臺灣博碩士論文加值系統

目的：瞭解快速檢驗的發展歷程，以及快速檢驗在預防醫學及臨床醫療上的應用，歸納整理並推測未來發展趨向。方法：以文獻回顧方式，整理快速檢驗的背景與發展趨向、以及技術的演進，推測其未來可能發展的趨勢。結論：透過了解快速檢驗的背景、過去及現今發展趨勢，包括目前認證法規、不同領域中快速檢驗所擔當的角色及其重要性、快速檢驗的品質管理等相關內容，以得知現在快速檢驗仍有待改善及進步的空間，包括技術、設備、品質管理及擴展應用層面，期望將來各地政府應有相關法規及指導原則，譬如建立快速檢驗的區域性委員會，以管理監控及推進快速檢驗的使用及發展。

Objectives: To understand the history and development of Point-of-care testing (POCT) products currently applied to health services, in order to rationalize and make assumptions for the future trend of using POCT and their future developments. Methods: Using literature review to identify the unique backgrounds and technological availabilities related to current POCT developments, to conclude and predict the future trend of POCT products and their roles in clinical applications. Conclusions: By comprehending the available information for POCT, five different aspects were discussed for each POCT included in this thesis review, there are: 1) backgrounds for POCT products; 2) historical and current development trends of POCT products; 3) current requirements for certifications and regulations for POCT products; 4) roles of POCT products in different areas; and 5) quality management of using POCT products. Based on these review studies, we concluded that POCT products are user friendly, cost effectively, and extremely versatile in their applications health services. Since the technologies continuously input to improve their accuracies and flexibilities, alone with manageable quality control, more applicable potentials are expected for the future developments of POCT products. However, establishing effective regulations, guidelines and controls to guarantee the usages of POCT products will be necessary.

目錄
中文摘要 i
英文摘要 ii
目錄 iii
表目錄 iv
1. POCT背景 1
1.1 定義 1
1.2 應用的領域 2
1.3 儀器分類 2
1.4 POCT與中央實驗室之對比 3
1.5 目前市面上的POCT 5
2. POCT發展 7
2.1 歷史發展分析 7
2.1.1 總體發展 7
2.2 現代技術及項目的發展演進 8
2.2.1 SBDAs技術的發展 8
2.2.1.1 SBDAs背景 8
2.2.1.2 近年發展 9
2.2.2 紙基分析設備 10
2.2.2.1 定義及特點 10
2.2.2.2 發展 11
2.2.2.2.1 近年發展 12
2.2.3 血糖儀的發展史 13
2.2.3.1 CGM 15
2.2.3.2 近年發展 17
2.3 現時POCT的認證法規 18
2.3.1 現時POCT的法規及地區文件 18
2.3.2 現時POCT的國際標準 22
2.3.3 現時POCT的認證機構 23
3. 討論POCT未來發展趨勢 24
3.1 現今的角色及重要性 24
3.1.1 醫院的角色及重要性 24
3.1.2 在社區護理的角色及重要性 26
3.1.2.1 HIV快速測試在社區的重要性 27
3.1.2.1.1 澳門地區 27
3.1.2.1.2 鄰近地區 28
3.1.2.1.3 注意事項 29
3.1.2.1.4 HIV快速檢驗近年發展 29
3.1.3 在災情救援的角色及重要性 30
3.1.4 在食品安全的角色及重要性 30
3.1.5 在藥物濫用的角色及重要性 31
3.2 品質管理部分 31
3.2.1 IQC及EQA 32
3.2.1.1 分析前 33
3.2.1.2 風險管理 34
3.3 POCT未來發展趨勢的推測及展望 35
4. 總結 37
5. 參考資料 38
6. 附錄 50

表目錄
表1. POCT與中央實驗室檢驗的詳細比較 3
表2.市面上POCT檢測項目 5
表3. 1956-2013年血糖生物感測器的發展 14
表4. 各國家發布POCT相關指引文件 20
表5. 文中簡稱涉及的中英名稱對照表 38
表6. 文中涉及的檢驗項目中英文簡稱名稱對照表 40

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