Validating a fully automated real-time PCR-based system for use in the molecular diagnostic analysis of colorectal carcinoma: a comparison with NGS and IHC
BackgroundMolecular testing is increasingly needed in colorectal carcinoma (CRC) and the current clinically relevant mutations are in BRAF, KRAS and NRAS. This study aimed to further validate a new alternative polymerase chain reaction (PCR) platform (Idylla, Biocartis) against existing next-generat...
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| Veröffentlicht in: | Journal of clinical pathology 2017-07, Vol.70 (7), p.610-614 |
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| creator | Colling, Richard Wang, Lai Mun Soilleux, Elizabeth |
| description | BackgroundMolecular testing is increasingly needed in colorectal carcinoma (CRC) and the current clinically relevant mutations are in BRAF, KRAS and NRAS. This study aimed to further validate a new alternative polymerase chain reaction (PCR) platform (Idylla, Biocartis) against existing next-generation sequencing (NGS) and immunohistochemistry (IHC) assays.Methods56 Idylla tests were performed on 43 CRC cases, in a total of 74 comparisons against an NGS panel (Ion Torrent) and the VE1 (anti-BRAF) antibody IHC. Discrepant cases were also compared with either conventional (Cobas) or droplet digital PCR (Bio-Rad).ResultsIdylla showed an overall concordance of 100% (95% CI 93% to 100%) with comparator molecular testing and indications were that Idylla is likely to be more sensitive than routine NGS. BRAF IHC showed 90% concordance with NGS (95% CI 70% to 97%).ConclusionsThis study validates Idylla in formalin-fixed, paraffin-embedded CRC tissue. BRAF IHC, however, is an unreliable substitute for molecular testing in CRC. |
| doi_str_mv | 10.1136/jclinpath-2017-204356 |
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This study aimed to further validate a new alternative polymerase chain reaction (PCR) platform (Idylla, Biocartis) against existing next-generation sequencing (NGS) and immunohistochemistry (IHC) assays.Methods56 Idylla tests were performed on 43 CRC cases, in a total of 74 comparisons against an NGS panel (Ion Torrent) and the VE1 (anti-BRAF) antibody IHC. Discrepant cases were also compared with either conventional (Cobas) or droplet digital PCR (Bio-Rad).ResultsIdylla showed an overall concordance of 100% (95% CI 93% to 100%) with comparator molecular testing and indications were that Idylla is likely to be more sensitive than routine NGS. BRAF IHC showed 90% concordance with NGS (95% CI 70% to 97%).ConclusionsThis study validates Idylla in formalin-fixed, paraffin-embedded CRC tissue. BRAF IHC, however, is an unreliable substitute for molecular testing in CRC.</description><identifier>ISSN: 0021-9746</identifier><identifier>EISSN: 1472-4146</identifier><identifier>DOI: 10.1136/jclinpath-2017-204356</identifier><identifier>PMID: 28292978</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject>Archives & records ; Automation ; Colorectal cancer ; Colorectal Neoplasms - diagnosis ; Colorectal Neoplasms - genetics ; GTP Phosphohydrolases - genetics ; Humans ; Immunohistochemistry ; Kinases ; Membrane Proteins - genetics ; Mutation ; Mutation - genetics ; Point-of-Care Systems ; Polymerase chain reaction ; Proto-Oncogene Proteins B-raf - genetics ; Proto-Oncogene Proteins p21(ras) - genetics ; Real-Time Polymerase Chain Reaction - methods ; Task forces ; Tumors</subject><ispartof>Journal of clinical pathology, 2017-07, Vol.70 (7), p.610-614</ispartof><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing</rights><rights>Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.