Kara Lynch (Presenter)
University of California San Francisco
Authorship: Kara L. Lynch
University of California San Francisco
| Short Abstract Until recently, there existed minimal regulatory guidance on the use of LC-MS for clinical diagnostics. The Clinical and Laboratory Standards Institute (CLSI) has now presented a standardized approach for LC-MS assay development, verification and quality assurance monitoring in its new guidance document, CLSI C62-A. This talk will review the recommendations presented in this document for quality assurance monitoring of LC-MS quantitative assays. Consensus recommendations set forth by other regulatory agencies will also be reviewed and compared. |
Long Abstract
Until recently, there existed minimal regulatory guidance on the use of LC-MS for clinical diagnostics. The Clinical and Laboratory Standards Institute (CLSI) has now presented a standardized approach for LC-MS assay development, verification and quality assurance monitoring in its new guidance document, CLSI C62-A. This talk will review the recommendations presented in this document for quality assurance monitoring of LC-MS quantitative assays. Consensus recommendations set forth by other regulatory agencies will also be reviewed and compared.
References & Acknowledgements:
| Description | Y/N | Source |
| Grants | no | |
| Salary | yes | Pain and Rehabilitative Consultants Medical Group |
| Board Member | no | |
| Stock | no | |
| Expenses | no |
IP Royalty: no
| Planning to mention or discuss specific products or technology of the company(ies) listed above: | no |