ep10-a3 定量臨床檢驗(yàn)方法的初步評(píng)價(jià)

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