CLSI EP25-A PDF

CLSI EP25-A – Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline, EP25A

Clinical and Laboratory Standards Institute document EP25-A–Evaluation of Stability of In Vitro Diagnostic Reagents;Approved Guideline provides guidance and regression-based procedures for establishing stability-related claims of in vitrodiagnostic (IVD) reagents such as reagent kits, calibrators, control products, and sample diluents. This guideline was writtenprimarily for manufacturers and regulatory agencies, but will also be of interest to clinical laboratories. It provides information onthe design, implementation, data analysis, and documentation needs for studies to establish and verify shelf life and in-use life ofIVD reagents. Additional topics address assessment of product transport conditions on stability and accelerated stability testing.