关键词: 液相色谱串联质谱, 临床实验室, 应用现状

Abstract:

Objective To investigate the application status of liquid chromatography-tandem mass spectrometry （LC-MS/MS） in clinical laboratories in Shanghai. Methods The self-built questionnaire was used to investigate the clinical mass spectrometry laboratories in Shanghai，and the professional staff，equipment，project development and operation status was analyzed. Results LC-MS/MS was performed in 17 medical institutions in Shanghai，including 16 Grade 3 hospitals and 1 Grade 2 hospital. There were 14 general hospitals and 3 specialized hospitals. Laboratory-related technical personnel were mainly medical laboratory professionals，69.6% engaged in mass spectrometry for 1 to 5 years，54.3% of moderate level of professional titles. The 16 of 17 laboratories calibrated mass spectrometer once or twice a year，and 15 laboratories performed maintenance once or twice a year. The 82.4% of mass spectrometers used had an annual failure frequency of 1 to 3 times，and the supporting liquid chromatography system had an annual failure frequency of 1 to 5 times. The number of liquid chromatography-tandem mass spectrometry projects carried out by 3 laboratories reached 66，84 and 100，respectively，the number carried out by the other laboratories was ≤33，and the determination projects focused on vitamins，endocrine hormones and therapeutic drug monitoring （TDM）. All the laboratories carried out internal quality control according to the requirements，and the quality control materials used were mostly commercial quality control materials. In the TDM projects of hormones，vitamins and antibiotics，42.9%，25.0% and 50.0% of laboratories used homemade quality control materials for internal quality control. One laboratory used the Westgard sigma rule for internal quality control analysis，and the other laboratories chose the Westgard multi-rule quality control procedure. For projects with an inter-laboratory quality assessment，each laboratory completed the result comparison in the inter-laboratory quality assessment. For projects without an inter-laboratory quality assessment，laboratories regularly conducted inter-laboratory comparisons. Conclusions he application of LC-MS/MS in Shanghai is still in its initial stage. Personnel training and quality assurance measures should be strengthened to improve the determination quality.

Key words: Liquid chromatography-tandem mass spectrometry, Clinical laboratory, Application status