Quantitative tandem mass spectrometry in the clinical laboratory: Regulation and opportunity for validation of laboratory developed tests.
J Mass Spectrom Adv Clin Lab
; 28: 82-90, 2023 Apr.
Article
en En
| MEDLINE
| ID: mdl-36937811
AACC, American Association for Clinical Chemistry; AMP, Association for Molecular Pathology; CAP, College of Amercian Pathologists; CLIA'88, Clinical Laboratory Improvement Amendments of 1988; CLSI, Clinical Laboratory Standards Institute; CMS, Centers for Medicare & Medicaid Services; CoA, Certificate of Analysis; FDA, Federal Drug Administration; FFDCA, Federal Food, Drug and Cosmetics Act; GCMS, Gas Chromatography-Mass Spectrometry; HELP, U.S. Senate Committee on Health, Education, Labor & Pensions; IA, Immunoassay(s); IVD, In-vitro Device; LC-MSMS, Liquid Chromatography-Tandem Mass Spectrometry; LDT, Laboratory Developed Test; Laboratory diagnosis; Liquid chromatography-tandem mass spectrometry; MDA, Medical Device Amendments; MLS, Medical Laboratory Scientist(s); MSACL, Mass Spectrometry & Advances in the Clinical Laboratory; Method validation; QntLCMS-LDT, Quantitative LC-MSMS LDT; SOP, Standard Operating Procedure; VALID, Verifying Accurate Leading-edge IVCT Development Act of 2021; VITAL, Verified Innovative Testing in American Laboratories Act of 2021
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Tipo de estudio:
Guideline
Idioma:
En
Revista:
J Mass Spectrom Adv Clin Lab
Año:
2023
Tipo del documento:
Article
País de afiliación:
Estados Unidos
Pais de publicación:
Países Bajos