18张传宝,精密度和正确度的性能验证
时间:2025-04-04
时间:2025-04-04
精密度和正确度性能验证卫生部临床检验中心 张传宝PDF 文件使用 "pdfFactory Pro" 试用版本创建 http://
主要内容1 2 3 4 5前言 概念 注意事项 精密度验证 正确度验证PDF 文件使用 "pdfFactory Pro" 试用版本创建 http://
前言 p Why p When p Who p Where p WhatPDF 文件使用 "pdfFactory Pro" 试用版本创建 http://
前言-WHYp 《医疗机构临床实验室管理办法》 (2006) Ø 第三章 医疗机构临床实验室质量管理 Ø 第二十四条 医疗机构临床实验室应当保证检测系统的完整性和有效性,对需要 校准的检验仪器、检验项目和对临床检验结果有影响的辅助设备定期进行校准。 p 《医疗机构临床实验室管理办法》三级甲等医院考核检查表 Ø 3章24条: Ø 20.1 是否对检测系统(仪器设备、试剂、校准品)进行了有效性的评价?包括对准 Ø Ø Ø Ø 确度、精密度、分析测量范围、参考范围、分析干扰等的评估。 20.2 每个项目是否具备详尽的校准程序?是否记录了校准结果? 20.3 是否能提供校准品的溯源证明? 20.4 是否建立了分析测量范围的验证程序? 20.5 是否验证了分析测量范围?PDF 文件使用 "pdfFactory Pro" 试用版本创建 http://
前言-WHY医学实验室认可的相关文件 Ø CNAS—CL02 《医学实验室质量和能力认可准则》(ISO 15189:2007) Ø CNAS-GL21《医学实验室质量和能力认可准则在临床生物化学检验领域 的指南》5PDF 文件使用 "pdfFactory Pro" 试用版本创建 http://
前言-WHYCNAS CL-002 (ISO 15189)§ 5.5 检验程序使用经确认的程序,性能适合其预期用途(5.5.2) 用于检验之前予以评估,证实可给出满意结果(5.5.2) § 5.6 检验程序的质量保证 运行内部质量控制体系(5.6.1) 适用且可能时,评定检验结果的不确定度(5.6.2) 实施校准和正确度验证计划,保证结果溯源性。如果无法实现或不适用,采用其 他方式保证结果的可信度(5.6.3) 参加如外部质量评价计划(5.6.4)PDF 文件使用 "pdfFactory Pro" 试用版本创建 http://
前言-WHYCNAS-GL21PDF 文件使用 "pdfFactory Pro" 试用版本创建 http://
前言-WHYThe U.S. CLIA RulesSec. 493.1253 Standard: Establishment and verification of performance specifications (a) Applicability. Laboratories are not required to verify or establish performance specifications for any test system used by the laboratory before April 24, 2003. (b) -(1) Verification of performance specifications. Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for FDA批准方法 the following performance characteristics: (A) Accuracy (B) Precision (C) Reportable range of test results for the test system (ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. (2) Establishment of performance specifications. Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures, Gram stain, or potassium hydroxide preparations), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable: a)修改FDA批准方法 (i) Accuracy. b)未经FDA批准方法 (ii) Precision. c)经批准,但厂家未提供性能指标 (iii) Analytical sensitivity. (iv) Analytical specificity to include interfering substances. (v) Reportable range of test results for the test system. (vi) Reference intervals (normal values). (vii) Any other performance characteristic required for test performance.PDF 文件使用 "pdfFactory Pro" 试用版本创建 http://
前言-WHY欧盟关于体外诊断器具指令 Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (for implementation in the member states by December 2003) ANNEX I ESSENTIAL REQUIREMENTS A. GENERAL REQUIREMENTS ... ... 3 ... ... (The devices) must achieve the performances, in particular, where appropriate, in terms of analytical sensitivity, diagnostic sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, reproducibility, including control of known relevant interference, and limits of detection, stated by the manufacturer. The traceability of values assigned to calibrators and/or control materials must be assured through available reference measurement procedures and/or available reference materials of a higher order“器具必须达到声称的分析和诊断灵敏度、特异性、准确性、重复性、重现性等性能,包括 已知干扰的控制、检测限等。” “校准物和/或质控物的定值,必须通过已有的高一级的参考测量程序和/或参考物质,保证 其溯源性。”PDF 文件使用 "pdfFactory Pro" 试用版本创建 http://
前言-WHENp 方法/系统首次在实验室使用; p EQA/PT 结果未通过,采取纠正措施后;PDF 文件使用 "pdfFactory Pro" 试用版本创建 http://
前言-WHO & WHEREp 实验室列出方法的性能指标要求(法规或者临床要求); p 实验室选择合适的方法/系统,其性能指标需满足实验室的要求; p 实验室验证分析系统在实验室能否达到厂家的性能指标。PDF 文件使用 "p …… 此处隐藏:3529字,全部文档内容请下载后查看。喜欢就下载吧 ……