Want to learn more about the general elements of test validation—and which procedures do a good job of preserving validated test performance? Sign up for the July 26 morning short course at AACC’s Annual Meeting & Clinical Lab Expo, “Laboratory Director Boot Camp—What, When, Why, and How to Validate New Tests and Meet Regulatory Requirements” (191004).
Laboratory Director Boot Camp will provide attendees with the knowledge and skills to bring on new clinical laboratory tests in clinical chemistry, coagulation, and molecular diagnostics.
A great deal of confusion exists on this issue regarding linearity, calibration, calibration, verification, and matrix effect, said co-presenter Wieslaw Furmaga, MD, associate professor at the University of Texas Health Science Center at San Antonio, to CLN Stat. “We would like to define these elements in a simple and example-based format.”
Speakers will provide a general overview of the Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) regulatory requirements for implementing new tests. This includes conducting test validation, defining the analytical measurement range (as appropriate for quantitative assays), establishing reference ranges, and meeting the requirements for ongoing monitoring of test performance, including participation in proficiency testing.
Furmaga will discuss the basics of laboratory director boot camp: the “what, when, why, and hows” of validating new tests and meeting regulatory requirements. Joining him will be Keri Donaldson, MD, an assistant professor with Penn State Milton S. Hershey Medical Center’s Division of Clinical Pathology, who will moderate the session and discuss the “what, when, and hows” of method validation.
The goal is for attendees to gain a better understanding of the validation process for quantitative and qualitative tests, Furmaga said.
Laboratory boot camp is one of 13 short courses that are part of AACC University, offered on July 26, before the annual meeting kicks off officially. Attendees who don’t have the time or budget to attend the full conference can attend the short courses without paying the full meeting registration fee. As a bonus, AACC University attendees are welcome to attend the Sunday Plenary Session and the Opening Mixer.
Register online for Lab Director Boot Camp or other Annual Meeting sessions.