【李金明】临床分子检测：性能验证与性能确认.pdf

临床分子检测：性能验证与性能确认 李金明 国家卫生计生委临床检验中心 ？  性能验证（verification ）？  性能确认（validation ）？  性能验证与性能确认有何区别？  性能验证的5W （Why 、What 、When 、 Where 、Who）1H （How）？  LDTs及其国内外监管？ “性能验证”（“verification”）定义  “verification”：broadly as “confirmation through the provision of objective evidence, that specified requirements have been fulfilled” . （广义为通过提供客观证据证明特定 的要求得到满足）  CLIA uses the term “verification”：specifically to relate to confirmation that the laboratory using a test can replicate the manufacturer ’s performance claims when the test is used according to the package insert. （CLIA性能验证术语特指 使用某特定检测试剂或系统的实验室按照所提供的试 剂盒或检测系统说明书使用时，能复现生产厂家 所宣称的检测性能。） “性能确认”（“validation” ）定义  The FDA and ISO both define the term “validation”as “confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled” . （通过检查和提供客观证据证明，对一特 定预期应用的要求始终能得到满足）  The FDA and ISO terms for verification and are similar, with the distinction having to do with intended use. （性能验证和性能确认 FDA和ISO术语相似，差异在后者的“预期 用途”） “intended use”预期用途  The term “intended use”in these documents is established by the manufacturer or developing laboratory at the time of assay development and has to do with the purpose and population for which the test was intended (e.g., diagnosis, following treatment, etc.). Relevant performance characteristics are then determined based on the intended use of the test.  Some people interpret “intended use”as referring to the relevant clinical laboratory in which the test is performed, rather than the manufacturer or developing laboratory, thus causing confusion. The World Health Organization (WHO) defines validation as “the action (or process) of proving that a procedure, process, system equipment or method used