EP25-A
Vol. 29 No. 20
Replaces EP25-P
Vol. 28 No. 32 Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline This document provides guidance for establishing shelf-life and in-u stability claims for in vitro diagnostic reagents such as reagent kits, calibrators, and control products.
A guideline for global application developed through the Clinical and Laboratory Standards Institute connsus process.
EP25-A
ISBN 1-56238-706-5 Volume 29 Number 20 ISSN 0273-3099 Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline
James F. Pierson-Perry
Sousan S. Altaie, PhD
Susan J. Danielson, PhD
Birgitte Lund Jorgenn, PhD
Bettina Poetsch, PhD
Rosanne M. Savol, RAC丰收节作文
Jeffrey E. Vaks, PhD
Jeffrey Budd, PhD
Karl De Vore
Robert Magari, PhD
Abstract
Clinical and Laboratory Standards Institute document EP25-A—Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline provides guidance and regression-bad procedures for establishing stability-related claims of in vitro diagnostic (IVD) reagents such as reagent kits, calibrat
ors, control products, and sample diluents. This guideline was written primarily for manufacturers and regulatory agencies, but will also be of interest to clinical laboratories. It provides information on the design, implementation, data analysis, and documentation needs for studies to establish and verify shelf life and in-u life of IVD reagents. Additional topics address asssment of product transport conditions on stability and accelerated stability testing. Clinical and Laboratory Standards Institute (CLSI). Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline. CLSI document EP25-A (ISBN 1-56238-706-5). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2009.
The Clinical and Laboratory Standards Institute connsus process, which is the mechanism for moving a document through two or more levels of review by the health care community, is an ongoing process. Urs should expect revid editions of any given document. Becau rapid changes in technology may affect the procedures, methods, and protocols in a standard or guideline, urs should replace outdated editions with the current editions of CLSI/NCCLS documents. Current editions are listed in the CLSI catalog and posted on our website at www.clsi. If your organization is not a member and would like to become one, and to request a copy of the catalog, contact us at: Telephone: 610.688.0100; Fax: 610.688.0700; E-Mail: customerrvice@clsi; Website: www.clsi
Abstract (i)
Committee Membership (iii)
Foreword (vii)
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1 Scope (1)
2 Standard Precautions (1)
3 Terminology (1)
3.1 A Note on Terminology (1)
3.2 Definitions (2)
3.3 Abbreviations and Acronyms (4)
4 Overview of the Stability Testing Process (4)
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4.1 Operational Definition of Stability (5)
4.2 Types of Stability Studies (8)
4.3 Stability Study Design Options (9)
软件研发工程师4.4 The Stability Testing Plan (9)
4.5 Extension to Qualitative Methods (11)
4.6 Documentation of Stability Studies (11)
5 Real-time Stability Study Protocol (11)
政协工作总结5.1 Planning (11)
5.2 Experimental (12)
5.3 Data Analysis (13)
6 Real-time Stability Monitoring (Verification) (15)
7 Accelerated Stability Testing (15)
7.1 Applications of Accelerated Stability Testing (15)
7.2 Considerations for Planning Temperature-Bad Accelerated Stability Studies (16)
7.3 Analysis of Accelerated Stability Testing Data for Shelf-Life Claims (17)
References (20)
Appendix A. Measurand Drift Analysis Example (22)
Appendix B. Example of U of Arrhenius Equation With Accelerated Stability Testing Data to Predict Shelf Life of an In Vitro Diagnostic Control Product (24)
Appendix C. Determining the Number of Time Points and Repeats for Stability Studies Bad on Linear Regression Analysis (26)
Summary of Comments and Subcommittee Respons (29)
Laboratory Failure Sources and CLSI Evaluation Protocols Documents (36)
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The Quality Management System Approach (38)
Related CLSI Reference Materials (39)
v
Stability of an in vitro diagnostic (IVD) reagent reflects its ability to maintain consistent performance characteristics over time. Unlike precision, bias, and other common performance attributes, product stability is rarely assd directly by customer testing. As such, there is incread burden on manufacturers to ensure that stability claims are developed from experimental designs and data analys that are appropriate for each product’s particular requirements and applications.
IVD reagents, in the context of this guideline, reprent end-u consumable products sold for the purpo 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.
Content of this guideline is aligned with European Standard EN 13640:2002—Stability Testing of In Vitro Diagnostics Reagents,1 referenced herein as EN 13640. Two other important internationally recognized guidance documents relative to stability study design and analys are International Conference on Harmonization (ICH) Q1A (R2)2 and ICH Q1E.3 Although the were developed for drugs and drug substances, much of their content is directly relevant to IVD reagents.4
Key Words
Accelerated stability, allowable drift, calibration interval, expiration dating, in-u life, shelf life, stability monitoring, stability plan, transport simulation
vii
Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline 1Scope
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This guidance document provides information on the establishment and verification of shelf-life and in-u stability claims for quantitative and qualitative in vitro diagnostic (IVD) reagents. It 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 analys, and documentati婚礼感谢致辞
on of stability claims. Additional topics include asssment of product transport conditions on stability claims, stability monitoring (verification), and us of accelerated stability testing.
The intended urs of this guideline are primarily manufacturers of IVD reagents and regulatory agencies. Clinical laboratorians may find this information uful in interpreting commercial product stability claims, as well as for establishing stability attributes of “laboratory-developed test” methods.
This guideline 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 addresd explicitly. The principles described in this document could, however, be adapted by manufacturers toward that purpo.
2Standard Precautions
Becau it is often impossible to know what isolates or specimens might be infectious, all patient and laboratory specimens are treated as infectious and handled according to “standard precautions.” Standard precautions are guidelines that combine the major features of “universal precautions and body substance isolation” practices. Standard precautions cover the transmission of all infectious agents and thus are more comprehensive than universal precautions, which are intended to apply on
ly to transmission of blood-borne pathogens. Standard and universal precaution guidelines are available from the US Centers for Dia Control and Prevention.5 For specific precautions for preventing the laboratory transmission of all infectious agents from laboratory instruments and materials and for recommendations for the management of exposure to all infectious dia, refer to CLSI document M29.6
3Terminology
3.1 A Note on Terminology
CLSI, as a global leader in standardization, is firmly committed to achieving global harmonization wherever possible. Harmonization is a process of recognizing, understanding, and explaining differences while taking steps to achieve worldwide uniformity. CLSI recognizes that medical conventions in the global metrological community have evolved differently in the United States, Europe, and elwhere; that the differences are reflected in CLSI, International Organization of Standardization (ISO), and European Committee for Standardization (CEN) documents; and that legally required u of terms, regional usage, and different connsus timelines are all important considerations in the harmonization process. In light of this, CLSI’s connsus process for developm
ent and revision of standards focus on harmonization of terms to facilitate the global application of standards.
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