血液分析自动审核规则建立与验证的多中心研究  

A multi-center research on the establishment and validation of autoverification rules for blood analysis

作　　者：续薇[1] 郝晓柯 崔巍[3] 江虹[4] 王学锋[5] 屈晨雪[6] 郑磊[7] 杜彦丹 曲林琳[1] 胡恩亮 王剑飚[5] 毛志刚[4] 刘玲玲[1] 郑翠玲[3] 孙德华[7] 普程伟[6] 包春喜 凌励 李强 李覃 Xu Wei;Hao Xiaoke;Cui Wei;Jiang Hong;Wang Xuefeng;Qu Chenxue;Zheng Lei;Du Yandan;Qu Linlin;Hu Enliang;Wang Jianbiao;Mao Zhigang;Liu Lingling;Zheng Cuiling;Sun Dehua;Pu Chengwei;Bao Chunxi;Ling Li;Li Qiang;Li Tan(Department of Clinical Laboratory,the First Hospital of Jinlin University,Changchun 130021,China)

机构地区：[1]吉林大学第一医院检验科,长春130021 [2]空军军医大学西京医院检验科 [3]中国医学科学院肿瘤医院检验科 [4]四川大学华西医院检验科 [5]上海交通大学医学院附属瑞金医院检验科 [6]北京大学第一医院检验科 [7]南方医科大学南方医院检验科 [8]内蒙古林业总医院检验科 [9]希森美康医用电子(上海)有限公司

出　　处：《中华检验医学杂志》2018年第8期601-607,共7页Chinese Journal of Laboratory Medicine

摘　　要：目的 建立可用于血液分析检验结果自动审核的规则,为血液分析不同检测系统提供建立和验证自动审核规则的思路,在保证检验质量的同时缩短TAT时间.方法 多中心研究收集来自吉林大学第一医院等八家医院检验科2017年1月至11月期间的EDTA-K2抗凝血常规样本共34629例：规则建立组3478例,其中差值检查（Delta check）288例;规则验证组5362例,其中Delta check 2494例;临床试应用组25789例.应用Sysmex XN系列全自动血液分析仪检测血常规,同时制备血涂片、染色、镜检,将临床信息、设备参数、检测结果和镜检结果汇总;利用统计学方法筛选自动审核条件（包括项目和cut-off值）;将自动审核条件录入仪器软件;进行模拟条件的一期验证以及检测后样本二期验证,分别计算真阴性、假阴性、真阳性、假阳性、自动审核通过率和通过正确率;应用确定的自动审核条件自动审核血常规结果验证漏检率、得出自动审核通过率和TAT时间.结果 （1）自动审核规则涉及白细胞、红细胞、血小板、Delta check及性状异常共43条.（2）规则建立组中3190例样本其假阴性为1.94%（62/3190）（P〈0.001）,自动审核通过率为76.74%、通过正确率为97.47%;规则验证组中2868例样本其假阴性为3.38%（97/2868）（P=0.002）,自动审核通过率为42.26%、通过正确率为92.00%;规则建立组288例和规则验证组2494例Delta check假阴性分别为1.39%和2.61%（P〈0.001）.（3）三家医院试应用自动审核规则,检测的25789例血常规样本,检验结果报告平均TAT缩短分别为24、32、7 min,30 min内发报告率分别提高33%、53%和7%,自动核通过率为72%~74%.结论 应用血液分析自动审核规则43条能够在保证检验质量的同时缩短TAT,提高血常规检验工作效率.值得指出的是,在临床应用时,对于与本研究相同型号的检测系统,应用前应进行验证,并在应用中做周期性验证;对于不Objective To establish a set of rules for autoverification of blood analysis, in order to provide a way to validate autoverifieation rules for different analytical systems, which can ensure the accuracy of test results as well as shorten turnaround time （TAT） of test reports. Methods A total of＂ 34 629 EDTA- K2 antieoagulated blood samples were collected from umlticenter cooperative units including the First Hospital of Jinlin University during January 2017 to November 2017. These samples included： 3 478 cases in Autoverification Establishment Croup, including 288 cases for Delta check rules; 5 362 cases in Autoverification Validation Croup, including 2 494 cases for Delta check; 25 789 cases in Clinical Application Trial Group. All these samples were analyzed for blood routine tests using Sysmex XN series automatic blood analyzers. Blood smears, staining and microscopic examination were done for each sample; then the clinical information, instrument parameters, test results and microscopic results were summarized; screening and determination of autoverification conditions including parameters and cutoff values were done using statistical analysis. The autoverifieation rules were input into Sysmex Laboman software and undergone stage Ⅰ validation using simulated data, and stage Ⅱ validation for post-analytical samples successively. True negative, false negative, true positive, false positive, autoverifieation pass rate and passing accuracy were calculated. Autoverifieation rules were applied to autoverification blood routine results and missed detection rates were validated, and also data of autoverification pass rate and TAT were obtained. Results （ 1 ） The selected autoverifieation conditions and cutoff values included 43 rules involving WBC, RBC, PLT, Delta check and abnormal characteristics. （2）Validation of 3 190 cases in Autoverification Establishment Group showed the false negative rate was 1.94% （62/3 190） （P 〈 0. 001 ） , autoverification pass rate was 76.74% , passing accura

关 键 词：自动审核规则 血液分析 验证 TAT 漏检率 

分 类 号：R446.1[医药卫生—诊断学]