Analytical evaluation of a new Microdisk™ technology-based multiplex HPV genotyping system – the QPLEX™ HPV genotyping kit
Recently, the QPLEX™ human papillomavirus (HPV) genotyping kit (QuantaMatrix, Seoul, Korea), a Microdisk™ technology-based multiplex system, was developed to detect 32 HPV genotypes. We evaluated the analytical performance of this kit by conducting a comparison study, precision evaluation and interf...
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| Veröffentlicht in: | Journal of laboratory medicine 2019-08, Vol.43 (4), p.201-209 |
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| creator | Lim, Yong Kwan Kweon, Oh Joo Choi, Jee-Hye Park, Seungman Jung, Keumsim Kim, Jiyeong Park, Ae Ja |
| description | Recently, the QPLEX™ human papillomavirus (HPV) genotyping kit (QuantaMatrix, Seoul, Korea), a Microdisk™ technology-based multiplex system, was developed to detect 32 HPV genotypes. We evaluated the analytical performance of this kit by conducting a comparison study, precision evaluation and interference testing.A total of 1594 cervical swab specimens were used to compare the QPLEX™ HPV genotyping kit with other commercially available kits (GeneFinder HPV Liquid Bead MicroArray Genotype polymerase chain reaction [PCR] kit, Infopia, Seoul, Korea; PANArray™ HPV Genotyping Chip, PANAGENE, Daejeon, Korea). For the determination of precision, we evaluated four types of precision profiles: repeatability, lot-to-lot variability, operator-to-operator variability and site-to-site variability. In addition, interference tests were performed with various interferents.The results of the QPLEX™ HPV genotyping kit showed almost perfect agreement with the other commercially available HPV genotyping assays. The combined precision was acceptable. In addition, there was no tested interferent that affected the results of the QPLEX™ HPV genotyping kit.The QPLEX™ HPV genotyping kit showed acceptable analytical performance in our study. This assay could be a suitable option for HPV genotyping in routine and follow-up tests. |
| doi_str_mv | 10.1515/labmed-2019-0038 |
| format | Article |
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We evaluated the analytical performance of this kit by conducting a comparison study, precision evaluation and interference testing.A total of 1594 cervical swab specimens were used to compare the QPLEX™ HPV genotyping kit with other commercially available kits (GeneFinder HPV Liquid Bead MicroArray Genotype polymerase chain reaction [PCR] kit, Infopia, Seoul, Korea; PANArray™ HPV Genotyping Chip, PANAGENE, Daejeon, Korea). For the determination of precision, we evaluated four types of precision profiles: repeatability, lot-to-lot variability, operator-to-operator variability and site-to-site variability. In addition, interference tests were performed with various interferents.The results of the QPLEX™ HPV genotyping kit showed almost perfect agreement with the other commercially available HPV genotyping assays. The combined precision was acceptable. In addition, there was no tested interferent that affected the results of the QPLEX™ HPV genotyping kit.The QPLEX™ HPV genotyping kit showed acceptable analytical performance in our study. This assay could be a suitable option for HPV genotyping in routine and follow-up tests.</description><identifier>ISSN: 0342-3026</identifier><identifier>ISSN: 2567-9430</identifier><identifier>EISSN: 1439-0477</identifier><identifier>EISSN: 2567-9449</identifier><identifier>DOI: 10.1515/labmed-2019-0038</identifier><language>eng</language><publisher>Berlin: De Gruyter</publisher><subject>cervical cancer ; Evaluation ; Genotypes ; Genotyping ; Human papillomavirus ; human papillomavirus (HPV) ; Interference ; Mathematical analysis ; Multiplexing ; Polymerase chain reaction ; Technology ; Test procedures ; Variability</subject><ispartof>Journal of laboratory medicine, 2019-08, Vol.43 (4), p.201-209</ispartof><rights>2019. 