Novel ALK immunohistochemistry assay (clone OTI1A4, Dako) is a sensitive, reliable marker for identifying ALK rearrangements in lung adenocarcinomas: A validation study
Abstract Objectives We present the first study validating the recent Dako ALK assay (clone OTI1A4, in vitro diagnostic) for detecting ALK rearrangements in lung adenocarcinoma. Methods Lung adenocarcinoma cases between 2011 and 2023 were retrospectively collected to create a cohort of 203 samples. C...
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| Veröffentlicht in: | American journal of clinical pathology 2024-01, Vol.161 (1), p.71-82 |
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| container_title | American journal of clinical pathology |
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| creator | Eren, Ozgur Can Mericoz, Cisel Aydin Bozkurtlar, Emine Bulutay, Pinar Baygul, Arzu Kulac, Ibrahim |
| description | Abstract
Objectives
We present the first study validating the recent Dako ALK assay (clone OTI1A4, in vitro diagnostic) for detecting ALK rearrangements in lung adenocarcinoma.
Methods
Lung adenocarcinoma cases between 2011 and 2023 were retrospectively collected to create a cohort of 203 samples. Cases were stained with Dako ALK OTI1A4 and Ventana ALK D5F3 and reviewed by 3 pathologists independently. Correlation between assays, including their sensitivity and specificity, was evaluated.
Results
The cohort (n = 203) consisted of resections, core needle biopsies, and cell blocks. Agreement between Dako ALK OTI1A4 and Ventana ALK D5F3 assays was “almost perfect,” with κ = 0.89. The sensitivity and specificity of the Dako ALK OTI1A4 assay were 93.3% and 96%, respectively, in a subgroup of 55 molecularly confirmed cases (n = 30 with and n = 25 without ALK rearrangement).
Conclusions
Immunohistochemistry-based assays provide a valid and reasonably priced alternative, especially in settings where molecular confirmatory tests are neither offered nor accessible. Given high interassay and molecular concordance, we propose that the novel Dako OTI1A4 assay can be reliably used to identify cases with ALK rearrangement. |
| doi_str_mv | 10.1093/ajcp/aqad111 |
| format | Article |
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Objectives
We present the first study validating the recent Dako ALK assay (clone OTI1A4, in vitro diagnostic) for detecting ALK rearrangements in lung adenocarcinoma.
Methods
Lung adenocarcinoma cases between 2011 and 2023 were retrospectively collected to create a cohort of 203 samples. Cases were stained with Dako ALK OTI1A4 and Ventana ALK D5F3 and reviewed by 3 pathologists independently. Correlation between assays, including their sensitivity and specificity, was evaluated.
Results
The cohort (n = 203) consisted of resections, core needle biopsies, and cell blocks. Agreement between Dako ALK OTI1A4 and Ventana ALK D5F3 assays was “almost perfect,” with κ = 0.89. The sensitivity and specificity of the Dako ALK OTI1A4 assay were 93.3% and 96%, respectively, in a subgroup of 55 molecularly confirmed cases (n = 30 with and n = 25 without ALK rearrangement).
Conclusions
Immunohistochemistry-based assays provide a valid and reasonably priced alternative, especially in settings where molecular confirmatory tests are neither offered nor accessible. Given high interassay and molecular concordance, we propose that the novel Dako OTI1A4 assay can be reliably used to identify cases with ALK rearrangement.</description><identifier>ISSN: 0002-9173</identifier><identifier>EISSN: 1943-7722</identifier><identifier>DOI: 10.1093/ajcp/aqad111</identifier><identifier>PMID: 37681660</identifier><language>eng</language><publisher>US: Oxford University Press</publisher><subject>Adenocarcinoma of Lung - diagnosis ; Adenocarcinoma of Lung - genetics ; Anaplastic Lymphoma Kinase - genetics ; Gene Rearrangement ; Humans ; Immunohistochemistry ; In Situ Hybridization, Fluorescence ; Lung Neoplasms - diagnosis ; Lung Neoplasms - genetics ; Lung Neoplasms - pathology ; Original ; Receptor Protein-Tyrosine Kinases - genetics ; Retrospective Studies</subject><ispartof>American journal of clinical pathology, 2024-01, Vol.161 (1), p.71-82</ispartof><rights>American Society for Clinical Pathology, 2023. 2023</rights><rights>American Society for Clinical Pathology, 2023.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><orcidid>0000-0003-2003-7567</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,1584,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37681660$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Eren, Ozgur Can</creatorcontrib><creatorcontrib>Mericoz, Cisel Aydin</creatorcontrib><creatorcontrib>Bozkurtlar, Emine</creatorcontrib><creatorcontrib>Bulutay, Pinar</creatorcontrib><creatorcontrib>Baygul, Arzu</creatorcontrib><creatorcontrib>Kulac, Ibrahim</creatorcontrib><title>Novel ALK immunohistochemistry assay (clone OTI1A4, Dako) is a sensitive, reliable marker for identifying ALK rearrangements in lung adenocarcinomas: A validation study</title><title>American journal of clinical pathology</title><addtitle>Am J Clin Pathol</addtitle><description>Abstract
Objectives
We present the first study validating the recent Dako ALK assay (clone OTI1A4, in vitro diagnostic) for detecting ALK rearrangements in lung adenocarcinoma.
