微生物质谱鉴定仪安全有效性评价

Evaluation of the Safety and Effectiveness of the Microbial Mass Spectrometer

微生物质谱鉴定仪运用的基质辅助激光解吸电离飞行时间质谱(MALDI-TOF-MS)技术应用于临床微生物鉴定操作,极大地提高了临床微生物的鉴定效率。文章从医疗器械技术审评角度对微生物质谱鉴定仪安全有效性进行评价。在综述资料、研究资料、临床评价、说明书方面提出审评关注点,以期对该类产品注册申报和技术审评有所帮助。

Matrix assisted laser desorption ionization time-of-flight mass spectrometry(MALDI-TOF-MS)has greatly improved the efficiency of clinical microbiological identification.In this paper,the safety and effectiveness of microbial mass spectrometer were evaluated from the perspective of medical device technology evaluation.In order to help the registration application and technical evaluation of such products,the focus of review is put forward in terms of review data,research data,clinical evaluation and instructions.