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

Judith A Stone1, J Grace van der Gugten2

  • 1Department of Clinical Laboratories, University of California San Francisco Health, San Francisco, CA, United States.

Journal of Mass Spectrometry and Advances in the Clinical Lab
|March 20, 2023
PubMed

Keywords:
AACC, American Association for Clinical ChemistryAMP, Association for Molecular PathologyCAP, College of Amercian PathologistsCLIA’88, Clinical Laboratory Improvement Amendments of 1988CLSI, Clinical Laboratory Standards InstituteCMS, Centers for Medicare & Medicaid ServicesCoA, Certificate of AnalysisFDA, Federal Drug AdministrationFFDCA, Federal Food, Drug and Cosmetics ActGC–MS, Gas Chromatography-Mass SpectrometryHELP, U.S. Senate Committee on Health, Education, Labor & PensionsIA, Immunoassay(s)IVD, In-vitro DeviceLC-MSMS, Liquid Chromatography-Tandem Mass SpectrometryLDT, Laboratory Developed TestLaboratory diagnosisLiquid chromatography-tandem mass spectrometryMDA, Medical Device AmendmentsMLS, Medical Laboratory Scientist(s)MSACL, Mass Spectrometry & Advances in the Clinical LaboratoryMethod validationQntLCMS-LDT, Quantitative LC-MSMS LDTSOP, Standard Operating ProcedureVALID, Verifying Accurate Leading-edge IVCT Development Act of 2021VITAL, Verified Innovative Testing in American Laboratories Act of 2021

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