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Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c358t-71028f7ed6ac66bb68ce5e2faf96d2fbf718f7ac539e6fd26461ba9645e783be3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,860,27901,27902</link.rule.ids></links><search><creatorcontrib>Lim, Yong Kwan</creatorcontrib><creatorcontrib>Kweon, Oh Joo</creatorcontrib><creatorcontrib>Choi, Jee-Hye</creatorcontrib><creatorcontrib>Park, Seungman</creatorcontrib><creatorcontrib>Jung, Keumsim</creatorcontrib><creatorcontrib>Kim, Jiyeong</creatorcontrib><creatorcontrib>Park, Ae Ja</creatorcontrib><title>Analytical evaluation of a new Microdisk™ technology-based multiplex HPV genotyping system – the QPLEX™ HPV genotyping kit</title><title>Journal of laboratory medicine</title><description>Recently, the QPLEX™ human papillomavirus (HPV) genotyping kit (QuantaMatrix, Seoul, Korea), a Microdisk™ technology-based multiplex system, was developed to detect 32 HPV genotypes. We evaluated the analytical performance of this kit by conducting a comparison study, precision evaluation and interference testing.A total of 1594 cervical swab specimens were used to compare the QPLEX™ HPV genotyping kit with other commercially available kits (GeneFinder HPV Liquid Bead MicroArray Genotype polymerase chain reaction [PCR] kit, Infopia, Seoul, Korea; PANArray™ HPV Genotyping Chip, PANAGENE, Daejeon, Korea). For the determination of precision, we evaluated four types of precision profiles: repeatability, lot-to-lot variability, operator-to-operator variability and site-to-site variability. In addition, interference tests were performed with various interferents.The results of the QPLEX™ HPV genotyping kit showed almost perfect agreement with the other commercially available HPV genotyping assays. The combined precision was acceptable. In addition, there was no tested interferent that affected the results of the QPLEX™ HPV genotyping kit.The QPLEX™ HPV genotyping kit showed acceptable analytical performance in our study. This assay could be a suitable option for HPV genotyping in routine and follow-up tests.</description><subject>cervical cancer</subject><subject>Evaluation</subject><subject>Genotypes</subject><subject>Genotyping</subject><subject>Human papillomavirus</subject><subject>human papillomavirus (HPV)</subject><subject>Interference</subject><subject>Mathematical analysis</subject><subject>Multiplexing</subject><subject>Polymerase chain reaction</subject><subject>Technology</subject><subject>Test procedures</subject><subject>Variability</subject><issn>0342-3026</issn><issn>2567-9430</issn><issn>1439-0477</issn><issn>2567-9449</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><recordid>eNp1kc1Kw0AUhQdRsFb3LgdcR-cnmSQboRS1QsUKKu7CJLmTpp0mNTOxZteFb-Ab-Gh9EhMiCIKre-Cec-B-F6FTSs6pR70LLeMVpA4jNHQI4cEeGlCXt9r1_X00INxlDidMHKIjYxaEUD9kZIC2o0LqxuaJ1BjepK6lzcsClwpLXMAG3-VJVaa5We4-vrCFZF6UuswaJ5YGUryqtc3XGt7xZPaMMyhK26zzIsOmMRZWeLf9xHYO-GE2vXrpGv7Ylrk9RgdKagMnP3OInq6vHscTZ3p_czseTZ2Ee4F1fEpYoHxIhUyEiGMRJOABU1KFImUqVj5t1zLxeAhCpUy4gsYyFK4HfsBj4EN01veuq_K1BmOjRVlX7fEmYswnAQsD4rUu0rvaq42pQEXrKl_JqokoiTrOUc856jhHHec2ctlHNlJbqFLIqrppxW__f1G3_Qmh_BuHXYtT</recordid><startdate>20190827</startdate><enddate>20190827</enddate><creator>Lim, Yong Kwan</creator><creator>Kweon, Oh Joo</creator><creator>Choi, Jee-Hye</creator><creator>Park, Seungman</creator><creator>Jung, Keumsim</creator><creator>Kim, Jiyeong</creator><creator>Park, Ae Ja</creator><general>De Gruyter</general><general>Walter de Gruyter GmbH</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7QL</scope><scope>7QO</scope><scope>7T7</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>P64</scope><scope>RC3</scope></search><sort><creationdate>20190827</creationdate><title>Analytical evaluation of a new Microdisk™ technology-based