(ASCP) Jan Krouwer, Ph.D. Fred Lasky, Ph.D. Abstract NCCLS document EP6-A— Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline is intended to provide both manufacturers and users of quantitative analytical methods with an economical and ...
NCCLS CLSI标准文件汇总-EP6-A.pdf,EP6-A Vol. 23 No. 16 Replaces EP6-P2 Vol. 21 No. 20 Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline This document provides guidance for characterizing the lin
Guideline-Second Edition. 2. EP5-A: Evaluation of precision performance of clinical chemistry devices; Approved Guideline. 3. EP6-A: Evaluation of the linearity of quantitative measurement procedures; A Statistical Approach; Approved Guideline. 4. EP7-A: Interference testing in clinical chemistry; ...
1. C28-A2: How to define and determine reference intervals in the clinical laboratory; ApprovedGuideline-Second Edition. 2. EP5-A: Evaluation of precision performance of clinical chemistry devices; Approved Guideline. 3. EP6-A: Evaluation of the linearity of quantitative measurement procedures; A...
EP12-A2,User Protocol for Evaluationof Qualitative Test Performance; Approved Guideline—Second Edition. 检测限(EP17-A) 概述 检测限评估资料是评价拟上市产品有效性的重要依据,也是产品注册所需的重要申报资料之一。 空白限值:Limit of Blank(LoB) ...
EP6-A: Evaluation of the linearity of quantitative measurement procedures; A Statistical Approach; Approved Guideline. EP7-A: Interference testing in clinical chemistry; Approved Guideline. EP9-A2: Method comparison and bias estimation using patient samples; Approved Guideline-Second Edition. ...
23、utions, technometrics 2:4, 1960 graybill, franklin a. an introduction to linear statistical models, volume i, mcgraw-hill book company, 1961, p191.evaluation of precision performance of clinical chemistry devices, approved guideline, 1984ep5 批内批内 批间批间 日内日内 日间日间 总精密度...
临床检验方法的评价CLSI-EP文件 临床检验方法的评价 郭健卫生部临检中心 方法选择方法评价常规分析前准备 样品 常规分析 方法发展预防措施 统计质控 报告结果 分析方法分级 决定性方法(definitivemethod):经详尽研究尚未发现不准确度或不确定性原因的方法。参考方法(referencemethod):经详尽研究证实其不准确度与不精密...
An introduction to linear statistical models, volume I, McGraw-Hill Book Company, 1961, p191,54,特选课堂,临床化学设备的精密度评价,Evaluation of Precision Performance of Clinical Chemistry Devices, Approved Guideline, 1984,EP5,55,特选课堂,精密度的内容,批内 批间 日内 日间 总精密度,56,特选...
NCCLS C21-A 1992.01.01 Performance Characteristics for Devices Measuring PO2 and PCO2 in Blood Samples性能特点的设备测量氧及二氧化碳分压的血液样本 NCCLS C24-A 1991.01.01 Internal Quality Control Testing: Principles and Definitions, Approved Guideline内部质量控制测试:原理和定义,批准指南 NCCLS C25-T 19...