72例患者用国产与进口试剂在TEG5000检测的结果对比

A Comparative Study of the Results of 72 Patients Using Domestic and Imported Thromboelastography Reagents in TEG5000

目的本研究旨在通过比对重庆鼎润试剂(国产)与原装试剂(进口)在TEG5000血栓弹力图仪上的检测结果,探讨该国产试剂在本实验室血栓弹力图(thromboelas-stogram,TEG)诊断和监测凝血异常治疗方面的价值。方法用国产试剂与进口试剂在TEG5000上同时检测72份患者样本的TEG参数值,并收集72份样本凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、纤维蛋白原(FIB)、血小板计数(PLT)的结果,对两种试剂TEG检测反应时间(R)、凝血时间(K)、α角(Angleα)和最大振幅(MA)等参数结果的一致性以及TEG检测参数与常规凝血检测结果的相关性进行统计学分析。结果国产与进口两组试剂的TEG检测参数R、K、α角和MA等比较差异无统计学意义,P>0.05。将72份样本按患者疾病进行分组,5组不同诊断的患者标本使用国产与进口试剂检测结果比较,R值、K值、Angleα、MA值结果一致,差异无统计学意义,P>0.05。与常规凝血检测结果的相关性分析中,两组试剂的R与常规凝血检测中的PT和APTT值具有较强的相关性,P<0.05。两组试剂的K值与常规检测中的FIB和PLT有相关性,P<0.05。两组试剂的α角与常规检测中的FIB和PLT具有较强相关性,P<0.05。两组试剂的MA值与常规检测中的PT、FIB、PLT均有相关性,P<0.05。结论国产试剂在TEG5000上的检测结果与进口试剂准确性一致,与常规凝血检测结果具有较强相关性,可以满足临床检测使用。本研究也为其他医疗机构选用相关国产试剂提供了有价值的基础数据参考。

Objective The purpose of this study was to compare the test results of Chongqing Dingrun kit(made in China)and an imported kit on TEG5000 thromboelastography(TEG)instrument,and to validate this domestic reagent in diagnosing and monitoring the treatment of coagulation dysfunction in our laboratory.Methods TEG parameter values of 72 samples were detected simultaneously on TEG5000 with both domestic and imported reagents.The agreement between the domestic kit and imported reagent was examined using TEG variable parameters,including:R,K values,αangle and maximal amplitude(MA).The results of prothrombin time(PT),activated partial thromboplastin time(APTT),fibrinogen(FIB)and platelet count(PLT)were collected from 72 samples and the correlation between TEG parameters and results of routine coagulation tests was analyzed statistically.Results There was no significant difference in R,K,Angleαand MA between the domestic and imported reagents.(P>0.05).Seventy-two samples were divided into multiple groups based on disease types.The results of the five groups of patients with different diagnoses were compared with those of domestic and imported reagents.The results of R,K,Angleαand MA were consistent with no significant difference(P>0.05).In the correlation analysis with the results of conventional coagulation tests,the R values of the two groups of reagents had a strong correlation with the PT and APTT values of conventional coagulation tests(P<0.05).K values of the two groups of reagents were correlated with FIB and PLT in routine tests(P<0.05).Angle values of the two groups of reagents were correlated with FIB and PLT in routine tests(P<0.05).MA values of the two groups of reagents were correlated with PT,FIB and PLT in routine detection(P<0.05).Conclusion The test results of domestic reagents on the TEG5000 are consistent with the accuracy of imported reagents,and have a strong correlation with conventional coagulation test results,which appears to be highly reliable for use in clinical application.This study also provides valuable basic data-driven reference for other medical institutions to select relevant domestic reagents.