Methods
Lung adenocarcinoma cases between 2011 and 2023 were retrospectively collected to create a cohort of 203 samples. Cases were stained with Dako ALK OTI1A4 and Ventana ALK D5F3 and reviewed by 3 pathologists independently. Correlation between assays, including their sensitivity and specificity, was evaluated.
Results
The cohort (n = 203) consisted of resections, core needle biopsies, and cell blocks. Agreement between Dako ALK OTI1A4 and Ventana ALK D5F3 assays was “almost perfect,” with κ = 0.89. The sensitivity and specificity of the Dako ALK OTI1A4 assay were 93.3% and 96%, respectively, in a subgroup of 55 molecularly confirmed cases (n = 30 with and n = 25 without ALK rearrangement).
Conclusions
Immunohistochemistry-based assays provide a valid and reasonably priced alternative, especially in settings where molecular confirmatory tests are neither offered nor accessible. Given high interassay and molecular concordance, we propose that the novel Dako OTI1A4 assay can be reliably used to identify cases with ALK rearrangement.</description><subject>Adenocarcinoma of Lung - diagnosis</subject><subject>Adenocarcinoma of Lung - genetics</subject><subject>Anaplastic Lymphoma Kinase - genetics</subject><subject>Gene Rearrangement</subject><subject>Humans</subject><subject>Immunohistochemistry</subject><subject>In Situ Hybridization, Fluorescence</subject><subject>Lung Neoplasms - diagnosis</subject><subject>Lung Neoplasms - genetics</subject><subject>Lung Neoplasms - pathology</subject><subject>Original</subject><subject>Receptor Protein-Tyrosine Kinases - genetics</subject><subject>Retrospective Studies</subject><issn>0002-9173</issn><issn>1943-7722</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><sourceid>EIF</sourceid><recordid>eNp9kU9vEzEQxS0EoqFw44x8o0hZOrY3691eUFT-VUT0Us7WxOtN3Hrt1N6NtN-Ij4lLQgUXTiPN_PTmzTxCXjN4z6AR53ird-d4jy1j7AmZsaYUhZScPyUzAOBFw6Q4IS9SugVgvIbyOTkRsqpZVcGM_Pwe9sbR5eobtX0_-rC1aQh6a_pc40QxJZzomXbBG3p9c8WW5Zx-xLvwjtpEkSbjkx3s3sxpNM7i2hnaY7wzkXYhUtsaP9husn7ze0c0GCP6jelzP1HrqRvzCDMWNEZtfegxXdAl3aOzLQ42eJqGsZ1ekmcdumReHesp-fH5083l12J1_eXqcrkqtJDlUKBZY1sJuWhqgAVqhgsEXjYAQgPTTPC2q4RotMB63bEGqwXjFUhEs-CMS3FKPhx0d-O6N63OPiM6tYs2nzWpgFb9O_F2qzZhrxjIrCWarHB2VIjhfjRpUPmX2jiH3oQxKV5nAwC1FBmdH1AdQ0rRdI97GKiHdNVDuuqYbsbf_O3tEf4TZwbeHoAw7v4v9QszXbHQ</recordid><startdate>20240104</startdate><enddate>20240104</enddate><creator>Eren, Ozgur Can</creator><creator>Mericoz, Cisel Aydin</creator><creator>Bozkurtlar, Emine</creator><creator>Bulutay, Pinar</creator><creator>Baygul, Arzu</creator><creator>Kulac, Ibrahim</creator><general>Oxford University Press</general><scope>TOX</scope><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>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0003-2003-7567</orcidid></search><sort><creationdate>20240104</creationdate><title>Novel ALK immunohistochemistry assay (clone OTI1A4, Dako) is a sensitive, reliable marker for identifying ALK rearrangements in lung adenocarcinomas: A validation study</title><author>Eren, Ozgur Can ; Mericoz, Cisel Aydin ; Bozkurtlar, Emine ; Bulutay, Pinar ; Baygul, Arzu ; Kulac, Ibrahim</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c374t-aebad637598005ac1a5a0249003c01c132df6339c3a8bf19a6512607aae521273</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adenocarcinoma of Lung - diagnosis</topic><topic>Adenocarcinoma of Lung - genetics</topic><topic>Anaplastic Lymphoma Kinase - genetics</topic><topic>Gene Rearrangement</topic><topic>Humans</topic><topic>Immunohistochemistry</topic><topic>In Situ Hybridization, Fluorescence</topic><topic>Lung Neoplasms - diagnosis</topic><topic>Lung Neoplasms - genetics</topic><topic>Lung