CLSI EP List

Friendly Notes:

There are 3 EP standards provided free of charge in the official website: EP19, EP36 and CLSI QSRLDT (Quality System Regulations for Laboratory-Developed Tests). you may click the english title to reach the official shop to get them.

LineCodeTitle (CN)TitleLatest Version
1CLSI EP05定量测量程序的精确度评估，第3版Evaluation of Precision of Quantitative Measurement Procedures, 3rd Edition2014
2CLSI EP06定量测量程序线性评估，第2版Evaluation of Linearity of Quantitative Measurement Procedures, 2nd Edition2020
3CLSI EP07临床化学中的干扰测试，第3版Interference Testing in Clinical Chemistry, 3rd Edition2018
4CLSI EP09使用患者样本进行方法比较和偏差估计，第3版Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 3rd Edition2018
5CLSI EP10定量医学实验室测量程序初步评估，第4版Preliminary Evaluation of Quantitative Medical Laboratory Measurement Procedures, 4th Edition2024
6CLSI EP12定性二元输出试验性能评估（第三版）Evaluation of Qualitative, Binary Output Examination Performance, 3rd Edition2023
7CLSI EP14加工样品可比性评估，第4版Evaluation of Commutability of Processed Samples, 4th Edition2022
8CLSI EP15用户验证精度与偏差估计，第3版User Verification of Precision and Estimation of Bias, 3rd Edition2014
9CLSI EP17临床实验室测量程序检测能力评估，第2版Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures, 2nd Edition2012
10CLSI EP18实验室错误源识别与控制的风险管理技术，第2版Risk Management Techniques to Identify and Control Laboratory Error Sources, 2nd Edition2009
11CLSI EP19使用CLSI文件评估医学实验室测试方法的框架，第3版A Framework for Using CLSI Documents to Evaluate Medical Laboratory Test Methods, 3rd Edition2022
12CLSI EP21定量医学实验室测量程序的总分析误差评估，第二版Evaluation of Total Analytical Error for Quantitative Medical Laboratory Measurement Procedures, 2nd Edition2016
13CLSI EP23基于风险管理的实验室质量控制（第二版）Laboratory Quality Control Based on Risk Management, 2nd Edition2023
14CLSI EP24实验室检测诊断准确性的评估：接收者操作特征曲线，第2版Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves, 2nd Edition2011
15CLSI EP25体外医学实验室测试试剂的稳定性评估，第二版Evaluation of Stability of In Vitro Medical Laboratory Test Reagents, 2nd Edition2023
16CLSI EP26用户对试剂批次更换可接受性的评估，第二版User Evaluation of Acceptability of a Reagent Lot Change, 2nd Edition2022
17CLSI EP27构建和解释定量测量程序的误差网格，第二版Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures, 2nd Edition2022
18CLSI EP28临床实验室参考区间的定义、建立和验证，第3版Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory, 3rd Edition2010
19CLSI EP29实验医学中的测量不确定性表达，第1版Expression of Measurement Uncertainty in Laboratory Medicine, 1st Edition2012
20CLSI EP30实验医学可互换参考材料的表征与鉴定，第2版Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine, 2nd Edition2024
21CLSI EP31患者结果在一个医疗系统内的可比性验证，临时修订Verification of Comparability of Patient Results Within One Health Care System, Interim Revision2012
22CLSI EP32计量溯源及其实施，第1版Metrological Traceability and Its Implementation, 1st Edition2006
23CLSI EP33医学实验室中的三角检查使用，第二版Use of Delta Checks in the Medical Laboratory, 2nd Edition2023
24CLSI EP34建立和验证通过样本稀释和加标的扩展测量间隔，第一版Establishing and Verifying an Extended Measuring Interval Through Specimen Dilution and Spiking, 1st Edition2018
25CLSI EP35医学实验室测量程序样本类型的等效性或适用性评估，第一版Assessment of Equivalence or Suitability of Specimen Types for Medical Laboratory Measurement Procedures, 1st Edition2019
26CLSI EP36符号和方程式的协调，第一版Harmonization of Symbology and Equations, 1st Edition2015
27CLSI EP39评估体外医学实验室测试的替代样本选择的分层方法，第1版A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory Tests, 1st Edition2021
28CLSI EP43在紧急使用条件下实施实验室测试，第1版Implementing a Laboratory Test Under Emergency Use Conditions, 1st Edition2021
29CLSI EP47试剂残留对测试结果的影响评估，第一版Evaluation of Reagent Carryover Effects on Test Results, 1st Edition2024
30CLSI QSRLDT实验室开发测试的质量系统法规：实验室实用指南，第2版Quality System Regulations for Laboratory-Developed Tests: A Practical Guide for the Laboratory, 2nd Edition2024