摘要
目的:建立医用液相色谱-质谱联用仪关键指标性能评价方法,为临床检验提供参考。方法:在对国内外8家企业生产的11个不同型号的液相色谱-质谱联用仪的结构和性能进行调研的基础上,建立仪器对液相色谱的泵流速准确度、自动进样器与色谱柱恒温箱温度准确度、自动进样器线性、质谱部分的质量准确性和质量分辨率、扫描速度、系统灵敏度、精密度和携带污染等性能指标的评价方法,并对11台仪器进行测试。结果:在11台不同型号的液相色谱-质谱联用仪中有9台仪器泵流速准确度在±1.0%范围内;所有仪器自动进样器与色谱柱恒温箱温度准确度均在±2℃范围内;有7台仪器自动进样器线性回归系数≥0.990;所有仪器质量准确性实测值与理论质荷比的误差在±0.2 u范围内,半峰宽可调节<0.8 u;扫描速度均>1000 u/s;灵敏度测定的正离子模式为0.42/pg~179/pg,负离子模式为0.80/pg~60/pg,差异较大;9台仪器色谱峰面积精密度变异系数(CV)为1.50%~7.35%,1台仪器CV>10%;保留时间的标准偏差(SD)均<0.02;8台仪器携带污染率<0.05%,1台仪器携带污染率>0.10%。结论:通过测试证明,建立的医用液相色谱-质谱联用仪关键指标的性能评价方法具有适用性和可操作性。
Objective:To establish a method of the performance evaluation of key indicators of medical liquid chromatography-mass spectrometer so as to provide reference for clinical testing.Methods:The structure and performance of 11 different types of liquid chromatography-mass spectrometer manufactured by 8 companies at home and abroad were investigated and tested,and then,the evaluation methods of performance indicators of accuracy of pump flow rate,temperature accuracy of automatic sampler and chromatographic column incubator,linearity of automatic sampler of the liquid chromatography,and the mass accuracy and mass resolution,scanning speed of the mass spectrometry,and the sensitivity,precision and carry-over of system were established.And these methods were used to test the 11 instruments.Results:The accuracies of pump flow rates of 9 instruments in 11 instruments were within±1.0%.The temperature accuracies of automatic sampler and chromatographic column incubator of all instruments were within±2℃.The linear regression coefficients of automatic sampler of 7 types of instruments were greater than 0.990.The errors between the measured value and the theoretical mass load ratio were within±0.2u in all instruments.And the half peak widths could be adjusted of all instruments were less than 0.8u.The scanning speeds of them were greater than 1000u/s,and the sensitivities of them were measured by positive ion mode were between 0.42/pg and 179/pg,and those by negative ion mode were between 0.80/pg and 60 pg,with great difference.The coefficient of variations(CVs)of peak area precisions of 9 instruments were 1.50%-7.35%,and that of 1instrument was larger than 10%.The standard deviation(SD)of retention time was less than 0.02,and carry-overs of 8 instruments was less than 0.05%,and that of 1 instrument exceed 0.10%.Conclusion:The tests indicate that the established methods of performance evaluation of key indicators of liquid chromatography-mass spectrometer have applicability and practicability.
作者
彭絮
邹迎曙
李胜民
代蕾颖
杨忠
孙雪晴
宋伟
于泳
PENG Xu;ZOU Ying-shu;LI Sheng-min(In Vitro Diagnosis Room,Beijing Institute of Medical Device Testing,Key Laboratory for Qual ity Evaluation of In Vitro Diagnostic Reagent of National Medical Products Administration,Beijing Key Laboratory of Me dical Device Testing and Safety Evaluation,Beijing 101111,China;不详)
出处
《中国医学装备》
2022年第5期7-12,共6页
China Medical Equipment
基金
国家重点研发计划(2021YFC2401100)“医用高效液相色谱三重四极杆质谱联用仪研发及产业化”。
关键词
液相色谱-质谱联用仪
性能评价
方法学
Liquid chromatography-mass spectrometer
Performance evaluation
Methodology
