Capistran Briana A, Sisco Edward
National Institute of Standards and Technology, Gaithersburg, MD, USA.
Forensic Chem. 2024 Dec;41. doi: 10.1016/j.forc.2024.100609.
With the lack of standardized validation protocols across the forensic chemistry community, validation of instrumentation can be a challenging and time-consuming task. However, this process is crucial to understanding the associated capabilities and limitations, especially for nascent technologies. Rapid GC-MS is one such emerging analytical technique being increasingly implemented in forensic laboratories due to its fast and informative screening capabilities. However, a full validation for forensic samples has yet to be published since its debut. This work presents the results of a comprehensive validation of a rapid GC-MS system for seized drug screening through the assessment of nine components: selectivity, matrix effects, precision, accuracy, range, carryover/contamination, robustness, ruggedness, and stability. Single- and/or multi-compound test solutions of commonly encountered seized drug compounds were used to assess method and system performance. Results met the designated acceptance criteria for a majority of components. For example, retention time and mass spectral search score % RSDs were ≤ 10 % for precision and robustness studies. Limitations were identified for components that did not meet the acceptance criteria (., inability to differentiate some isomers). The study design is part of a larger validation package developed for rapid GC-MS that includes a validation plan and automated workbook. The template, available for adoption by laboratories, ultimately aims to reduce the barrier of implementation for rapid GC-MS technology.
由于法医化学领域缺乏标准化的验证方案,仪器验证可能是一项具有挑战性且耗时的任务。然而,这一过程对于了解相关的能力和局限性至关重要,尤其是对于新兴技术而言。快速气相色谱 - 质谱联用技术(Rapid GC-MS)就是这样一种新兴的分析技术,由于其快速且信息丰富的筛查能力,正越来越多地应用于法医实验室。然而,自其问世以来,尚未有针对法医样本的全面验证发表。这项工作通过评估九个方面:选择性、基质效应、精密度、准确度、范围、残留/污染、稳健性、耐用性和稳定性,展示了对用于查获毒品筛查的快速气相色谱 - 质谱联用系统进行全面验证的结果。使用常见的查获毒品化合物的单组分和/或多组分测试溶液来评估方法和系统性能。大多数方面的结果符合指定的验收标准。例如,在精密度和稳健性研究中,保留时间和质谱搜索得分的相对标准偏差(% RSD)≤ 10%。对于未达到验收标准的方面(如无法区分某些异构体)也确定了局限性。该研究设计是为快速气相色谱 - 质谱联用技术开发的更大验证包的一部分,其中包括验证计划和自动化工作簿。该模板可供实验室采用,最终目的是降低快速气相色谱 - 质谱联用技术的实施障碍。