Quantitative tandem mass spectrometry in the clinical laboratory: Regulation and opportunity for validation of laboratory developed tests.

Autor: Stone JA; Department of Clinical Laboratories, University of California San Francisco Health, San Francisco, CA, United States., van der Gugten JG; Office of the Chief Medical Examiner, Government of Alberta, Edmonton, AB, Canada.
Jazyk: angličtina
Zdroj: Journal of mass spectrometry and advances in the clinical lab [J Mass Spectrom Adv Clin Lab] 2023 Mar 05; Vol. 28, pp. 82-90. Date of Electronic Publication: 2023 Mar 05 (Print Publication: 2023).
DOI: 10.1016/j.jmsacl.2023.03.001
Abstrakt: 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.
Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(© 2023 THE AUTHORS.)
Databáze: MEDLINE
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