NEW ST102 How to Validate a New Test
4:30–5:30 pm
1 CME/CE CREDIT
Laboratories must validate the technical performance of tests before use on patient samples; but with laboratory testing conducted in a variety of clinical settings—from core labs to physician office and mobile vehicles—method validation can be challenging. Newer point-of-care devices and automated instrumentation are also challenging to validate, given the spectrum of different methodologies, device operation, and clinical applications of the test results. This course reviews regulatory requirements for technical performance (precision, accuracy, reportable range, reference intervals, and other specifications) and offers practical suggestions to validate tests. Using real-world examples, faculty will highlight the importance of method validation to patient care and clinical consultation.
You will learn to:
- Explain the CLIA ’88 requirements for method validation
- Discuss the nuances of test validation for newer methods like point-of-care testing and automated instrumentation
- Develop and interpret experiments to document validation of technical performance based on CLSI guidelines
Faculty
James H. Nichols, PhD