CLSI EP25 A : 1ED 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS
Hardcopy , PDF
05-13-2023
English
09-23-2009
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Abstract
Committee Membership
Foreword
1 Scope
2 Standard Precautions
3 Terminology
4 Overview of the Stability Testing Process
5 Real-time Stability Study Protocol
6 Real-time Stability Monitoring (Verification)
7 Accelerated Stability Testing
References
Appendix A - Measurand Drift Analysis Example
Appendix B - Example of Use of Arrhenius Equation With
Accelerated Stability Testing Data to Predict
Shelf Life of an In Vitro Diagnostic Control
Product
Appendix C - Determining the Number of Time Points and
Repeats of Stability Studies Based on Linear
Regression Analysis
Summary of Comments and Subcommittee Responses
Laboratory Failure Sources and CLSI Evaluation Protocols
Documents
The Quality Management System Approach
Related CLSI Reference Materials
Gives guidance for establishing shelf-life and in-use stability claims for in vitro diagnostic reagents such as reagent kits, calibrators, and control products.
| DevelopmentNote |
Supersedes NCCLS EP25 P. (01/2010)
|
| DocumentType |
Standard
|
| ISBN |
1-56238-706-5
|
| Pages |
52
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| CLSI EP19 : 2ED 2015 | A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES |
| CLSI MM7 A2 : 2ED 2013 | FLUORESCENCE IN SITU HYBRIDIZATION METHODS FOR CLINICAL LABORATORIES |
| ISO 23640:2011 | In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents |
| CLSI I/LA20 : 3ED 2016 | ANALYTICAL PERFORMANCE CHARACTERISTICS, QUALITY ASSURANCE, AND CLINICAL UTILITY OF IMMUNOLOGICAL ASSAYS FOR HUMAN IMMUNOGLOBULIN E ANTIBODIES OF DEFINED ALLERGEN SPECIFICITIES |
| CLSI EP36 : 1EDE 2015 | HARMONIZATION OF SYMBOLOGY AND EQUATIONS |
| UNE-EN ISO 23640:2015 | In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011) |
| BS EN ISO 23640:2015 | In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents |
| EN ISO 23640:2015 | In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011) |
| CLSI QMS01 A4 : 4ED 2011 | QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES |
| CLSI EP5 A3 : 3ED 2014 | Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition<br> |
| I.S. EN ISO 23640:2015 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS (ISO 23640:2011) |
| DIN EN ISO 23640:2015-12 | IN VITRO DIAGNOSTIC MEDICAL DEVICES - EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS (ISO 23640:2011) |
| CLSI EP14 A2 : 2ED 2005 | EVALUATION OF MATRIX EFFECTS |
| CLSI EP21 A : 1ED 2003 | ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS |
| CLSI EP5 A2 : 2ED 2004 | EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS |
| CLSI EP12 A2 : 2ED 2008 | USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE |
| CLSI GP10 A : 1ED 95(R2001) | ASSESSMENT OF THE CLINICAL ACCURACY OF LABORATORY TESTS USING RECEIVER OPERATING CHARACTERISTIC (ROC) PLOTS |
| CLSI EP6 A : 1ED 2003 | EVALUATION OF THE LINEARITY OF QUANTITATIVE MEASUREMENT PROCEDURES - A STATISTICAL APPROACH |
| CLSI M29 A3 : 3ED 2005 | ACQUIRED INFECTIONS; APPROVED GUIDELINE |
| CLSI EP15 A2 : 2ED 2006 | USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS |
| CLSI EP19 R : 1ED 2002 | A FRAMEWORK FOR NCCLS EVALUATION PROTOCOLS |
| CLSI EP17 A : 1ED 2004 | PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION |
| CLSI EP7 A2 : 2ED 2005 | INTERFERENCE TESTING IN CLINICAL CHEMISTRY |
| CLSI EP18 A : 1ED 2002 | QUALITY MANAGEMENT FOR UNIT-USE TESTING |
| CLSI EP9 A2 : 2ED 2002 | METHOD COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES |
| CLSI EP10 A3 : 2006 + A1 2014 | PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES |
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