CLSI EP25-A Test Standard for Evaluation of Stability of In Vitro Diagnostic Reagents

This standard provides information on the establishment and verification of shelf-life and in-use stability claims for quantitative and qualitative in vitro diagnostic reagents. It includes background information and typical content to consider when creating a stability test plan for a particular product, the logistics of performing studies, proposed data analyzes and documentation of stability claims. Additional topics include evaluating product transport conditions for stability claims, stability monitoring, and uses of accelerated stability testing.

The target users of this standard are primarily manufacturers of IVD reagents and regulatory bodies. Clinical laboratory practitioners may find this information useful in interpreting commercial product stability claims, as well as determining the stability characteristics of "lab developed test" methods.

This standard does not address instrument systems, laboratory equipment, software, or patient samples. Stability testing of raw materials or components of reagent kits or consumables is not explicitly addressed. However, the principles described in this document may be tailored for this purpose by manufacturers.

EUROLAB assists manufacturers with CLSI EP25-A test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.