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歷 年 稿 件 內 容
 
*類別： D組-分子醫學
* 姓名： 劉原智
投稿種類： 壁報
*中文投稿標題： 具有內部品管機制之HER2乳癌分子診斷試劑的臨床評估
*中文作者姓名列： 許琳岡 1，劉原智 1，2，徐武琦 1，葉育銘 1
*中文服務單位： 1，普生股份有限公司 2，居禮股份有限公司
*英文投稿標題： Clinical Evaluation of HER2 Molecular Diagnostic Assay with Internal Quality Controls in Breast Cancer
*英文作者姓名列： Lin-Kang Hsu 1, Yuan-Zhi Liu 1, 2, Wu-Chi Hsu 1, Yu-Ming Yeh 1
*英文服務單位： 1, General Biologicals Corporation, 2, Curiemed Corporation
* 投稿摘要： Determination of HER2 status before taking therapeutic regimens plays an essential role in breast cancer. Immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) are currently working assays for HER2 testing. With the advantages of cost-effectiveness and high accuracy for IHC and FISH respectively, these two assays have been recommended as the routinely-used diagnostic tool. However, several studies has been reported that false signals and lab-to-lab variations are major unsolved issues for HER2 testing. Moreover, both IHC and FISH assays do not have the internal quality control mechanism, which might be the root-causes of the issues that we’re facing. Here, we developed and evaluated a novel HER2 testing assay with built-in internal quality control mechanisms by the principle of multiplex real-time PCR. Fifty FFPE samples were collected and analyzed for the evaluation. The result showed that the agreement between the developed assay and FDA certified FISH assay is over 90%, suggesting the developed Real-Time PCR is accurate and reliable for HER2 testing. Furthermore, the quality of FFPE samples can be distinguished simultaneously, which can prevent false signals or lab-to-lab variations that resulted from poor qualified samples. To sum up, the clinical efficacy of the developed HER2 molecular diagnostic assay shows great quality control ability and high analytical consistency with current assays for HER2 testing.
*關鍵字1 ： HER2
*關鍵字2 ： Quality control
*關鍵字3 ： Molecular diagnosis
*關鍵字4 ： NA
*關鍵字5 ： NA
* 服務機關：
* 第一作者： 許琳岡
* 身分字號： *****27353
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