Stone Judith A, van der Gugten J Grace
Department of Clinical Laboratories, University of California San Francisco Health, San Francisco, CA, United States.
Office of the Chief Medical Examiner, Government of Alberta, Edmonton, AB, Canada.
J Mass Spectrom Adv Clin Lab. 2023 Mar 5;28:82-90. doi: 10.1016/j.jmsacl.2023.03.001. eCollection 2023 Apr.
Tandem mass spectrometry is an important analytical tool for clinical laboratories, but tests developed and validated in-house (laboratory developed tests, or LDTs) require special consideration. In late 2022, the forecast for United States (U.S.) federal regulation of LDTs changed unexpectedly when the VALID Act was not passed by the U.S. Congress. This Act would have modified the Food and Drug Administration's (FDA's) role to increase regulatory oversight for LDT providers. In this revised context, we review optimization of quantitative mass spectrometry LDT validation and suggest avenues other than an additional FDA mandate to achieve uniform best practice. Common challenges, logistical barriers, and recommendations for easing the burden of best-quality quantitative mass spectrometry LDT method validation are discussed.
串联质谱分析法是临床实验室的一项重要分析工具，但内部开发并验证的检测方法（实验室开发的检测方法，即LDTs）需要特别考虑。2022年末，当《验证法案》未获美国国会通过时，美国联邦对LDTs的监管预测意外发生了变化。该法案本会改变美国食品药品监督管理局（FDA）的职责，以加强对LDTs供应商的监管。在这一修订后的背景下，我们回顾了定量质谱分析法LDT验证的优化，并提出了除FDA额外授权之外实现统一最佳实践的途径。讨论了常见挑战、后勤障碍以及减轻高质量定量质谱分析法LDT方法验证负担的建议。
