性能验证(长沙).pdf

性能验证 ——定量检测系统 北京医院 肖路延 Email:xiaoly_66@ 性能验证程序(SOP)  Why –为什么要做？  when – 什么时候需要做？  who –谁来做？  Where—在哪儿做？  what—做什么？ how—怎样做？ The U.S. CLIA Rules Sec. 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 the following performance characteristics: (A) Accuracy (B) Precision (C) Reportable range of test results for the test system (ii) Verify that the manufacturers reference intervals (normal values) are appropriate for the laboratorys 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 inhouse 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: (i) Accuracy. (ii) Precision. (iii) Analytical sensitivity. (iv) Analytical specificity to include interfering substances. (v) Reportable range of test results for the te