Impact of the loss of Laboratory Developed Mass Spectrometry testing at a major academic medical center.

Journal of mass spectrometry and advances in the clinical lab（2023）

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摘要

Barriers that discourage laboratories from developing in-house testing, particularly in the absence of FDA-cleared alternatives, can be expected to have a detrimental effect on patient care and hospital finances.

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关键词

CLIA,CLIA, clinical laboratory improvement amendments,Cyclo A, cyclosporine A,EUA, emergency use authorization,FDA,FDA, food and drug administration,ISD, immunosuppressant drug monitoring,IVD, In-vitro diagnostic,LCMS, liquid chromatography mass spectrometry,LDT,LDT, laboratory developed test,Laboratory developed test,MS, mass spectrometry,TAT, turnaround time,TDM, therapeutic drug monitoring,VALID Act,VALID, verifying accurate leading-edge IVCT development

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