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Evaluation of Stability of In Vitro Medical Laboratory Test Reagents, 2nd Edition

This guideline provides recommendations for establishing and verifying shelf-life and in-use stability claims for in vitro diagnostic medical laboratory test reagents such as reagent kits, calibrators, and control products.

This edition of the document was corrected in February 2024 and April 2024. Read the correction notices by accessing the link above, and learn more about our correction process here.

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Chairholder: Karl De Vore, BA, SSBB

Date of Publication: April 26, 2023

Order Code PDF: CLSI EP25Ed2E
ISBN Number: 978-1-68440-179-6

Order Code Print: CLSI EP25Ed2
ISBN Number: 978-1-68440-178-9

Edition: Second

Pages: 124

CLSI EP25 Additional Details

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The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

CLSI EP25 Abstract

Clinical and Laboratory Standards Institute guideline EP25—Evaluation of Stability of In Vitro Medical Laboratory Test Reagents provides recommendations and regression‑based procedures for establishing and subsequently confirming stability‑related claims of in vitro medical laboratory reagents such as reagent kits, calibrators, control products, and sample diluents. This guideline was written primarily for manufacturers and regulatory agencies but will also be of interest to medical laboratories and developers of laboratory‑developed test methods. It provides information on the design, implementation, data analysis, and documentation needs for studies to establish and confirm shelf life and in‑use life of in vitro diagnostic products. Additional topics cover the assessment of product transport conditions on stability, use of mean kinetic temperature to reflect product exposure to temperature changes during distribution and storage, and accelerated stability testing.