氨基酸及肉碱非衍生化串联质谱法检测系统的性能验证

目的按照ISO15189-2012《医学实验室质量和能力的要求》对Waters公司ACQUITY TQD串联质谱仪及其配套试剂、PerkinElmer公司NeoBaseTM Non-derivatized MSMS kit在测定氨基酸和肉碱方面进行性能验证。方法按照美国临床实验室标准化协会指南文件EP15-A2《用户对精密度和准确度性能的核实实验——批准指南》提供的方法,对检测系统进行正确度和精密度验证;按照卫生部行业标准WS/T408-2012《临床化学设备线性评价指南》提供的方法,对其进行线性范围验证。结果 6种氨基酸和7种肉碱的相对偏倚为0.13%~11.34%,均小于1/2允许总误差;批内精密度为0.55%~4.78%,均小于1/4允许总误差;期间精密度除缬氨酸低水平外,为2.52%~7.95%,小于1/3允许总误差;瓜氨酸、苯丙氨酸、游离肉碱在厂家给出的线性范围内呈一阶线性,缬氨酸呈二阶线性,其余呈三阶线性。结论氨基酸及肉碱非衍生化串联质谱法配套检测系统的性能特征验证通过,可按照常规临床化学检测系统进行管理和要求。

Verification of the performance of non-derivatized tandem mass spectrometry method in detecting the amino acids and carnitines

Objective To verify the performance of Waters ACQUITY TQD tandem mass spectrometry and PerkinElmer Neo‐BaseTM Non‐derivatized MSMS kit in detecting the amino acids and carnitines .And ISO15189 - 2012 Medical laboratories‐Require‐ments for quality and competence were the reference .Methods The accuracy and precision were verified according to Clinical and Laboratory Standards Institute documents ,EP15‐A2 User Verification of Performance for Precision and Trueness :Approved Guide‐line .The linear ranges were verified according to industry regulations of Ministry of Health ,WS/T 408‐2012 Linear Evaluation Guideline of Clinical Chemistry Equipment .Results The relative bias of 6 kinds of amino acids and 7 kinds of carnitines were from 0 .13% to 11 .34% ,which were all lower than 1/2 total error .The within precisions were from 0 .55% to 4 .78% ,which were all lower than 1/4 total error .And the intermediate precisions were from 2 .52% to 7 .95% ,which were all lower than 1/3 total error except valine low level .The linear ranges of citrulline ,phenylalanine and free carnitine were into first order linear within the linear range provided by the company .Valine was into second order linear and the rest amino acids were into third order linear . Conclusion The verification of performance of non‐derivatized tandem mass spectrometry method in detecting the amino acids and carnitines are passed ,and it can be managed and requested in accordance with the routine clinical chemical detection system .