DATE: September 18, 2018
TIME: 9:00AM PDT

LC-MS/MS has been increasingly adopted by clinical laboratories due to the potential it has for increased sensitivity and specificity over more commonly used analytical techniques.  However, implementation can be daunting due to the complex nature of the instrumentation and the added burden of development and validation of methods that must be undertaken by the laboratory if they are laboratory developed tests (LDTs).  This presentation will discuss best practices for validating clinical LC-MS/MS methods including writing a validation plan, pre-validation recommendations and post-validation monitoring.

Learning Objectives:

• Write a validation plan and pre-validation recommendations
• Discuss best practices and solutions for determining common validation parameters such as precision, linearity, matrix effects, extraction recovery and accuracy

• Write a validation summary and establish LC-MS/MS data review and reporting criteria