multiplex HPV genotyping system – the QPLEX™ HPV genotyping kit</title><author>Lim, Yong Kwan ; Kweon, Oh Joo ; Choi, Jee-Hye ; Park, Seungman ; Jung, Keumsim ; Kim, Jiyeong ; Park, Ae Ja</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c358t-71028f7ed6ac66bb68ce5e2faf96d2fbf718f7ac539e6fd26461ba9645e783be3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>cervical cancer</topic><topic>Evaluation</topic><topic>Genotypes</topic><topic>Genotyping</topic><topic>Human papillomavirus</topic><topic>human papillomavirus (HPV)</topic><topic>Interference</topic><topic>Mathematical analysis</topic><topic>Multiplexing</topic><topic>Polymerase chain reaction</topic><topic>Technology</topic><topic>Test procedures</topic><topic>Variability</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Lim, Yong Kwan</creatorcontrib><creatorcontrib>Kweon, Oh Joo</creatorcontrib><creatorcontrib>Choi, Jee-Hye</creatorcontrib><creatorcontrib>Park, Seungman</creatorcontrib><creatorcontrib>Jung, Keumsim</creatorcontrib><creatorcontrib>Kim, Jiyeong</creatorcontrib><creatorcontrib>Park, Ae Ja</creatorcontrib><collection>CrossRef</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><jtitle>Journal of laboratory medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lim, Yong Kwan</au><au>Kweon, Oh Joo</au><au>Choi, Jee-Hye</au><au>Park, Seungman</au><au>Jung, Keumsim</au><au>Kim, Jiyeong</au><au>Park, Ae Ja</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Analytical evaluation of a new Microdisk™ technology-based multiplex HPV genotyping system – the QPLEX™ HPV genotyping kit</atitle><jtitle>Journal of laboratory medicine</jtitle><date>2019-08-27</date><risdate>2019</risdate><volume>43</volume><issue>4</issue><spage>201</spage><epage>209</epage><pages>201-209</pages><issn>0342-3026</issn><issn>2567-9430</issn><eissn>1439-0477</eissn><eissn>2567-9449</eissn><abstract>Recently, the QPLEX™ human papillomavirus (HPV) genotyping kit (QuantaMatrix, Seoul, Korea), a Microdisk™ technology-based multiplex system, was developed to detect 32 HPV genotypes. We evaluated the analytical performance of this kit by conducting a comparison study, precision evaluation and interference testing.A total of 1594 cervical swab specimens were used to compare the QPLEX™ HPV genotyping kit with other commercially available kits (GeneFinder HPV Liquid Bead MicroArray Genotype polymerase chain reaction [PCR] kit, Infopia, Seoul, Korea; PANArray™ HPV Genotyping Chip, PANAGENE, Daejeon, Korea). For the determination of precision, we evaluated four types of precision profiles: repeatability, lot-to-lot variability, operator-to-operator variability and site-to-site variability. In addition, interference tests were performed with various interferents.The results of the QPLEX™ HPV genotyping kit showed almost perfect agreement with the other commercially available HPV genotyping assays. The combined precision was acceptable. In addition, there was no tested interferent that affected the results of the QPLEX™ HPV genotyping kit.The QPLEX™ HPV genotyping kit showed acceptable analytical performance in our study. This assay could be a suitable option for HPV genotyping in routine and follow-up tests.</abstract><cop>Berlin</cop><pub>De Gruyter</pub><doi>10.1515/labmed-2019-0038</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| source | DOAJ Directory of Open Access Journals; Alma/SFX Local Collection; Walter De Gruyter: Open Access Journals; EZB Electronic Journals Library |
| subjects | cervical cancer Evaluation Genotypes Genotyping Human papillomavirus human papillomavirus (HPV) Interference Mathematical analysis Multiplexing Polymerase chain reaction Technology Test procedures Variability |
| title | Analytical evaluation of a new Microdisk™ technology-based multiplex HPV genotyping system – the QPLEX™ HPV genotyping kit |
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