Neoplasms - pathology</topic><topic>Original</topic><topic>Receptor Protein-Tyrosine Kinases - genetics</topic><topic>Retrospective Studies</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Eren, Ozgur Can</creatorcontrib><creatorcontrib>Mericoz, Cisel Aydin</creatorcontrib><creatorcontrib>Bozkurtlar, Emine</creatorcontrib><creatorcontrib>Bulutay, Pinar</creatorcontrib><creatorcontrib>Baygul, Arzu</creatorcontrib><creatorcontrib>Kulac, Ibrahim</creatorcontrib><collection>Oxford Journals Open Access Collection</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>American journal of clinical pathology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Eren, Ozgur Can</au><au>Mericoz, Cisel Aydin</au><au>Bozkurtlar, Emine</au><au>Bulutay, Pinar</au><au>Baygul, Arzu</au><au>Kulac, Ibrahim</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Novel ALK immunohistochemistry assay (clone OTI1A4, Dako) is a sensitive, reliable marker for identifying ALK rearrangements in lung adenocarcinomas: A validation study</atitle><jtitle>American journal of clinical pathology</jtitle><addtitle>Am J Clin Pathol</addtitle><date>2024-01-04</date><risdate>2024</risdate><volume>161</volume><issue>1</issue><spage>71</spage><epage>82</epage><pages>71-82</pages><issn>0002-9173</issn><eissn>1943-7722</eissn><abstract>Abstract
Objectives
We present the first study validating the recent Dako ALK assay (clone OTI1A4, in vitro diagnostic) for detecting ALK rearrangements in lung adenocarcinoma.
Methods
Lung adenocarcinoma cases between 2011 and 2023 were retrospectively collected to create a cohort of 203 samples. Cases were stained with Dako ALK OTI1A4 and Ventana ALK D5F3 and reviewed by 3 pathologists independently. Correlation between assays, including their sensitivity and specificity, was evaluated.
Results
The cohort (n = 203) consisted of resections, core needle biopsies, and cell blocks. Agreement between Dako ALK OTI1A4 and Ventana ALK D5F3 assays was “almost perfect,” with κ = 0.89. The sensitivity and specificity of the Dako ALK OTI1A4 assay were 93.3% and 96%, respectively, in a subgroup of 55 molecularly confirmed cases (n = 30 with and n = 25 without ALK rearrangement).
Conclusions
Immunohistochemistry-based assays provide a valid and reasonably priced alternative, especially in settings where molecular confirmatory tests are neither offered nor accessible. Given high interassay and molecular concordance, we propose that the novel Dako OTI1A4 assay can be reliably used to identify cases with ALK rearrangement.</abstract><cop>US</cop><pub>Oxford University Press</pub><pmid>37681660</pmid><doi>10.1093/ajcp/aqad111</doi><tpages>12</tpages><orcidid>https://orcid.org/0000-0003-2003-7567</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0002-9173 |
| ispartof | American journal of clinical pathology, 2024-01, Vol.161 (1), p.71-82 |
| issn | 0002-9173 1943-7722 |
| language | eng |
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| source | MEDLINE; Oxford University Press Journals All Titles (1996-Current) |
| subjects | Adenocarcinoma of Lung - diagnosis Adenocarcinoma of Lung - genetics Anaplastic Lymphoma Kinase - genetics Gene Rearrangement Humans Immunohistochemistry In Situ Hybridization, Fluorescence Lung Neoplasms - diagnosis Lung Neoplasms - genetics Lung Neoplasms - pathology Original Receptor Protein-Tyrosine Kinases - genetics Retrospective Studies |
| title | Novel ALK immunohistochemistry assay (clone OTI1A4, Dako) is a sensitive, reliable marker for identifying ALK rearrangements in lung adenocarcinomas: A validation study |
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