CLSI EP5 A3 : 3ED 2014
Current
The latest, up-to-date edition.
Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition
Hardcopy , PDF
English
01-10-2014
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Abstract
Committee Membership
Foreword
Chapter 1 - Introduction
Chapter 2 - Selecting and Optimizing an Appropriate
Precision Evaluation Protocol
Chapter 3 - Single-Site Precision Evaluation Study
Chapter 4 - Multisite Precision Evaluation Study
Chapter 5 - Conclusion
Chapter 6 - Supplemental Information
References
Appendix A - Worked Example - Single-Site Study
Appendix B - Worked Example - Multisite Study
Appendix C - Advanced Models
The Quality Management System Approach
Related CLSI Reference Materials
This document provides guidance for evaluating the precision performance of quantitative measurement procedures.
| DevelopmentNote |
Supersedes CLSI EP5 A2. (09/2014)
|
| DocumentType |
Guide
|
| ISBN |
1-56238-968-8
|
| Pages |
120
|
| PublisherName |
Clinical Laboratory Standards Institute
|
| Status |
Current
|
| Supersedes |
| CLSI EP19 : 2ED 2015 | A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES |
| CLSI POCT17 : 1ED 2016 | USE OF GLUCOSE METERS FOR CRITICALLY ILL PATIENTS |
| CLSI H48 : 2ED 2016 | DETERMINATION OF COAGULATION FACTOR ACTIVITIES USING THE ONE-STAGE CLOTTING ASSAY |
| ISO 16142-2:2017 | Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| CLSI MM3 A3 : 3ED 2015 | MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES |
| CLSI EP21 : 2ED 2016 | EVALUATION OF TOTAL ANALYTICAL ERROR FOR QUANTITATIVE MEDICAL LABORATORY MEASUREMENT PROCEDURES |
| ANSI/AAMI/ISO 16142-2:2017 | MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS |
| CLSI C24 : 4ED 2016 | STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS |
| 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 |
| BS ISO 16142-2:2017 | Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards |
| CLSI MM23 : 1ED 2015 | MOLECULAR DIAGNOSTIC METHODS FOR SOLID TUMORS (NONHEMATOLOGICAL NEOPLASMS) |
| CLSI C57 : 1ED 2015 | MASS SPECTROMETRY FOR ANDROGEN AND ESTROGEN MEASUREMENTS IN SERUM |
| CLSI EP36 : 1EDE 2015 | HARMONIZATION OF SYMBOLOGY AND EQUATIONS |
| CLSI EP15 A3 : 3ED 2014 | USER VERIFICATION OF PRECISION AND ESTIMATION OF BIAS |
| CLSI EP17 A2 : 2ED 2012 | EVALUATION OF DETECTION CAPABILITY FOR CLINICAL LABORATORY MEASUREMENT PROCEDURES |
| CLSI EP12 A2 : 2ED 2008 | USER PROTOCOL FOR EVALUATION OF QUALITATIVE TEST PERFORMANCE |
| CLSI EP29 A : 1ED 2012 | EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE |
| CLSI EP15 A3 : 3ED 2014 | USER VERIFICATION OF PRECISION AND ESTIMATION OF BIAS |
| CLSI EP25 A : 1ED 2009 | EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS |
| CLSI C24 A3 : 3ED 2006 | STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS |
| CLSI EP10 A3 : 2006 + A1 2014 | PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES |
| CLSI C56 A : 1ED 2012 | HEMOLYSIS, ICTERUS, AND LIPEMIA/TURBIDITY INDICES AS INDICATORS OF INTERFERENCE IN CLINICAL LABORATORY ANALYSIS |
| CLSI M29 A4 : 4ED 2014 | Protection of Laboratory Workers From Occupationally Acquired Infections<br> |
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