NOV 02, 2016 7:30 AM PDT

FDA and Mass Spec Tests for Clinical Labs

Speaker

Abstract

Most of the tests performed for patient care use automated colorimetric and immunoassay methods in the clinical laboratories. Clinical labs are regulated by CLIA and are routinely inspected by the College of American Pathologists. In local hospital clinical labs, all the machines and methods used are FDA cleared. There are numerous tests used in clinical practice which are not FDA cleared and have been developed by large reference laboratories. The methods used for these tests rely on technologies used for genomics, metabolomics, and proteomics areas of research. Mass Spectrometry is a powerful tool that is now commonly used in clinical laboratories and helps in making diagnosis of various diseases. Very few mass spec methods have been cleared by the FDA. The presenter recently attended a workshop held by the FDA and will present his experience and interactions in the workshop.


Show Resources
You May Also Like
JUN 21, 2022 6:00 AM PDT
JUN 21, 2022 6:00 AM PDT
Date: June 21, 2022 Time: 6:00am (PDT), 9:00am (EDT), 3:00pm (CEST) The global understanding and practice of medicine is currently undergoing a revolutionary change. This shift to precision...
C.E. CREDITS
Date: October 25, 2022 Time: 9:00am (PST), 12:00pm (EST), 6:00pm (CEST) Candida auris is a multi-drug resistant yeast that continues to be a global threat for infection and transmission in h...
JUN 28, 2022 7:00 AM PDT
JUN 28, 2022 7:00 AM PDT
Date: June 28, 2022 Time: 3:00pm (BST), 4:00pm (CET), 9:00am (CST), 7am (PST) Light-sheet microscopy is an extremely versatile imaging technique with a vast range of implementations that are...
SEP 13, 2022 8:00 AM PDT
SEP 13, 2022 8:00 AM PDT
Date: September 13, 2022 Time: 8:00am (PDT), 11:00am (EDT), 5:00pm (CEST) Preparedness against pandemic diseases demands rapid-response vaccine technology and ready-to-use analytical methods...
OCT 12, 2022 9:00 AM PDT
C.E. CREDITS
OCT 12, 2022 9:00 AM PDT
Date: October 12, 2022 Time: 9:00am (PDT), 12:00pm (EDT), 6:00pm (CEST) The microbiome of every food product is incredibly diverse and can include everything from innocuous background flora...
OCT 13, 2022 9:00 AM +08
OCT 13, 2022 9:00 AM +08
First Broadcast: Date: October 12, 2022 Time: 8:00am PDT, 11:00am EDT Second Broadcast: Date: October 12, 2022 Time: 9:00am SGT The new Embedded CryoSPARC Live, now fully integrated with t...
NOV 02, 2016 7:30 AM PDT

FDA and Mass Spec Tests for Clinical Labs



Show Resources
Loading Comments...
Show Resources