CLSI Publishes Guideline For Evaluation Of Stability Of In Vitro Diagnostic Reagents

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Article Date: 05 Oct 2009 - 3:00 PDT

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Clinical and Laboratory Standards Institute (CLSI) recently published a new document, Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline (EP25-A). Stability of an in vitro diagnostic (IVD) reagent reflects its ability to maintain consistent performance characteristics over time. IVD reagents, in the context of this guideline, represent end-use consumable products sold for the purpose of performing clinical measurements on patient specimens or other samples. Examples of such products are IVD reagent kits and their associated calibrators, controls, sample diluents, and system generic reagents. Manufacturers are responsible for ensuring that stability claims are developed from experimental designs and data analyses that are appropriate for each product's particular requirements and applications. EP25-A includes background information and typical content to consider when creating a stability testing plan for a particular product, logistics of performing the studies, recommended data analyses, and documentation of stability claims.

James F. Pierson-Perry, core team leader and in-house consultant for Siemens Healthcare Diagnostics, and chairholder of the subcommittee that developed the guideline, says, "EP25-A provides background information, experimental designs, and guidance for establishment and verification of shelf-life and in-use stability claims of IVD reagents. The document's primary intended audiences are IVD manufacturers and regulatory agencies that must address the practical implementation of product stability testing requirements. This guideline is aligned with the European Standard EN 13640:2002-Stability Testing of In Vitro Diagnostic Reagents. Clinical laboratorians may find EP25-A useful in interpreting commercial product stability claims, as well as in establishing stability attributes of 'laboratory-developed' test methods."

Key topics addressed in the guideline include

- Development of the experimental design and acceptance criteria for the stability plan
- Types of stability studies and design options
- Stability study protocol, data analyses, and documentation of stability studies
- Real-time stability verification and accelerated stability testing
- Examples provided in the appendixes

Pierson-Perry concludes, "Current stability-related literature and standards are largely dominated by the needs of pharmaceutical products. EP25-A addresses the gap for IVD reagent products by providing information and a collection of best practices to guide manufacturers with establishment of robust product stability claims. It also should facilitate regulatory submissions by providing a means to anchor product stability claims to a global consensus document."

CLSI intends to submit EP25-A to the US Food and Drug Administration (FDA) for consideration as an FDA-recognized consensus guideline.

Source
Clinical and Laboratory Standards Institute