CLSI EP21 A : 1ED 2003
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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ESTIMATION OF TOTAL ANALYTICAL ERROR FOR CLINICAL LABORATORY METHODS
12-07-2016
12-01-2013
Committee Membership
Foreword
1 Scope
2 Introduction
3 Definitions
4 General Principles
4.1 Cause and Effect Diagram of Medical Errors
4.2 The Importance of Total Analytical Error
4.3 Obtaining Total Analytical Error
4.4 Different Uses of Total Analytical Error
5 Protocols
5.1 Using NCCLS Document EP9 - Method Comparison and
Bias Estimation Using Patient Samples as the Basis
for Collecting the Data
5.2 Using Quality Control Samples
6 Data Analysis
6.1 Graphical Analysis
6.2 Total Analytical Error Estimation: Introduction
6.3 Total Analytical Error Estimation: outliers
6.4 Total Analytical Error Estimation: Nonparametric
Analysis
6.5 Parametric Analysis
6.6 A Review of Modeling Approaches
6.7 An Outline of a Simulation Method to Estimate
Total Analytical Error
6.8 Comparison of the Total Analytical Error Evaluation
Protocol With Other Evaluation Methods
7 Presentation of Results with Examples
7.1 Result Report Format
7.2 Result Report Interpretation
7.3 Example 1. LDL Cholesterol
7.4 Example 2. Sodium
References
Appendix A Factors (k) to Calculate Normal Distribution
Tolerance Intervals
Appendix B Number of Extreme Observations v to Be Removed
from the Ends of a Sample Size n to Obtain a
Two-Sided Distribution-Free Tolerance Interval
or to Obtain a One-Sided Distribution-Free
Tolerance Bound That Contains at Least 100 %
of the Sample Population with 100 (infinite)%
Confidence
Appendix C A Mathematical Representation of Total Analytical
Error
Summary of Consensus Comments and Committee Responses
Summary of Delegate Comments and Subcommittee Responses
The Quality System Approach
Related NCCLS Publications
Specifies protocols and procedures to estimate and report analytical error for clinical laboratory assays. These protocols and procedures are applicable to all quantitative analytical clinical laboratory methods.
DevelopmentNote |
Supersedes NCCLS EP21 P. (08/2003)
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DocumentType |
Miscellaneous Product
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PublisherName |
Clinical Laboratory Standards Institute
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Status |
Withdrawn
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SupersededBy | |
Supersedes |
CLSI EP19 : 2ED 2015 | A FRAMEWORK FOR USING CLSI DOCUMENTS TO EVALUATE CLINICAL LABORATORY MEASUREMENT PROCEDURES |
CLSI EP32 R : 1ED 2006 | METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION |
CLSI EP18 A2 : 2ED 2009 | RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES |
CLSI EP25 A : 1ED 2009 | EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS |
CLSI C52 A2 : 2ED 2007 | TOXICOLOGY AND DRUG TESTING IN THE CLINICAL LABORATORY |
CLSI EP22 P : 1ED 2010 | PRESENTATION OF A MANUFACTURER'S RISK MITIGATION INFORMATION FOR USERS OF IN VITRO DIAGNOSTIC DEVICES |
BS ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
CLSI EP27 A : 1ED 2012 | HOW TO CONSTRUCT AND INTERPRET AN ERROR GRID FOR QUANTITATIVE DIAGNOSTIC ASSAYS |
CLSI EP29 A : 1ED 2012 | EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE |
ISO 17593:2007 | Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
CLSI POCT9 A : 1ED 2010 | SELECTION CRITERIA FOR POINT-OF-CARE TESTING DEVICES |
CLSI I/LA28 A2 : 2ED 2011 | QUALITY ASSURANCE FOR DESIGN CONTROL AND IMPLEMENTATION OF IMMUNOHISTOCHEMISTRY ASSAYS |
CLSI EP18 P3 : 3ED 2009 | RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES |
CLSI H26 P2 : 2ED 2009 | VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS |
CLSI EP27 P : 1ED 2009 | HOW TO CONSTRUCT AND INTERPRET AN ERROR GRID FOR DIAGNOSTIC ASSAYS |
CLSI POCT9 P : 1ED 2009 | SELECTION CRITERIA FOR POINT-OF-CARE TESTING DEVICES |
CLSI MM6 A2 : 2ED 2010 | QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES |
CLSI NBS04 A : 1ED 2010 | NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY<br> |
CLSI C51 P : 1ED 2010 | EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE |
CLSI H26 A2 : 2ED 2010 | VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS |
CLSI NBS05 A : 1ED 2011 | NEWBORN SCREENING FOR CYSTIC FIBROSIS |
CLSI I/LA32 P : 1ED 2009 | NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY |
11/30208525 DC : 0 | BS EN ISO 15197 - IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
CLSI EP15 A3 : 3ED 2014 | USER VERIFICATION OF PRECISION AND ESTIMATION OF BIAS |
CLSI QMS01 A4 : 4ED 2011 | QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES |
CLSI EP18 P2 : 2ED 2007 | RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES |
CLSI GP34 A : 1ED 2010 | VALIDATION AND VERIFICATION OF TUBES FOR VENOUS AND CAPILLARY BLOOD SPECIMEN COLLECTION |
CLSI EP9 A3 : 3ED 2013 | MEASUREMENT PROCEDURE COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES |
CLSI GP31 A : 1ED 2009 | LABORATORY INSTRUMENT IMPLEMENTATION, VERIFICATION, AND MAINTENANCE |
PREN ISO 15197 : DRAFT 2011 | IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
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