常用血栓与止血项目检测试剂批次变更验证程序操作指南  

Operation guide on the verification procedure of new reagent batch for thrombosis and homeostasis routine tests

作　　者：中华医学会检验医学分会 北京医师协会医学检验专科医师(技师)分会 崔巍[2] 王成彬[3] 续薇[4] 寿玮龄[5] 吴卫[5] 高佳[2] 李传保[6] 张洋 Chinese Society of Laboratory Medicine;Beijing Medical Doctor(Technician)Society of Laboratory Medicine;Cui Wei;Wang Chengbin;Xu Wei

机构地区：[1]不详 [2]中国医学科学院肿瘤医院检验科 [3]解放军总医院第一医学中心检验科 [4]吉林大学第一医院检验科 [5]中国医学科学院北京协和医院检验科 [6]北京医院检验科 [7]中国医学科学院阜外医院实验诊断中心

出　　处：《中华检验医学杂志》2021年第10期908-913,共6页Chinese Journal of Laboratory Medicine

摘　　要：常用血栓与止血项目广泛用于出血性疾病诊断、术前筛查、血栓及血栓前状态的判断及抗凝、溶栓药物的监测等。常用血栓与止血项目的检测结果受试剂批次变更影响,而如何进行试剂批次变更的验证、如何识别并判断试剂批次变更导致的检测误差是否在实验室可接受范围,尚无统一标准。中华医学会检验医学分会组织国内同领域专家对上述问题进行了讨论并撰写了指南,以规范常用血栓与止血项目检测试剂批次变更的验证程序。Thrombosis and homeostasis routine tests are widely used in the diagnosis of hemorrhagic diseases,preoperative screening,the judgment of thrombosis and pre-thrombotic state,and the monitoring of anticoagulant and thrombolytic drugs.The results of thrombosis and homeostasis tests can be affected when the batch of reagent is changed.However,so far there is no standard on how to verify the system after the reagent batch change and how to identify the errors caused by the reagent batch change and make a judgment if the errors are acceptable or not according to the laboratory definition.The Chinese Society of Laboratory Medicine organized experienced experts in this field to discuss the problems above and wrote an operation guide which provides recommendations,so as to standardize the verification procedure of new reagent batch for thrombosis and homeostasis tests.

关 键 词：血栓与止血检验质量保证 体外诊断试剂 批次变更 验证 

分 类 号：R446.11[医药卫生—诊断学]