{"title":"应用 IdyllaTM 系统快速评估非小细胞肺癌福尔马林固定和石蜡包埋样本中的表皮生长因子受体突变状态。","authors":"Yun-Jian Xu, Hui Wang, Ting Zhang","doi":"","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>In approximately 80% of the patients with advanced non-small cell lung cancer (NSCLC), the only samples available are cytological material or a limited amount of tissue specimens. Therefore, we aimed to explore the effect of the Idylla™ system for rapid evaluation of epidermal growth factor receptor (<i>EGFR</i>) mutation status in formalin-fixed and paraffin-embedded (FFPE) samples of NSCLC patients.</p><p><strong>Methods: </strong>A total of 221 archived FFPE NSCLC tissue specimens were included in this study. Idylla™ system and amplification refractory mutation system-polymerase chain reaction (ARMS-PCR) were used to detect the <i>EGFR</i> mutation status. The Idylla™ system results and ARMS-PCR results were compared. When results were discordant, the Idylla™ system would be retested, and a third analysis method was performed to confirm test results when possible.</p><p><strong>Results: </strong>Among the 220 valid results of the Idylla™ system, the Idylla™ identified <i>EGFR</i> mutations in 109 cases with an incidence of mutation of 49.55%. The Idylla™ assay results were in complete agreement with the results of the reference methods for 207 cases, yielding an overall accordance of 94.09% (207/220, 95% CI, 90.11%-96.82%). Consequently, the overall concordance with routine reference methods, including further analysis, was found to be 96.81% (213/220, 95% CI: 93.28%-98.60%), with a negative percentage agreement of 97.3% (108/111, 95% CI: 91.72%-99.30%) and a positive percentage agreement of 96.33% (105/109, 95% CI: 90.32%-98.81%).</p><p><strong>Conclusion: </strong>The Idylla™ system is a rapid and effective method that enables sensitive and reliable detection of <i>EGFR</i> mutations in FFPE samples of NSCLC patients, with minimal molecular expertise or infrastructure.</p>","PeriodicalId":8228,"journal":{"name":"Annals of clinical and laboratory science","volume":"54 5","pages":"652-660"},"PeriodicalIF":1.1000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Application of Idylla<sup>TM</sup> System for Rapid Evaluation of <i>EGFR</i> Mutation Status in Formalin-Fixed and Paraffin-Embedded Samples of Non-Small Cell Lung Cancer.\",\"authors\":\"Yun-Jian Xu, Hui Wang, Ting Zhang\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>In approximately 80% of the patients with advanced non-small cell lung cancer (NSCLC), the only samples available are cytological material or a limited amount of tissue specimens. Therefore, we aimed to explore the effect of the Idylla™ system for rapid evaluation of epidermal growth factor receptor (<i>EGFR</i>) mutation status in formalin-fixed and paraffin-embedded (FFPE) samples of NSCLC patients.</p><p><strong>Methods: </strong>A total of 221 archived FFPE NSCLC tissue specimens were included in this study. Idylla™ system and amplification refractory mutation system-polymerase chain reaction (ARMS-PCR) were used to detect the <i>EGFR</i> mutation status. The Idylla™ system results and ARMS-PCR results were compared. When results were discordant, the Idylla™ system would be retested, and a third analysis method was performed to confirm test results when possible.</p><p><strong>Results: </strong>Among the 220 valid results of the Idylla™ system, the Idylla™ identified <i>EGFR</i> mutations in 109 cases with an incidence of mutation of 49.55%. The Idylla™ assay results were in complete agreement with the results of the reference methods for 207 cases, yielding an overall accordance of 94.09% (207/220, 95% CI, 90.11%-96.82%). Consequently, the overall concordance with routine reference methods, including further analysis, was found to be 96.81% (213/220, 95% CI: 93.28%-98.60%), with a negative percentage agreement of 97.3% (108/111, 95% CI: 91.72%-99.30%) and a positive percentage agreement of 96.33% (105/109, 95% CI: 90.32%-98.81%).</p><p><strong>Conclusion: </strong>The Idylla™ system is a rapid and effective method that enables sensitive and reliable detection of <i>EGFR</i> mutations in FFPE samples of NSCLC patients, with minimal molecular expertise or infrastructure.</p>\",\"PeriodicalId\":8228,\"journal\":{\"name\":\"Annals of clinical and laboratory science\",\"volume\":\"54 5\",\"pages\":\"652-660\"},\"PeriodicalIF\":1.1000,\"publicationDate\":\"2024-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Annals of clinical and laboratory science\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"MEDICAL LABORATORY TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Annals of clinical and laboratory science","FirstCategoryId":"3","ListUrlMain":"","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
Application of IdyllaTM System for Rapid Evaluation of EGFR Mutation Status in Formalin-Fixed and Paraffin-Embedded Samples of Non-Small Cell Lung Cancer.
Objective: In approximately 80% of the patients with advanced non-small cell lung cancer (NSCLC), the only samples available are cytological material or a limited amount of tissue specimens. Therefore, we aimed to explore the effect of the Idylla™ system for rapid evaluation of epidermal growth factor receptor (EGFR) mutation status in formalin-fixed and paraffin-embedded (FFPE) samples of NSCLC patients.
Methods: A total of 221 archived FFPE NSCLC tissue specimens were included in this study. Idylla™ system and amplification refractory mutation system-polymerase chain reaction (ARMS-PCR) were used to detect the EGFR mutation status. The Idylla™ system results and ARMS-PCR results were compared. When results were discordant, the Idylla™ system would be retested, and a third analysis method was performed to confirm test results when possible.
Results: Among the 220 valid results of the Idylla™ system, the Idylla™ identified EGFR mutations in 109 cases with an incidence of mutation of 49.55%. The Idylla™ assay results were in complete agreement with the results of the reference methods for 207 cases, yielding an overall accordance of 94.09% (207/220, 95% CI, 90.11%-96.82%). Consequently, the overall concordance with routine reference methods, including further analysis, was found to be 96.81% (213/220, 95% CI: 93.28%-98.60%), with a negative percentage agreement of 97.3% (108/111, 95% CI: 91.72%-99.30%) and a positive percentage agreement of 96.33% (105/109, 95% CI: 90.32%-98.81%).
Conclusion: The Idylla™ system is a rapid and effective method that enables sensitive and reliable detection of EGFR mutations in FFPE samples of NSCLC patients, with minimal molecular expertise or infrastructure.
期刊介绍:
The Annals of Clinical & Laboratory Science
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