</rights><rights>Copyright: 2017 Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b411t-12a8ab784667c97a3ff63df8e27b4cdf3b0c6eced8bac4122171841b455d0a6b3</citedby><cites>FETCH-LOGICAL-b411t-12a8ab784667c97a3ff63df8e27b4cdf3b0c6eced8bac4122171841b455d0a6b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28292978$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Colling, Richard</creatorcontrib><creatorcontrib>Wang, Lai Mun</creatorcontrib><creatorcontrib>Soilleux, Elizabeth</creatorcontrib><title>Validating a fully automated real-time PCR-based system for use in the molecular diagnostic analysis of colorectal carcinoma: a comparison with NGS and IHC</title><title>Journal of clinical pathology</title><addtitle>J Clin Pathol</addtitle><description>BackgroundMolecular testing is increasingly needed in colorectal carcinoma (CRC) and the current clinically relevant mutations are in BRAF, KRAS and NRAS. This study aimed to further validate a new alternative polymerase chain reaction (PCR) platform (Idylla, Biocartis) against existing next-generation sequencing (NGS) and immunohistochemistry (IHC) assays.Methods56 Idylla tests were performed on 43 CRC cases, in a total of 74 comparisons against an NGS panel (Ion Torrent) and the VE1 (anti-BRAF) antibody IHC. Discrepant cases were also compared with either conventional (Cobas) or droplet digital PCR (Bio-Rad).ResultsIdylla showed an overall concordance of 100% (95% CI 93% to 100%) with comparator molecular testing and indications were that Idylla is likely to be more sensitive than routine NGS. BRAF IHC showed 90% concordance with NGS (95% CI 70% to 97%).ConclusionsThis study validates Idylla in formalin-fixed, paraffin-embedded CRC tissue. BRAF IHC, however, is an unreliable substitute for molecular testing in CRC.</description><subject>Archives & records</subject><subject>Automation</subject><subject>Colorectal cancer</subject><subject>Colorectal Neoplasms - diagnosis</subject><subject>Colorectal Neoplasms - genetics</subject><subject>GTP Phosphohydrolases - genetics</subject><subject>Humans</subject><subject>Immunohistochemistry</subject><subject>Kinases</subject><subject>Membrane Proteins - genetics</subject><subject>Mutation</subject><subject>Mutation - genetics</subject><subject>Point-of-Care Systems</subject><subject>Polymerase chain reaction</subject><subject>Proto-Oncogene Proteins B-raf - genetics</subject><subject>Proto-Oncogene Proteins p21(ras) - genetics</subject><subject>Real-Time Polymerase Chain Reaction - methods</subject><subject>Task forces</subject><subject>Tumors</subject><issn>0021-9746</issn><issn>1472-4146</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqNkcuKFDEUhoMoTjv6CErAjZvS3CpJuZPGucDgDN62xUkqNZ0mVWmTFEM_iy9r2h5n4UY3J3D4_v9APoReUvKWUi7fbW3w8w7KpmGEqjoEb-UjtKJCsUZQIR-jFSGMNp0S8gQ9y3lLCOWK8qfohGnWsU7pFfr5HYIfoPj5FgMelxD2GJYSJyhuwMlBaIqfHL5Zf24M5LrL-1zchMeY8JId9jMuG4enGJxdAiQ8eLidYy7eYpgh7LPPOI7YxhCTswUCtpCsn-uJ9_WkjdMOks9xxne-bPCn8y81N-DLi_Vz9GSEkN2L-_cUfTv7-HV90Vxdn1-uP1w1RlBaGspAg1FaSKlsp4CPo-TDqB1TRthh5IZY6awbtAErKGNUUS2oEW07EJCGn6I3x95dij8Wl0s_-WxdCDC7uOSedlRyJXnb_hvVSumWdppU9PVf6DYuqf7I70Im2oPGSrVHyqaYc3Jjv0t-grTvKekPRP8guj-I7o-ia-7VfftiJjc8pP6YrQA5Amba_mfnLwEHtzQ</recordid><startdate>20170701</startdate><enddate>20170701</enddate><creator>Colling, Richard</creator><creator>Wang, Lai Mun</creator><creator>Soilleux, Elizabeth</creator><general>BMJ Publishing Group LTD</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>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>PHGZM</scope><scope>PHGZT</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>Q9U</scope><scope>7X8</scope><scope>7T5</scope><scope>H94</scope></search><sort><creationdate>20170701</creationdate><title>Validating a fully automated real-time PCR-based system for use in the molecular diagnostic analysis of colorectal carcinoma: a comparison with NGS and IHC</title><author>Colling, Richard ; Wang, Lai Mun ; Soilleux, Elizabeth</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b411t-12a8ab784667c97a3ff63df8e27b4cdf3b0c6eced8bac4122171841b455d0a6b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Archives & records</topic><topic>Automation</topic><topic>Colorectal