Standardized Framework for Specimen Stability Study Design and Analysis
Unlocking Best Practices for Specimen Stability in Diagnostic Testing
The Standardized Framework for Specimen Stability Study Design and Analysis is a groundbreaking resource developed by the Medical Device Innovation Consortium (MDIC) to advance the reliability and integrity of diagnostic testing. This comprehensive guide provides a harmonized approach for designing and validating specimen stability studies—critical for ensuring accurate results in clinical diagnostics.
The framework addresses the stability of whole blood, serum, and plasma specimens with medical devices, from defining minimum study design requirements through analysis, documentation and storage claims. It offers practical strategies for quantitative and qualitative assays, including statistical methodologies like linear regression and baseline comparison, and explores experimental designs such as classical and isochronous testing. With detailed considerations for risk assessment, workflow mapping, and regulatory considerations, this publication empowers developers to create scientifically sound stability claims that accelerate innovation and improve patient care.
Whether you are a manufacturer, researcher, or regulatory professional, this resource delivers actionable insights to streamline study design, reduce variability, and support compliance. By adopting these best practices, stakeholders can ensure specimen integrity, enhance diagnostic accuracy, and bring advanced technologies to patients faster.
Download the framework today and set the standard for specimen stability in clinical diagnostics.