全自动血凝分析仪性能验证及结果比对  

Performance verification and results testing for Automatic blood coagulation analyzer

作　　者：刘英杰[1] 夏西燕 LIU Yingjie;XIA Xiyan(Department of Clinical Laboratory,Qilu Hospital of Shandong University,Ji′nan,Shangdong 250012,China;Department of Immunology,Ji′nan Nursing Vocational College,Ji′nan,Shangdong 250102,China)

机构地区：[1]山东大学齐鲁医院检验科,山东济南250012 [2]济南职业护理学院免疫教研室,山东济南250102

出　　处：《检验医学与临床》2021年第5期628-631,共4页Laboratory Medicine and Clinic

摘　　要：目的评价新投入临床使用的1台全自动血凝分析仪(STA-R Max)性能,并与现用的全自动血凝分析仪(STA-R Evolution)进行结果比对分析。方法在2台全自动血凝分析仪上检测凝血四项[凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、纤维蛋白原(FIB)和凝血酶时间(TT)],对检测结果进行比对分析,并对新的全自动血凝分析仪精密度、线性范围和携带污染率等进行评价。结果在新的全自动血凝分析仪上重复测定正常和异常混合血浆的批间精密度,PT分别为1.12%和1.46%,APTT为0.94%和1.59%,FIB为1.83%和4.13%,TT为0.87%;批内精密度,PT为0.72%和0.44%,APTT为0.39%和0.65%,FIB为1.37%和1.75%,TT为0.87%;携带污染率为0.17%;FIB的实际检测值与理论值的线性回归方程为Y=0.9929 X-0.0937(P>0.05),截距与0之间比较差异无统计学意义(P>0.05),直线斜率与1之间比较差异无统计学意义(P>0.05);2台仪器相关性分析:PT、APTT、FIB和TT的测定结果r值分别为0.9896、0.9840、0.9951和0.9619,相对偏差分别为1.91%、2.73%、0.29%、1.51%,小于美国临床实验室改进修正法规(CLIA′88)规定的允许误差。2台全自动血凝分析仪凝血四项检测结果比较,差异均无统计学意义(P>0.05)。结论新投入使用的全自动血凝分析仪具有良好的重复性、稳定性、线性和携带污染率,2台全自动血凝分析仪结果一致,有良好的相关性,均可用于临床标本检测。Objective To evaluate the performance of a newly installed automatic coagulation analyzer(STA-R Max)and compare the consistency of its testing results with the confirmed clinical automatic coagulation analyzer(STA-R Evolution).Methods Four items of blood coagulation[prothrombin time(PT),activation partial thrombin time(APTT),fibrinogen(FIB)and thrombin time(TT)]were detected on two sets of automatic coagulation analyzers.The results were compared and analyzed,and the precision,linear range and contamination rate of the new hemagglutination analyzers were evaluated.Results For the newly installed automatic coagulation analyzer,the relative inter-precision of normal and abnormal mixed plasma were:1.12%and 1.46%for PT,0.94%and 1.59%for APTT,1.83%and 4.13%for FIB,0.87%for TT respectively.Intra-precision were:0.72%and 0.44%for PT,0.39%and 0.65%for APTT,1.37%and 1.75%for FIB,0.87%for TT respectively.The carryover was 0.17%.The linear regression equation of FIB actual and theoretical values was Y=0.9929 X-0.0937(P>0.05).There was no significant statistical difference between the intercept and 0(P>0.05)and between linear slope and 1(P>0.05).PT,APTT,FIB and TT have good correlation(r=0.9896,0.9840,0.9951 and 0.9619)between two analyzers.The testing results of bias of PT,APTT,FIB and TT for two analyzers were 1.91%,2.73%,0.29%,1.51%within the acceptable defined bias in CLIA′88.Comparison of four items of blood coagulation results between two sets of automatic coagulation analyzers showed no statistically significant difference(P>0.05).Conclusion The newly put into use automatic coagulation analyzer has good repeatability,stability,linearity and carrying contamination rate.The results of two hemagglutination analyzers are consistent and have good correlation,both of which can be used for clinical specimen detection.

关 键 词：血凝分析仪 性能验证 相关性 

分 类 号：R446.11[医药卫生—诊断学]