cancer</topic><topic>Colorectal Neoplasms - diagnosis</topic><topic>Colorectal Neoplasms - genetics</topic><topic>GTP Phosphohydrolases - genetics</topic><topic>Humans</topic><topic>Immunohistochemistry</topic><topic>Kinases</topic><topic>Membrane Proteins - genetics</topic><topic>Mutation</topic><topic>Mutation - genetics</topic><topic>Point-of-Care Systems</topic><topic>Polymerase chain reaction</topic><topic>Proto-Oncogene Proteins B-raf - genetics</topic><topic>Proto-Oncogene Proteins p21(ras) - genetics</topic><topic>Real-Time Polymerase Chain Reaction - methods</topic><topic>Task forces</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Colling, Richard</creatorcontrib><creatorcontrib>Wang, Lai Mun</creatorcontrib><creatorcontrib>Soilleux, Elizabeth</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>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</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>ProQuest Central</collection><collection>BMJ Journals</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>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</collection><collection>ProQuest Central (New)</collection><collection>ProQuest One Academic (New)</collection><collection>ProQuest Health & Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & Nursing</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><jtitle>Journal of clinical pathology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Colling, Richard</au><au>Wang, Lai Mun</au><au>Soilleux, Elizabeth</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Validating a fully automated real-time PCR-based system for use in the molecular diagnostic analysis of colorectal carcinoma: a comparison with NGS and IHC</atitle><jtitle>Journal of clinical pathology</jtitle><addtitle>J Clin Pathol</addtitle><date>2017-07-01</date><risdate>2017</risdate><volume>70</volume><issue>7</issue><spage>610</spage><epage>614</epage><pages>610-614</pages><issn>0021-9746</issn><eissn>1472-4146</eissn><abstract>BackgroundMolecular testing is increasingly needed in colorectal carcinoma (CRC) and the current clinically relevant mutations are in BRAF, KRAS and NRAS. This study aimed to further validate a new alternative polymerase chain reaction (PCR) platform (Idylla, Biocartis) against existing next-generation sequencing (NGS) and immunohistochemistry (IHC) assays.Methods56 Idylla tests were performed on 43 CRC cases, in a total of 74 comparisons against an NGS panel (Ion Torrent) and the VE1 (anti-BRAF) antibody IHC. Discrepant cases were also compared with either conventional (Cobas) or droplet digital PCR (Bio-Rad).ResultsIdylla showed an overall concordance of 100% (95% CI 93% to 100%) with comparator molecular testing and indications were that Idylla is likely to be more sensitive than routine NGS. BRAF IHC showed 90% concordance with NGS (95% CI 70% to 97%).ConclusionsThis study validates Idylla in formalin-fixed, paraffin-embedded CRC tissue. BRAF IHC, however, is an unreliable substitute for molecular testing in CRC.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>28292978</pmid><doi>10.1136/jclinpath-2017-204356</doi><tpages>5</tpages></addata></record> |
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| subjects | Archives & records Automation Colorectal cancer Colorectal Neoplasms - diagnosis Colorectal Neoplasms - genetics GTP Phosphohydrolases - genetics Humans Immunohistochemistry Kinases Membrane Proteins - genetics Mutation Mutation - genetics Point-of-Care Systems Polymerase chain reaction Proto-Oncogene Proteins B-raf - genetics Proto-Oncogene Proteins p21(ras) - genetics Real-Time Polymerase Chain Reaction - methods Task forces Tumors |
| title | Validating a fully automated real-time PCR-based system for use in the molecular diagnostic analysis of colorectal carcinoma: a comparison with NGS and IHC |
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