Specimen Stability

Overview

The Specimen Stability project will develop a best practices framework to establish short-term specimen stability recommendations. Using the 2023 CLSI publication EP 25-Ed2 Evaluation of Stability of In Vitro Medical Laboratory Test Reagents as a model, the recommendations will take into account study designs, specimen types, storage conditions, storage durations, and appropriate data analyses. 

Specimen Stability Working Group

Active Specimen Stability Working Group members represent the following IVD stakeholders:

  • Abbott
  • Fujirebio
  • NowDx
  • Roche
  • Thermo Fisher
  • FDA

Explore ClinDx Resources

MDIC-FDA Workshop: Advancing EUA IVD Products Toward Full Marketing Status

Surrogate Sample Harmonized Education Modules

Framework for Developing Clinical Evidence for Regulatory and Coverage Assessments in In Vitro Diagnostics (IVDs)