快速檢驗的發展趨勢

The future development of point-of-care testing

蔡婉慧(Un-Wai Choi)

指導教授 ： 蔡淦仁 ； 羅永明

中山醫學大學/醫學科技學院/醫學檢驗暨生物技術學系碩士班/碩士(2018年)

摘要

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。

關鍵字

快速檢驗 ； POCT ； 發展趨勢 ； 認證法規 ； 品質管理

並列摘要

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.

並列關鍵字

Point-of-care testing ； POCT ； development ； trend ； regulations ； quality management ； application

參考文獻

1. ISO. ISO 22870:2016. point-of-care testing(POCT) -- requirements for quality and competence. 2016.

2. Shephard, M. A Practical Guide to Global Point-of-Care Testing: Csiro Publishing. 2016.

3. Junker, R., Schlebusch, H., & Luppa, P. B. Point-of-care testing in hospitals and primary care. Deutsches Ärzteblatt International, 107(33):561. 2010.

4. Gill, J. P., & Shephard, M. D. The conduct of quality control and quality assurance testing for PoCT outside the laboratory. The Clinical Biochemist Reviews, 31(3):85. 2010.

5. Price, C. P. Regular review: Point of care testing. BMJ: British Medical Journal, 322(7297):1285. 2001.