Quality management requirements of clinical mass spectrometry method in the United States
10.3760/cma.j.cn114452-20220320-00161
- VernacularTitle:美国临床实验室对临床质谱方法的质量管理要求
- Author:
William WU
1
Author Information
1. Quest Diagnostics Nichols Institute，Chantilly，VA 20151，美国
- Keywords:
Mass spectrometry;
Liquid chromatography;
Quality management
- From:
Chinese Journal of Laboratory Medicine
2022;45(11):1104-1108
- CountryChina
- Language:Chinese
-
Abstract:
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 among labs.
