用于尿液有机酸检测的气相色谱-质谱联用仪年度维护保养后的校准及性能验证
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摘要
目的建立用于尿液有机酸检测的GCMS-QP 2010 Ultra气相色谱-质谱联用仪年度维护保养后校准及性能验证的方法,以确保检测系统性能持续满足检测需要。方法按照设备制造商要求及《台式气相色谱-质谱联用仪校准规范》对气相色谱质谱联用仪年度维护后进行校准;按照CNAS-CL02-A003《医学实验室质量和能力认可准则在临床化学检验领域的应用说明》对维护保养后的气相色谱-质谱联用仪分析性能进行验证。结果质量范围、质量准确性、分辨力、信噪比、重复性的校准结果均符合要求;室内质控物检测结果在控,留样再测结果一致。结论摸索出了用于尿液有机酸检测的气相色谱-质谱联用仪年度维护保养后的校准及性能验证方法,有利于为临床提供准确可靠的尿液有机酸检测结果。
Objective To establish a method of calibration and performance verification of the GCMS-QP 2010 Ultra gas chromatography-mass spectrometer for urine organic acid detection after annual maintenance, so as to ensure that the performance of the detection system can continuously meet the detection needs. Methods According to the requirements of the equipment manufacturer and the Calibration Specifications for Benchtop Gas Chromatography-Mass Spectrometer, the gas chromatography-mass spectrometer was calibrated after annual maintenance. According to the CNAS-CL02-A003 Guidance on the Application of Accreditation Criteria for the Medical Laboratory Quality and Competence in the Field of Clinical Chemistry, the analytical performance of the maintained gas chromatography-mass spectrometer was validated. Results The calibration results of quality range, quality accuracy, resolution, signal-to-noise ratio and repeatability were all met the requirements. The detection results of internal quality control materials were under control, and the results of retained samples kept unchanged. Conclusion The calibration and performance verification method of the gas chromatography-mass spectrometer for urine organic acid detection after annual maintenance is established successfully, which is of importance for providing accurate and reliable results of urine organic acid.
Objective To establish a method of calibration and performance verification of the GCMS-QP 2010 Ultra gas chromatography-mass spectrometer for urine organic acid detection after annual maintenance, so as to ensure that the performance of the detection system can continuously meet the detection needs. Methods According to the requirements of the equipment manufacturer and the Calibration Specifications for Benchtop Gas Chromatography-Mass Spectrometer, the gas chromatography-mass spectrometer was calibrated after annual maintenance. According to the CNAS-CL02-A003 Guidance on the Application of Accreditation Criteria for the Medical Laboratory Quality and Competence in the Field of Clinical Chemistry, the analytical performance of the maintained gas chromatography-mass spectrometer was validated. Results The calibration results of quality range, quality accuracy, resolution, signal-to-noise ratio and repeatability were all met the requirements. The detection results of internal quality control materials were under control, and the results of retained samples kept unchanged. Conclusion The calibration and performance verification method of the gas chromatography-mass spectrometer for urine organic acid detection after annual maintenance is established successfully, which is of importance for providing accurate and reliable results of urine organic acid.
引文
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[2]王志伟.临床实验室仪器设备的校准与校准验证[J].中国医疗设备,2012,27(6):66-68.
[3]古海锋,郭洪祝,厉进忠,等.药品检验用仪器设备性能验证指导原则和技术标准的探讨[J].中国药事,2014,28(7):710-714.
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