Analytical characterization of the APTIMA® HPV Assay
ABSTRACT Background Human papillomavirus (HPV) testing has improved the sensitivity for the detection of cervical pre-cancer and cancer as compared to Pap testing. Several HPV tests are commercially available and most target the DNA from 13 or 14 high-risk HPV types. The APTIMA® HPV Assay however, d...
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| Veröffentlicht in: | Journal of clinical virology 2009-07, Vol.45, p.S39-S47 |
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| description | ABSTRACT Background Human papillomavirus (HPV) testing has improved the sensitivity for the detection of cervical pre-cancer and cancer as compared to Pap testing. Several HPV tests are commercially available and most target the DNA from 13 or 14 high-risk HPV types. The APTIMA® HPV Assay however, detects HPV E6/E7 mRNA from 14 high-risk types of HPV: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. Objective To determine the analytical performance characteristics of the APTIMA HPV Assay. Study Design Analytical sensitivity, analytical specificity, reproducibility, and the effect of potentially interfering substances was determined for the APTIMA HPV Assay on both the DTS (semi-automated) and TIGRIS DTS (fully automated) systems. Results The 95% detection limit for both systems was between 17 and 488 copies/reaction, depending on the HPV type. The assay did not cross-react with normal flora and opportunistic organisms that may be found in cervical samples, or low-risk HPV types. Spermicides, anti-fungal and anti-itch medications, whole blood, glacial acetic acid, and most lubricants did not interfere with assay performance. Those lubricants containing polyquaternium 15 did interfere with assay performance. Inter-instrument, inter-operator, inter-lot, and inter-run signal variability were 99% of the data. Intra-run variability was |
| doi_str_mv | 10.1016/S1386-6532(09)70007-1 |
| format | Article |
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Several HPV tests are commercially available and most target the DNA from 13 or 14 high-risk HPV types. The APTIMA® HPV Assay however, detects HPV E6/E7 mRNA from 14 high-risk types of HPV: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. Objective To determine the analytical performance characteristics of the APTIMA HPV Assay. Study Design Analytical sensitivity, analytical specificity, reproducibility, and the effect of potentially interfering substances was determined for the APTIMA HPV Assay on both the DTS (semi-automated) and TIGRIS DTS (fully automated) systems. Results The 95% detection limit for both systems was between 17 and 488 copies/reaction, depending on the HPV type. The assay did not cross-react with normal flora and opportunistic organisms that may be found in cervical samples, or low-risk HPV types. Spermicides, anti-fungal and anti-itch medications, whole blood, glacial acetic acid, and most lubricants did not interfere with assay performance. Those lubricants containing polyquaternium 15 did interfere with assay performance. Inter-instrument, inter-operator, inter-lot, and inter-run signal variability were <10% for >99% of the data. Intra-run variability was <15%, except for those samples with concentrations at or below the 95% detection limit of the assay. Conclusions: Based upon the analytical sensitivity, analytical specificity, and low variability, the APTIMA HPV Assay showed excellent performance and robustness.</description><identifier>ISSN: 1386-6532</identifier><identifier>EISSN: 1873-5967</identifier><identifier>DOI: 10.1016/S1386-6532(09)70007-1</identifier><identifier>PMID: 19651368</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Allergy and Immunology ; analytical sensitivity ; analytical specificity reproducibility ; APTIMA® HPV Assay ; Automation ; Cervix Uteri - virology ; E6/E7 mRNA ; Female ; Gene Expression Profiling - methods ; HPV ; Human papillomavirus ; Humans ; Infectious Disease ; Oncogene Proteins, Viral - biosynthesis ; Oncogene Proteins, Viral - genetics ; Papillomaviridae - pathogenicity ; Papillomavirus Infections - virology ; Reagent Kits, Diagnostic ; Reproducibility of Results ; RNA, Messenger - biosynthesis ; RNA, Messenger - genetics ; RNA, Viral - biosynthesis ; RNA, Viral - genetics ; Sensitivity and Specificity ; Uterine Cervical Neoplasms - diagnosis</subject><ispartof>Journal of clinical virology, 2009-07, Vol.45, p.S39-S47</ispartof><rights>Elsevier B.V.</rights><rights>2009 Elsevier B.V.