CLSI C62-A: A New Standard for Clinical Mass Spectrometry

[...]recently, there existed minimal guidance on the use of LC-MS for clinical diagnostics. An LDT is defined as an in vitro diagnostic test that is designed, manufactured, validated, and used within a single laboratory. [...]no 2 LC-MS methods for the same analyte are alike.

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Bibliographic Details
Published in:Clinical chemistry (Baltimore, Md.) Md.), 2016-01, Vol.62 (1), p.24-29
Main Author: Lynch, Kara L
Format: Article
Language:English
Subjects:
Accuracy
Clinical Laboratory Techniques - standards
Conflicts of interest
FDA approval
Humans
Immunoassay
Laboratories
Mass spectrometry
Mass Spectrometry - standards
Metabolic disorders
Methods
Quality standards
Scientific imaging
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Description
Summary:[...]recently, there existed minimal guidance on the use of LC-MS for clinical diagnostics. An LDT is defined as an in vitro diagnostic test that is designed, manufactured, validated, and used within a single laboratory. [...]no 2 LC-MS methods for the same analyte are alike.
ISSN:0009-9147
1530-8561
DOI:10.1373/clinchem.2015.238626