MC500全自动凝血分析仪性能评估  

Assessment of the performance of MC500 full automatic blood coagulation analyzer

作　　者：邵玲俐 邵杰 刘岩[1] 何露 SHAO Ling-li;SHAO Jie;LIU Yan(Clinical Laboratory,Northern Institute of Peking University Third Hospital,Department of Laboratory Medicine,Beijing Northern Hospital of Weaponry Industry,Beijing 100089,China;不详)

机构地区：[1]北京大学第三医院北方院区检验科,北京100089 [2]兵器工业北京北方医院检验科,北京100089

出　　处：《中国医学装备》2021年第8期47-51,共5页China Medical Equipment

摘　　要：目的:评估MC500全自动凝血分析仪的性能,为临床提供准确报告。方法:在保证MC500全自动凝血分析仪检测系统良好的状态下,参照TOP700全自动凝血分析仪对MC500全自动凝血分析仪的精密度、携带污染率、线性、结果一致性评价和普施康APTT试剂对凝血因子的敏感性等进行性能评估,采用新鲜血标本,选取TOP700已检测完成的含有50%为阳性凝血标本进行比对。结果:在MC500全自动凝血分析仪精密度中,混合新鲜血的活化部分凝血酶时间(APTT)为2.13%、凝血酶原时间(PT)为1.58%、凝血酶时间(TT)为4.99%、纤维蛋白原(FIB)为4.63%、D-二聚体(D-D)为3.69%;混合高值质量控制,APTT、PT、TT、FIB和DD分别为4.01%、1.60%、4.39%、2.10%和4.47%;携带污染率中PT、APTT、FIB和D-D分别为0.7%、0.5%、3.02%和1.6%,均符合厂家要求。FIB线性范围0.7~9.00 g/L,r=0.999;DD线性范围0~20.00μg/ml,r=0.998,均符合厂家及临床要求。MC500与TOP700各项目相关性良好。普施康APTT试剂对Ⅷ因子、Ⅸ因子、Ⅺ因子、Ⅻ因子、Ⅴ因子和Ⅹ因子的灵敏度分别为40%、40%、40%、30%、30%和20%。结论:MC500全自动凝血分析仪精密度良好、携带污染率低、线性符合厂家及临床的需求,且与TOP700相关性良好,是一款检测性能稳定且检测结果可靠的凝血分析仪。Objective:To assess the performance of MC500 full automatic blood coagulation analyzer for providing accurate clinical report.Methods:The precision,carryover rate,linearity,result consistency and the sensitivity of Pushkang APTT reagent on factors of MC500 full automatic blood coagulation analyzer were assessed by referring to TOP700 full automatic blood coagulation analyzer under the situation of ensuring favorable detection system of MC500 full automatic blood coagulation analyzer.The fresh blood specimens were adopted,and the specimens that had been tested by TOP700 and included positive coagulation specimens that were 50%of total specimens were selected.Results:The precision results of MC500 full automatic blood coagulation analyzer indicated the precisions of activated partial thromboplastin time(APTT),prothrombin time(PT),thrombin time(TT)and fibrinogen(FIB)and D-dimer(DD)were 2.13%,1.58%,4.99%,4.63%and 3.69%in mixed fresh blood,respectively.And the precisions of APTT,PT,TT,FIB and DD of mixed high-value quality control were 4.01%,1.60%,4.39%,2.10%and 4.47%,respectively.The carryover rates of PT,APTT,FIB and DD were 0.7%,0.5%,3.02%and 1.6%,respectively.All of them could meet the requirements of manufacturers.Linearity range of FIB was 0.7-9.0 g/L,r=0.999.And linearity range of DD was 0-20μg/ml,r=0.998.And all of them met the requirements of manufacturer and clinical practice.In addition,the correlation of each item between MC500 and TOP700 was favorable.The sensitivities of Pushkang APTT reagent onⅧfactor,Ⅸfactor,Ⅺfactor,Ⅻfactor,Ⅴfactor andⅩfactor were 40%,40%,40%,30%,30%and 20%,respectively.Conclusion:MC500 full automatic blood coagulation analyzer has favorable precision and low carryover rate,and the linearity of that conformed with the requirements of manufacturer and clinical practice,and the correlation between that and TOP700 is favorable.It is a favorable blood coagulation analyzer with stable detection performance and reliable detection result.

关 键 词：性能评估 全自动凝血分析仪 检测 

分 类 号：R197.39[医药卫生—卫生事业管理]