CLSI EP10 A3 : 2006 + A1 2014
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
PRELIMINARY EVALUATION OF QUANTITATIVE CLINICAL LABORATORY MEASUREMENT PROCEDURES
Hardcopy , PDF
28-11-2019
English
24-08-2018
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Abstract
Committee Membership
Summary of Changes in EP10 Amendment
Foreword
1 Scope
2 Introduction
3 Standard Precautions
4 Terminology
5 Materials
6 Calibration and Sequence of Samples in a Run
7 Number of Days and Runs
8 Preliminary Procedures
9 Collection and Recording of Data
10 Initial Data Plotting and Inspection
11 Analysis of the Data for Imprecision
12 Preliminary Assessment of Bias
13 Full Data Analysis Procedures
14 An Alternative Procedure
15 Use of EP10 by Manufacturers
16 How to Perform Multiple Regression for EP10
References
Symbols Used in Appendixes
Appendix A - Preliminary Performance Acceptability Check
Appendix B - Example Use of Data Sheets
Appendix C - Statistical Explanation
The Quality System Approach
Evaluation Protocols Documents, Descriptions, and Key Words
Before starting a complete evaluation of a new measurement procedure, kit, or instrument for in vitro diagnostic use, it is often necessary to make a preliminary decision about its acceptability.
| DevelopmentNote |
Supersedes NCCLS EP10 A2. (11/2006) 2006 Edition Re-Issued in May 2014 & incorporates AMD 1 2014. (05/2014)
|
| DocumentType |
Miscellaneous Product
|
| ISBN |
1-56238-622-0
|
| Pages |
70
|
| 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Superseded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 EP18 P2 : 2ED 2007 | RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES |
| CLSI H48 : 2ED 2016 | DETERMINATION OF COAGULATION FACTOR ACTIVITIES USING THE ONE-STAGE CLOTTING ASSAY |
| 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 EP29 A : 1ED 2012 | EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE |
| CLSI POCT12 A3 : 3ED 2013 | Point-of-Care Blood Glucose Testing in Acute and Chronic Care Facilities; Approved Guideline—Third Edition<br> |
| CLSI POCT7 A :2010(R2018) | Validation and Verification of Tubes for Venous and Capillary Blood Specimen Collection |
| 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 H57 A : 1ED 2008 | PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS |
| CLSI C52 A2 : 2ED 2007 | TOXICOLOGY AND DRUG TESTING IN THE CLINICAL LABORATORY |
| CLSI GP34 P : 1ED 2009 | VALIDATION AND VERIFICATION OF TUBES FOR VENOUS AND CAPILLARY BLOOD SPECIMEN COLLECTION |
| CLSI I/LA32 P : 1ED 2009 | NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY |
| CLSI I/LA34 P : 1ED 2010 | DESIGN AND VALIDATION OF IMMUNOASSAYS FOR ASSESSMENT OF HUMAN ALLERGENICITY OF NEW BIOTHERAPEUTIC DRUGS |
| CLSI MM6 A2 : 2ED 2010 | QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES |
| CLSI C34 A3 : 3ED 2009 | SWEAT TESTING: SAMPLE COLLECTION AND QUANTITATIVE CHLORIDE ANALYSIS |
| CLSI H20 A2 : 2ED 2007 | Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods, 2nd Edition<br> |
| CLSI MM19 P : 1ED 2011 | ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS |
| CLSI NBS05 A : 1ED 2011 | NEWBORN SCREENING FOR CYSTIC FIBROSIS |
| CLSI C57 : 1ED 2015 | MASS SPECTROMETRY FOR ANDROGEN AND ESTROGEN MEASUREMENTS IN SERUM |
| CLSI H57 P : 1ED 2007 | PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS |
| CLSI NBS04 A : 1ED 2010 | NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY<br> |
| CLSI MM19 A : 1ED 2011 | ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS |
| 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 GP34 A : 1ED 2010 | VALIDATION AND VERIFICATION OF TUBES FOR VENOUS AND CAPILLARY BLOOD SPECIMEN COLLECTION |
| CLSI GP16-A3 : 2009 | Urinalysis; Approved Guideline—Third Edition |
| CLSI EP5 A3 : 3ED 2014 | Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline—Third Edition<br> |
| CLSI I/LA20 A2 : 2ED 2009 | ANALYTICAL PERFORMANCE CHARACTERISTICS AND CLINICAL UTILITY OF IMMUNOLOGICAL ASSAYS FOR HUMAN IMMUNOGLOBULIN E (IGE) ANTIBODIES AND DEFINED ALLERGEN SPECIFICITIES |
| CLSI EP22 P : 1ED 2010 | PRESENTATION OF A MANUFACTURER'S RISK MITIGATION INFORMATION FOR USERS OF IN VITRO DIAGNOSTIC DEVICES |
| CLSI C50 A : 1ED 2007 | MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE |
| CLSI C49:2018(R2023) | Analysis of Body Fluids in Clinical Chemistry |
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