凝血因子的临床检测性能评价  

Evaluation of the clinical detection performance of blood coagulation factors

作　　者：刘文[1,2] 费中海[1,2] 万松 王洪友[1,2] 蒲劲 韩学婷[3] LIU Wen;FEI Zhonghai;WAN Song;WANG Hongyou;PU Jin;HAN Xueting(Department of Clinical Laboratory,Affiliated Hospital of North Sichuan Medical College,Nanchong,Sichuan 637000,China;Department of Laboratory Medicine,the North Sichuan Medical College,Nanchong,Sichuan 637000,China;Sekisui medical technology(China)Ltd.,Chengdu,Sichuan 610000,China)

机构地区：[1]川北医学院附属医院检验科,四川南充637000 [2]川北医学院检验系,四川南充637000 [3]积水医疗科技(中国)有限公司,四川成都610000

出　　处：《检验医学与临床》2022年第S02期54-56,共3页Laboratory Medicine and Clinic

摘　　要：目的对血浆凝血因子活性检测项目进行全面性能评价,以期为临床提供可靠的检测结果。方法对本试验Coapresta 3000全自动凝血分析仪测定凝血因子(FⅡ、FⅤ、FⅦ、FⅧ、FⅨ、FⅩ、FⅪ、FⅫ)活性的批内精密度、正确度、最小检测限、可报告范围、线性范围、系统间比对、携带污染率进行全面性能评估。结果8个凝血因子批内精密度为1.21%~5.19%;凝血因子(FⅤ、FⅨ)的正确度相对偏差均小于15%;凝血因子(FⅤ、FⅨ)的最小检测限分别为6.03%和1.60%;凝血因子(FⅤ、FⅨ)的最大稀释倍数分别可达64倍,其最大可报告范围可达6400%;凝血因子(FⅤ、FⅨ)的线性范围评估数据组中无明显离群值,线性相关系数在0.9907~0.9943;CP3000与参比系统比较一致性较好,FⅤ的r为0.9826,FⅨ的r为0.9731;凝血因子(FⅤ、FⅨ)的携带污染率分别为0.36%和-3.01%。结论Coapresta 3000全自动凝血分析仪凝血因子检测批内精密度、线性范围及携带污染率等性能评价结果良好,可适用于临床标本的检测。Objective To conduct a comprehensive performance evaluation of full coagulation analyzer in testing coagulation factors,in order to provide reliable test results for clinic.Methods To evaluate within-run imprecisions,trueness,minimum detection limit,accuracy reportable range,linear range,comparability,carry out comprehensive of the Coapresta 3000 coagulation analyzer.Results The within-run imprecisions of 8 coagulation factors were 1.21% to 5.19%,the relative deviation of the correctness of coagulation factors(FⅤ,FⅨ)was less than 15%,the minimum detection limits of coagulation factors(FⅤ,FⅨ)were 6.03% and 1.60%,the maximum dilution ratio of coagulation factor(FⅤ,FⅨ)can reach 64 times respectively,and the maximum reportable range can reach 6400%,there was no significant outlier in the linear range evaluation data group of coagulation factors(FⅤ,FⅨ),and the linear correlation coefficient was between 0.9907 to 0.9943,were both more than 0.975;Coapresta 3000 has a good consistency with the reference system,the correlation coefficient of FⅤis 0.9826,and the correlation coefficient of FⅨ is 0.9731;the carry out comprehensive of coagulation factors(FⅤ,FⅨ)were 0.36% and-3.01%.Conclusion Coapresta 3000 coagulation analyzer has a good perfomance in within-run imprecisions,accuracy,minimum detection limit,accuracy reportable range,linear range,carry out comprehensive.It is suitabe for detection of clinical specimens.

关 键 词：凝血因子 性能 血浆 

分 类 号：R446.1[医药卫生—诊断学]