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1、EP10-A3 Vol. 26 No. 34 Replaces EP10-A2 Vol. 22 No. 29 Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved GuidelineThird Edition This guideline provides experimental design and data analysis for preliminary evaluation of the performance of a measurement proce
2、dure or device. A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus process. EP10-A3 ISBN 1-56238-622-0 Volume 26 Number 34 ISSN 0273-3099 Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved GuidelineT
3、hird Edition Jan S. Krouwer, PhD George S. Cembrowski, MD, PhD Daniel W. Tholen, MS Abstract Clinical and Laboratory Standards Institute document EP10-A3Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved GuidelineThird Edition is intended to facilitate a limi
4、ted, preliminary evaluation of the performance of a measurement procedure or device. Using the experimental design and data analysis procedure described, determination of whether a device has problems that require further evaluation or referral to the manufacturer can be done with a minimum expendit
5、ure of time and material. Included in Appendixes A and B are sample data sheets that should facilitate the analysis of the data. Appendix C contains a more sophisticated, powerful, statistical method for determining the possible causes of imprecision. Clinical and Laboratory Standards Institute (CLS
6、I). Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved GuidelineThird Edition. CLSI document EP10-A3 (ISBN 1-56238-622-0). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2006. (Formerly NCCLS
7、) The Clinical and Laboratory Standards Institute consensus process, which is the mechanism for moving a document through two or more levels of review by the healthcare community, is an ongoing process. Users should expect revised editions of any given document. Because rapid changes in technology m
8、ay affect the procedures, methods, and protocols in a standard or guideline, users should replace outdated editions with the current editions of CLSI/NCCLS documents. Current editions are listed in the CLSI catalog, which is distributed to member organizations, and to nonmembers on request. If your
9、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: customerserviceclsi.org; Website: www.clsi.org Volume 26 EP10-A3 v Contents Abstracti Committee Membership iii Foreword vii Laboratory E
10、rror Sources and CLSI Evaluation Protocols Documents viii 1 Scope1 2 Introduction1 3 Standard Precautions1 4 Terminology.2 4.1 A Note on Terminology2 4.2 Definitions 2 5 Materials 5 5.1 Reference Procedures .5 6 Calibration and Sequence of Samples in a Run.6 7 Number of Days and Runs.6 8 Preliminary
11、 Procedures6 9 Collection and Recording of Data6 10 Initial Data Plotting and Inspection .6 10.1 Difference Plot of Data vs. Concentration6 10.2 Visual Inspection for Outliers.9 10.3 Visual Inspection for Linearity.9 11 Analysis of the Data for Imprecision.9 11.1 Interpretation.9 12 Preliminary Asse
12、ssment of Bias 10 12.1 Assigned Values .10 12.2 Calculation of Bias10 12.3 Interpretation.10 13 Full Data Analysis Procedures.10 13.1 A Comment on the Model 11 13.2 Summarizing the Five Runs11 14 An Alternative Procedure 11 15 Use of EP10 by Manufacturers11 16 How to Perform Multiple Regression for
13、EP10 in Excel.11 Number 34 EP10-A3 vi Contents (Continued) References.14 Symbols Used in Appendixes.15 Appendix A. Preliminary Performance Acceptability Check.16 Appendix B. Example Use of Data Sheets .22 Appendix C. Statistical Explanation43 Summary of Consensus Comments and Committee Responses.46
14、Summary of Delegate Comments and Committee Responses48 The Quality System Approach50 Evaluation Protocols Documents, Descriptions, and Key Words.51 Volume 26 EP10-A3 vii Foreword Before using a new measurement procedure or instrument for in vitro diagnostic use, the laboratory must make a preliminar
15、y decision about its acceptability. This initial performance check is neither a rigorous characterization of long-term performance nor an evaluation of the many factors that can affect results produced by the device. Rather, this experiment is a quick check to rule out major problems and a starting
16、point for accumulating data and experience that will enable the user to make a final decision. The primary purpose of this document is to help detect performance problems that would warrant immediate correction, referral to the manufacturer, or expanded investigation before a new device is placed into service. This document may also now be used by manufacturers to either establish the magnitude of factors that can affect performance or verify that such
