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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 Guideline—Third EditionThis guideline provides experimental desig
2、n and data analysis for preliminary evaluation of the performance of a measurement procedure or device. A guideline for global application developed through the Clinical and Laboratory Standards Institute consensus pro
3、cess. Volume 26 EP10-A3vContents Abstract....................................................................................................................................................i Committee Membership........
4、................................................................................................................ iii Foreword...............................................................................................
5、............................................... vii Laboratory Error Sources and CLSI Evaluation Protocols Documents.............................................. viii 1 Scope............................................
6、..............................................................................................1 2 Introduction.............................................................................................................
7、...................1 3 Standard Precautions..................................................................................................................1 4 Terminology..............................................
8、.................................................................................2 4.1 A Note on Terminology................................................................................................2 4.2 Definit
9、ions ....................................................................................................................2 5 Materials ....................................................................................
10、................................................5 5.1 Reference Procedures ...................................................................................................5 6 Calibration and Sequence of Samples in a
11、 Run .........................................................................6 7 Number of Days and Runs.........................................................................................................6 8 Prel
12、iminary Procedures..............................................................................................................6 9 Collection and Recording of Data.......................................................
13、.......................................6 10 Initial Data Plotting and Inspection ...........................................................................................6 10.1 Difference Plot of Data vs. Concentrati
14、on....................................................................6 10.2 Visual Inspection for Outliers.......................................................................................9 10.3 Visual Inspecti
15、on for Linearity.....................................................................................9 11 Analysis of the Data for Imprecision.............................................................................
16、............9 11.1 Interpretation.................................................................................................................9 12 Preliminary Assessment of Bias ....................................
17、..........................................................10 12.1 Assigned Values .........................................................................................................10 12.2 Calculation of Bias...
18、...................................................................................................10 12.3 Interpretation.................................................................................................
19、..............10 13 Full Data Analysis Procedures.................................................................................................10 13.1 A Comment on the Model .........................................
20、.................................................11 13.2 Summarizing the Five Runs........................................................................................11 14 An Alternative Procedure ................
21、........................................................................................11 15 Use of EP10 by Manufacturers................................................................................................1
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