凝血分析仪自动审核方案的建立与评价  

The Development and Evaluation of Automatic VerificationSystem Automatic Blood Coagulation Analyzer

作　　者：何恩萍 吕兆吉 李忠承 全晖 HE Enping;LYU Zhaoji;LI Zhongcheng;QUAN Hui(Department of Clinical Laboratory,the Second Affiliated Hospital of Chengdu Medical College,Nuclear Industry 416 Hospital,Chengdu 610051,China)

机构地区：[1]成都医学院第二附属医院·核工业四一六医院检验科,四川成都610051

出　　处：《标记免疫分析与临床》2023年第6期1057-1065,共9页Labeled Immunoassays and Clinical Medicine

摘　　要：目的建立凝血自动审核方案,验证并实际应用于临床工作。方法收集核工业四一六医院7186份(含413份Delta Check组)凝血标本进行审核规则的建立,3483份(含411份Delta Check组)标本进行自动审核规则的验证。以上使用样本根据年龄分为青年组(1~18岁)、中年组(19~59岁)与老年组(60岁以上)。使用Sysmex CS-5100凝血分析仪进行样本的检测,得到的结果在LIS软件中根据预设的审核规则自动判断,结合人工审核,分别计算建立组与验证组的阳性符合率、阴性符合率、假阴性率、假阳性率、自动审核通过率与通过正确率。结果共建立自动审核规则35条,涉及检验项目共11项。建立组的自动审核通过5044份,自动审核通过率为70.19%,人工与自动审核一致率为98.87%,阳性符合率与阴性符合率分别为28.68%与70.19%;验证组的自动审核通过2270份,自动审核通过率为65.17%,人工与自动审核一致率为98.77%,阳性符合率与阴性符合率分别为33.60%与64.86%。老年组的自动审核通过率最低,有效拦截率最高。结论本研究建立的35条自动审核规则,可以针对不同年龄段的样本进行高效判断,使问题结果得到拦截。Objective To establish and validate an auto-verification system for blood coagulation tests and apply it for clinical practice.Methods A total of 7186 coagulation samples(including 413 samples for Delta Checkrules)from Nuclear Industry 416 Hospital were collected to establish verification rules,while 3483 samples(including 411 samples for Delta Check rules)were selected to validate rules.We divided these samples into Youth group(0-18 years old),Adult group(19-59 years old)and Elderly group(over 60 years old)according to patient age.Samples were analyzed for coagulation tests using Sysmex CS-5100 automatic coagulation analyzer,and the results were checked automatically by the preset rules in LIS.Establish group and validation group positive coincidence,negative coincidence,false negative,false positive,auto-verification pass rate and passing accuracy were calculated after manual check.Results A total of 35 auto-verification rules were established which involved 11 test terms.In the establish group,5,044 samples were verified automatically:auto-verification pass rate was 70.19%,and passing accuracy was 98.87%,in which positive coincidence and negative coincidence were 28.68%and 70.19%,respectively.In the validation group,2270 samples were verified automatically:auto-verification pass rate was 65.17%,and passing accuracy was 98.77%,in which positive coincidence and negative coincidence were 33.60%and 64.86%,respectively.The elderly group had the lowest auto-verification passing rate and the highest passing accuracy.Conclusion The 35 auto-verification rules are established in this study,which can check sample’results of different ages efficiently,and intercept potential wrong results.

关 键 词：凝血实验 自动审核 审核规则 

分 类 号：R-331[医药卫生]