From bedside to bench: assay validation in the clinical genomics laboratory

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72 بار بازدید - 10 ماه پیش - Title: From bedside to bench:
Title: From bedside to bench: assay validation in the clinical genomics laboratory
Speaker: Jackie Roth, PhD, FACMG, of the University of Pennsylvania

Clinical laboratory assay validation is a complex process involving assessment of numerous analytic performance characteristics. Regulatory agencies, for example the College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA) in the United States, have set forth standards that must be upheld when validating an assay in the clinical laboratory. Prior to assay validation, however, the clinical utility and economic feasibility, among other factors, must be reviewed and determined to be favorable for a given institution. In certain situations, designing assays in collaboration with other laboratories may prove to be useful and cost-effective. This talk will review key aspects of assay validation and clinical laboratory regulations regarding assay validation. An example of a collaborative next-generation sequencing assay design and implementation will be shared.

https://www.antibodysociety.org/the-a...
10 ماه پیش در تاریخ 1402/07/05 منتشر شده است.
72 بـار بازدید شده
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