2011-05-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/643038摘要：本研究計畫提出前期『行政院國家科學技術發展基金補助計畫- e - Ab sensor 之臨床試驗暨商品化量產』開發之IVD「即時多功可攜式定點診斷用儀器: e- V Sensor」(Figure.1)之臨床試驗。e- V Sensor 其設計上整合了完整之微機電製程、微流道控制系統、電子電路機構、人機軟體操作介面、系統結構設計、專一性抗體感測晶片以及模組化之數位交換量測系統。其中，最有價值的核心技術在於改變抗體分子(特別是免疫球蛋白G, IgG)的蛋白質非導體特性，使抗體由非導體(non-conductor)變成半導體抗體(semiconductiveantibody)，進而突破非導體抗原待測物在電學量測上之瓶頸，因此能夠以電學理論將系統微小化及降低成本。在前期研究計畫中，e- V Sensor 已成功地小量組裝及製造生產。本發明 e- V Sensor 使用e- V Chip (Figure. 2)進行多項之抗原臨床測試，已經完成驗證全系統之性能與可靠度。接續於本計劃中，將執行人類乳突病毒(第16、18 型)、腸病毒71 型、流感病毒、肝腫瘤標記分子、肺癌非小細胞突變之上皮生長因子受體以及前抑鈣素等6 項臨床試驗。應用e- V Sensor 之臨床即時偵測試驗，臨床評估e- V Sensor其再現性、靈敏度、特異性、交互反應、潛在干擾物質影響等廣泛陽性檢體臨床資料，並與全球同類產品進行比對測試暨其差異性之再確認。我們期許將來可以發展成一項快速檢驗的診斷工具，除了可以降低醫療成本，同時可以有效縮短獲得檢驗結果的時間，應用在醫護最前線，早期診斷早期治療。<br> Abstract: In this project, the clinical trial of a compact and portable system, electronic Antibodysensor, IVD (e- V Sensor) is presented. The design of e- V Sensor incorporates a completeflow control system, a well-designed user controls, a multi-purpose sensing chip and amodular measuring system which is fully digitalized. The system can be miniaturized and costeffective via electronic metrology theorem by using a conductivity enhanced bio-linker andthe incorporation of the key features of semiconductive chip and affinity based antibodychip.The e- V Sensor has been successfully fabricated and manufactured in small quantity.The milestones of this project have been started with verifying the system’s performanceand reliability through the clinical tests including cancers and infective virus diseases for twomain patient population. In this project, we use e- V Sensor for conduct a prospective clinicalstudy of HPV、Enterovirus 71、Influenza Virus、LECT2、EGFR and Procalcitonin. We evaluatethe performance of e- V Sensor, including reproducibility, sensitivity, specificity, and crossreaction.The potential factors which may interfere with the results would be investigated.With such a real-time diagnostic technique, we hope that we can obtain information ofpatients in cost-saving and time-saving way and can give patients early treatment to reducethe complications and case-fatality rate and offer more individualized treatment for ourpatients.即時多功可攜式定點診斷用儀器電學半導體抗體臨床試驗人類乳突病毒腸病毒流感病毒肝腫瘤標記分子肺癌非小細胞突變之上皮生長因子受體前抑鈣素e- V sensorelectronicsemiconductive antibodyclinical trialsHPVEnterovirus 71Influenza VirusLECT2EGFRProcalcitonin