不同血凝分析仪检测结果的一致性研究

目的 探讨不同实验室以及同一实验室的不同血凝分析仪检测结果的一致性.方法 将不同实验室的14台血凝分析仪分为3组,分别为STA系列(A组)、ACL系列(B组)、CA系列(C组),同时检测同一批号不同水平质控品(水平1、2、3)的凝血酶原时间(PT)、国际标准化比值(INR)、活化部分凝血活酶时间(APTT)、纤维蛋白原含量(FIB)及凝血酶时间(TT);并以同一实验室检测原理基本一致的2台血凝分析仪同时检测139份受检血浆的PT、INR、APTT、PT演算法测定FIB(PT-FIB)、Clauss法测定FIB(FIB-C).结果 3组血凝分析仪检测INR水平3的结果分别为5.35±0.20、4.35±1.00、4.46±0.30,差异无统计学意义(P＞0.05);检测TT水平3的结果分别为(17.1±0.3)s、(15.5±1.1)s、(14.8±1.8)s,差异无统计学意义(P＞0.05);其他各检测指标结果间差异有统计学意义(P＜0.05);两两比较的结果表明,B组和C组检测结果的符合率高达66.7%(10/15).同一实验室的ACL Futura和CA 510血凝分析仪检测PT的结果分别为(17.7±6.7)s、(20.1±10.9)s,检测INR的结果分别为1.75±1.07、1.64±0.91,检测PT-FIB的结果分别为(3.51±1.50)g/L、(3.68±1.93)g/L,检测FIB-C的结果分别为(2.61±1.31)g/L、(2.58±1.45)g/L,上述指标间差异均无统计学意义(P＞0.05);而检测APTT的结果分别为(49.9±21.5)s、(39.1±16.7)s,差异具有统计学意义(P＜0.05);同时,二者检测PT、INR、APTT、PT-FIB和FIB-C结果的相关性良好,r值分别为0.984 3、0.988 8,0.987 0,0.975 6,0.994 0;偏倚分析结果显示,2台血凝分析仪检测PT、INR、PT-FIB和FIB-C结果的一致性较好.结论 检测原理基本相同的不同血凝分析仪,其检测结果具有较好的一致性.不同血凝分析仪应通过定期比对和试剂的标准化,以改善和保证其检测结果的一致性.

Harmonization of the results of automated coagulation tests with different analyzers

Objective To investigate the harmonization of results of Prothrombin time(PT),International Normalized Ratio(INR),activated partial thromboplastin time(APTT),fibrinogen(FIB)and thrombin time(TT)with different coagulation analyzers in different or sanle clinical laboratory.Methods PT,INR,Am,FIB and TT for the same quality control material were detected with 14 different coagulation analyzers,which are distributed in 12 clinical laboratories and classified into A,B and C group.MeaJlwhile,PT,INR,APTT,FIB of 139 samples were detected with two different coagulation aJlalyzers in the same laboratory.Results There was no significant difference for detection of level 3 of both INR and TT among the three group analyzers(P＞0.05),but there was significant difference for other tests (P＜0.05).The comparison between groups showed that there was high percentage(66.7%)of consistency for detection of INR,FIB-C and TT between group B and C.The results of two different coagulation analvzers ( ACL Futura and CA 510)in same laboratory showed that there was no significant difference(P＞0.05)for detection of PT,INR,PT-FIB and FIB-C between them,and there was good eorrelation for them in detecting PT,INR,APTT,PT-FIB and FIB-C(r＞0.975).Analysis of bias showed that the bias of PT,INR,PT-FIB and FIBC between the two different coagulation analyzers was acceptable according to CLIA'88.Conclusion There are good agreement for the results between different coagulation analyzers based upon the similar Drinciple in coagulation analysis.