><description>The Xpert HPV Assay (Xpert; Cepheid, Sunnyvale, CA) was developed for the multianalytic GeneXpert platform.
In a colposcopy referral population of 708 women living in the United States, two cervical specimens, A and B, were collected, and both were tested by the Xpert assay for high-risk human papillomavirus (hrHPV) DNA, permitting an evaluation of its test reliability. Specimen B was also tested by Hybrid Capture 2 (hc2; Qiagen, Germantown, MD) and the cobas HPV Test (cobas; Roche Molecular Systems, Pleasanton, CA).
The κ and percent agreement for any hrHPV for the two Xpert results were 0.88 and 94.5%, respectively. There was no statistical difference in testing positive on both specimens by Xpert (P = .62). The sensitivity for detection of cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) was 89.0% using specimen A and 90.4% using specimen B for Xpert, 90.4% for cobas, and 81.6% for hc2.
The Xpert assay was sensitive and reliable for the detection of hrHPV and the identification of women with CIN2+.</description><subject>Cervical Intraepithelial Neoplasia - diagnosis</subject><subject>Colposcopy</subject><subject>Female</subject><subject>Humans</subject><subject>Molecular Diagnostic Techniques - methods</subject><subject>Papillomavirus Infections - diagnosis</subject><subject>Referral and Consultation</subject><subject>Reproducibility of Results</subject><subject>Sensitivity and Specificity</subject><subject>Uterine Cervical Neoplasms - diagnosis</subject><issn>0002-9173</issn><issn>1943-7722</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNpdkTlPAzEUhC0EgnD0VMgSDc2Cj71cRuFIEApnANGsvI6XGLxrY3uR8u8xIlDwmmm-Gb3RALCP0TGmiJ0ML0c36S2a3p-OnyYvF7M1MMAspUlRELIOBgghkjBc0C2w7f0bQpiUKN0EWyTLMMYZHgB_J7XitdIqLKFpYFhI-GylC3B88wi593wJg4FzGaQIcKFeF4lT_h0u-pZ30HKrtDYt_1Su9_B0OoSqgxwKo63xwtgldLKRznENrbG95kGZbhdsNFx7ubfSHTA7P3sYjZOr64vJaHiVCEqKkDA6Z4Q0grImx7lgnBdZjVgsyOuUMSIJoywWIqko84wUJLpKjLK8RnOJOaM74Ogn1zrz0UsfqlZ5IbXmnTS9r3BOiywnFJURPfyHvpnedfG7SGXx8jL9ptAPJZzxPjarrFMtd8sKo-p7kOr_INFysAru61bO_wy_C9Av43iGjg</recordid><startdate>201501</startdate><enddate>201501</enddate><creator>Castle, Philip E</creator><creator>Smith, Katherine M</creator><creator>Davis, Thomas E</creator><creator>Schmeler, Kathleen M</creator><creator>Ferris, Daron G</creator><creator>Savage, Ashlyn H</creator><creator>Gray, Jermaine E</creator><creator>Stoler, Mark H</creator><creator>Wright, Jr, Thomas C</creator><creator>Ferenczy, Alex</creator><creator>Einstein, Mark H</creator><general>Oxford University Press</general><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>3V.</scope><scope>7RV</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope></search><sort><creationdate>201501</creationdate><title>Reliability of the Xpert HPV assay to detect high-risk human papillomavirus DNA in a colposcopy referral population</title><author>Castle, Philip E ; Smith, Katherine M ; Davis, Thomas E ; Schmeler, Kathleen M ; Ferris, Daron G ; Savage, Ashlyn H ; Gray, Jermaine E ; Stoler, Mark H ; Wright, Jr, Thomas C ; Ferenczy, Alex ; Einstein, Mark H</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c327t-93d922fc39f616c9aa75b09194ab4992e293928024c86527232781056b0de1a93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Cervical Intraepithelial Neoplasia - diagnosis</topic><topic>Colposcopy</topic><topic>Female</topic><topic>Humans</topic><topic>Molecular Diagnostic Techniques - methods</topic><topic>Papillomavirus Infections - diagnosis</topic><topic>Referral and Consultation</topic><topic>Reproducibility of Results</topic><topic>Sensitivity and Specificity</topic><topic>Uterine Cervical Neoplasms - diagnosis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Castle, Philip E</creatorcontrib><creatorcontrib>Smith, Katherine M</creatorcontrib><creatorcontrib>Davis, Thomas E</creatorcontrib><creatorcontrib>Schmeler, Kathleen M</creatorcontrib><creatorcontrib>Ferris, Daron G</creatorcontrib><creatorcontrib>Savage, Ashlyn H</creatorcontrib><creatorcontrib>Gray, Jermaine E</creatorcontrib><creatorcontrib>Stoler, Mark H</creatorcontrib><creatorcontrib>Wright, Jr, Thomas C</creatorcontrib><creatorcontrib>Ferenczy, Alex</creatorcontrib><creatorcontrib>Einstein, Mark H</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biological Science Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><jtitle>American journal of clinical pathology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Castle, Philip E</au><au>Smith, Katherine M</au><au>Davis, Thomas E</au><au>Schmeler, Kathleen M</au><au>Ferris, Daron G</au><au>Savage, Ashlyn H</au><au>Gray, Jermaine E</au><au>Stoler, Mark H</au><au>Wright, Jr, Thomas C</au><au>Ferenczy, Alex</au><au>Einstein, Mark H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Reliability of the Xpert HPV assay to detect high-risk human papillomavirus DNA in a colposcopy referral population</atitle><jtitle>American journal of clinical pathology</jtitle><addtitle>Am J Clin Pathol</addtitle><date>2015-01</date><risdate>2015</risdate><volume>143</volume><issue>1</issue><spage>126</spage><epage>133</epage><pages>126-133</pages><issn>0002-9173</issn><eissn>1943-7722</eissn><abstract>The Xpert HPV Assay (Xpert; Cepheid, Sunnyvale, CA) was developed for the multianalytic GeneXpert platform.
In a colposcopy referral population of 708 women living in the United States, two cervical specimens, A and B, were collected, and both were tested by the Xpert assay for high-risk human papillomavirus (hrHPV) DNA, permitting an evaluation of its test reliability. Specimen B was also tested by Hybrid Capture 2 (hc2; Qiagen, Germantown, MD) and the cobas HPV Test (cobas; Roche Molecular Systems, Pleasanton, CA).
The κ and percent agreement for any hrHPV for the two Xpert results were 0.88 and 94.5%, respectively. There was no statistical difference in testing positive on both specimens by Xpert (P = .62). The sensitivity for detection of cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) was 89.0% using specimen A and 90.4% using specimen B for Xpert, 90.4% for cobas, and 81.6% for hc2.
The Xpert assay was sensitive and reliable for the detection of hrHPV and the identification of women with CIN2+.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>25511151</pmid><doi>10.1309/AJCP4Q0NSDHWIZGU</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0002-9173 |
| ispartof | American journal of clinical pathology, 2015-01, Vol.143 (1), p.126-133 |
| issn | 0002-9173 1943-7722 |
| language | eng |
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| source | Oxford University Press Journals All Titles (1996-Current); MEDLINE; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals |
| subjects | Cervical Intraepithelial Neoplasia - diagnosis Colposcopy Female Humans Molecular Diagnostic Techniques - methods Papillomavirus Infections - diagnosis Referral and Consultation Reproducibility of Results Sensitivity and Specificity Uterine Cervical Neoplasms - diagnosis |
| title | Reliability of the Xpert HPV assay to detect high-risk human papillomavirus DNA in a colposcopy referral population |
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