Innovators Circle: Designing Robust Specimen Stability Studies

Reliable laboratory results depend on understanding how specimen integrity changes over time. This session will provide a practical overview of designing and validating specimen stability studies, grounded in the MDIC Specimen Stability Framework.

Experts from industry, regulatory agencies, and clinical laboratories will highlight key factors influencing stability, compare study design approaches, and discuss how to establish analyte appropriate acceptance criteria. The team will also address real world challenges such as testing around medical decision limits, evaluating urine metabolite formation, extending stability claims, and verifying manufacturer claims when resources are limited.

Attendees will gain clear, actionable guidance for applying the MDIC framework to strengthen their stability study strategies and support high quality diagnostic performance.