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c449t-664d9f785db17627283737a388efae3214cf3509b641968053332460855b9b093</citedby><cites>FETCH-LOGICAL-c449t-664d9f785db17627283737a388efae3214cf3509b641968053332460855b9b093</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/S1386-6532(09)70007-1$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>315,782,786,3554,27933,27934,46004</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19651368$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dockter, Janel</creatorcontrib><creatorcontrib>Schroder, Astrid</creatorcontrib><creatorcontrib>Eaton, Barbara</creatorcontrib><creatorcontrib>Wang, Ann</creatorcontrib><creatorcontrib>Sikhamsay, Nathan</creatorcontrib><creatorcontrib>Morales, Liezel</creatorcontrib><creatorcontrib>Giachetti, Cristina</creatorcontrib><title>Analytical characterization of the APTIMA® HPV Assay</title><title>Journal of clinical virology</title><addtitle>J Clin Virol</addtitle><description>ABSTRACT Background Human papillomavirus (HPV) testing has improved the sensitivity for the detection of cervical pre-cancer and cancer as compared to Pap testing. Several HPV tests are commercially available and most target the DNA from 13 or 14 high-risk HPV types. The APTIMA® HPV Assay however, detects HPV E6/E7 mRNA from 14 high-risk types of HPV: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. Objective To determine the analytical performance characteristics of the APTIMA HPV Assay. Study Design Analytical sensitivity, analytical specificity, reproducibility, and the effect of potentially interfering substances was determined for the APTIMA HPV Assay on both the DTS (semi-automated) and TIGRIS DTS (fully automated) systems. Results The 95% detection limit for both systems was between 17 and 488 copies/reaction, depending on the HPV type. The assay did not cross-react with normal flora and opportunistic organisms that may be found in cervical samples, or low-risk HPV types. Spermicides, anti-fungal and anti-itch medications, whole blood, glacial acetic acid, and most lubricants did not interfere with assay performance. Those lubricants containing polyquaternium 15 did interfere with assay performance. Inter-instrument, inter-operator, inter-lot, and inter-run signal variability were <10% for >99% of the data. Intra-run variability was <15%, except for those samples with concentrations at or below the 95% detection limit of the assay. Conclusions: Based upon the analytical sensitivity, analytical specificity, and low variability, the APTIMA HPV Assay showed excellent performance and robustness.</description><subject>Allergy and Immunology</subject><subject>analytical sensitivity</subject><subject>analytical specificity reproducibility</subject><subject>APTIMA® HPV Assay</subject><subject>Automation</subject><subject>Cervix Uteri - virology</subject><subject>E6/E7 mRNA</subject><subject>Female</subject><subject>Gene Expression Profiling - methods</subject><subject>HPV</subject><subject>Human papillomavirus</subject><subject>Humans</subject><subject>Infectious Disease</subject><subject>Oncogene Proteins, Viral - biosynthesis</subject><subject>Oncogene Proteins, Viral - genetics</subject><subject>Papillomaviridae - pathogenicity</subject><subject>Papillomavirus Infections - virology</subject><subject>Reagent Kits, Diagnostic</subject><subject>Reproducibility of Results</subject><subject>RNA, Messenger - biosynthesis</subject><subject>RNA, Messenger - genetics</subject><subject>RNA, Viral - biosynthesis</subject><subject>RNA, Viral - genetics</subject><subject>Sensitivity and Specificity</subject><subject>Uterine Cervical Neoplasms - diagnosis</subject><issn>1386-6532</issn><issn>1873-5967</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkctO3DAUhi1UBHToI4CyqugicBzfN1TRqAUkECOVdms5zokwZBJqZ5CmD9WH6JM1c0FIbFj5LL7_P9Z3CDmicEqByrMflGmZS8GKEzBfFAConO6QA6oVy4WR6sM4vyD75GNKDwBUMK72yD41UlAm9QERZefa5RC8azN_76LzA8bwxw2h77K-yYZ7zMrZ3dVN-e9vdjn7lZUpueUh2W1cm_DT9p2Qn9-_3U0v8-vbi6tpeZ17zs2QS8lr0ygt6ooqWahCM8WUY1pj45AVlPuGCTCV5OOPNAjGWMElaCEqU4FhE_J50_sU-98LTIOdh-SxbV2H_SJZqYTgwNm7YAFaFwDFCIoN6GOfUsTGPsUwd3FpKdiVWLsWa1fWLBi7FmvpmDveLlhUc6xfU1uTI_B1A-Do4zlgtMkH7DzWIaIfbN2Hd1ecv2nwbehWl3nEJaaHfhHHWyVLbRpzm5JVB5h1A2X_ASCjmTo</recordid><startdate>20090701</startdate><enddate>20090701</enddate><creator>Dockter, Janel</creator><creator>Schroder, Astrid</creator><creator>Eaton, Barbara</creator><creator>Wang, Ann</creator><creator>Sikhamsay, Nathan</creator><creator>Morales, Liezel</creator><creator>Giachetti, Cristina</creator><general>Elsevier B.V</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>7U9</scope><scope>H94</scope><scope>M7N</scope><scope>7X8</scope></search><sort><creationdate>20090701</creationdate><title>Analytical characterization of the APTIMA® HPV Assay</title><author>Dockter, Janel ; Schroder, Astrid ; Eaton, Barbara ; Wang, Ann ; Sikhamsay, Nathan ; Morales, Liezel ; Giachetti, Cristina</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c449t-664d9f785db17627283737a388efae3214cf3509b641968053332460855b9b093</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Allergy and Immunology</topic><topic>analytical sensitivity</topic><topic>analytical specificity reproducibility</topic><topic>APTIMA® HPV Assay</topic><topic>Automation</topic><topic>Cervix Uteri - virology</topic><topic>E6/E7 mRNA</topic><topic>Female</topic><topic>Gene Expression Profiling - methods</topic><topic>HPV</topic><topic>Human papillomavirus</topic><topic>Humans</topic><topic>Infectious Disease</topic><topic>Oncogene Proteins, Viral - biosynthesis</topic><topic>Oncogene Proteins, Viral - genetics</topic><topic>Papillomaviridae - pathogenicity</topic><topic>Papillomavirus Infections - virology</topic><topic>Reagent Kits, Diagnostic</topic><topic>Reproducibility of Results</topic><topic>RNA, Messenger - biosynthesis</topic><topic>RNA, Messenger - genetics</topic><topic>RNA, Viral - biosynthesis</topic><topic>RNA, Viral - genetics</topic><topic>Sensitivity and Specificity</topic><topic>Uterine Cervical Neoplasms - diagnosis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dockter, Janel</creatorcontrib><creatorcontrib>Schroder, Astrid</creatorcontrib><creatorcontrib>Eaton, Barbara</creatorcontrib><creatorcontrib>Wang, Ann</creatorcontrib><creatorcontrib>Sikhamsay, Nathan</creatorcontrib><creatorcontrib>Morales, Liezel</creatorcontrib><creatorcontrib>Giachetti, Cristina</creatorcontrib><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>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical virology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Dockter, Janel</au><au>Schroder, Astrid</au><au>Eaton, Barbara</au><au>Wang, Ann</au><au>Sikhamsay, Nathan</au><au>Morales, Liezel</au><au>Giachetti, Cristina</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Analytical characterization of the APTIMA® HPV Assay</atitle><jtitle>Journal of clinical virology</jtitle><addtitle>J Clin Virol</addtitle><date>2009-07-01</date><risdate>2009</risdate><volume>45</volume><spage>S39</spage><epage>S47</epage><pages>S39-S47</pages><issn>1386-6532</issn><eissn>1873-5967</eissn><abstract>ABSTRACT Background Human papillomavirus (HPV) testing has improved the sensitivity for the detection of cervical pre-cancer and cancer as compared to Pap testing. Several HPV tests are commercially available and most target the DNA from 13 or 14 high-risk HPV types. The APTIMA® HPV Assay however, detects HPV E6/E7 mRNA from 14 high-risk types of HPV: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. Objective To determine the analytical performance characteristics of the APTIMA HPV Assay. Study Design Analytical sensitivity, analytical specificity, reproducibility, and the effect of potentially interfering substances was determined for the APTIMA HPV Assay on both the DTS (semi-automated) and TIGRIS DTS (fully automated) systems. Results The 95% detection limit for both systems was between 17 and 488 copies/reaction, depending on the HPV type. The assay did not cross-react with normal flora and opportunistic organisms that may be found in cervical samples, or low-risk HPV types. Spermicides, anti-fungal and anti-itch medications, whole blood, glacial acetic acid, and most lubricants did not interfere with assay performance. Those lubricants containing polyquaternium 15 did interfere with assay performance. Inter-instrument, inter-operator, inter-lot, and inter-run signal variability were <10% for >99% of the data. Intra-run variability was <15%, except for those samples with concentrations at or below the 95% detection limit of the assay. Conclusions: Based upon the analytical sensitivity, analytical specificity, and low variability, the APTIMA HPV Assay showed excellent performance and robustness.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>19651368</pmid><doi>10.1016/S1386-6532(09)70007-1</doi></addata></record> |
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| subjects | Allergy and Immunology analytical sensitivity analytical specificity reproducibility APTIMA® HPV Assay Automation Cervix Uteri - virology E6/E7 mRNA Female Gene Expression Profiling - methods HPV Human papillomavirus Humans Infectious Disease Oncogene Proteins, Viral - biosynthesis Oncogene Proteins, Viral - genetics Papillomaviridae - pathogenicity Papillomavirus Infections - virology Reagent Kits, Diagnostic Reproducibility of Results RNA, Messenger - biosynthesis RNA, Messenger - genetics RNA, Viral - biosynthesis RNA, Viral - genetics Sensitivity and Specificity Uterine Cervical Neoplasms - diagnosis |
| title | Analytical characterization of the APTIMA® HPV Assay |
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