LC-MS/MS生物样品分析方法的应用与评价

Application and Evaluation of Some Validated LC-MS/MS Bioanalytical Methods Used in Routine Sample Analysis

选择9个已验证的LC-MS/MS方法,从分析批、试验样品再分析(ISR)角度,对生物样品分析方法在实际样品检测应用过程中的QC样品合格率、ISR偏差进行分析和评价,以期发现潜在问题,建立合适评价方法,为日后方法建立、应用和质量管理及质量控制提供依据。结果表明,通过精心实验设计、严格过程管理、科学方法验证的生物分析方法在实际应用中的偏差是可控的。从质量管理和质量控制的角度,应重视生物分析方法在实际应用时的QC样品合格率、ISR样品的合格率和偏差平均值。对于合格率低或偏差大的方法应积极探究原因。

Nine validated LC-MS/MS methods were selected to analyze and evaluate the rate of passed QC samples and the incurred samples reanalysis(ISR) deviation in respect of analytical batches and ISR from routine sample analysis study. It is expected to avoid potential risks, establish suitable evaluation methods, and provide evidences for the analytical method establishment, application, quality management and quality control in the future. The results showed that the deviations from a bioanalytical method application were controllable with careful experiment design, strict process management and scientific method verification. From the perspective of quality management and quality control, attentions should be paid to the rate of passed QC samples, the rate of passed ISR samples, and the average deviation in a practical application of biological analysis method. Sources resulting in some methods with low passed rate or large deviation should be proactively investigated.