美国临床实验室对临床质谱方法的质量管理要求

Quality managementrequirements ofclinicalmass spectrometrymethod intheUnited States

自从液相色谱串联质谱仪器问世以来,质谱技术在临床实验室中备受欢迎。由于绝大多数的临床质谱方法是未经美国食品药品监督管理局批准的实验室自建方法,为了确保检测结果的可靠性,对临床质谱方法进行质量管理,显得至关重要。美国临床和实验室标准化协会C62-A指南是一个基于对临床质谱方法的高标准质量管理指导文件。本文以美国一个认证的临床质谱实验室为案例,阐述了其临床质谱方法设计开发、验证以及日常运营的质量管理要求。临床质谱方法质量管理的一致性和标准化不仅是实验室间质谱检测结果互认的必要保证,也是难点和挑战。

Mass spectrometry technique has been very well received in the clinical lab since the commercial liquid chromatography tandem mass spectrometry instrument became available.As majority of the clinical mass spectrometry assays are lab developed tests without Food and Drug Administration clearance,proper quality management of a clinical mass spectrometry method is critical to ensure reliable testing results.Clinical and Laboratory Standards Institute guideline C62-A,a high standard and best practice guidance,has been published to address the quality management requirements of a clinical mass spectrometry method.This review describes quality management requirements of a mass spectrometry method during the development,validation,and daily operation in an accredited clinical lab in the United States.The consistency and standardization of quality management requirements of clinical mass spectrometry methods are not only the foundation of comparability of testing results,but remain as difficulties and challenges amonglabs.