Destiny Max全自动血凝分析仪性能评价

目的:对Destiny Max全自动血凝分析仪的机械法检测系统进行性能评价。方法:选择凝血酶原时间(PT)、部分活化凝血酶原时间(APTT)、凝血酶时间(TT)和纤维蛋白原(FIB)浓度4个指标,采用机械式磁珠法检测对准确性、精密度和携带污染率进行实验评价,并与STR-Evolution上所测结果进行相关性和Kappa一致性检验分析。结果:TriniCHECK Control 1在Destiny Max全自动血凝仪上测定的PT、APTT、TT、FIB的准确性偏差分别为2.21%、2.57%、4.68%、4.72%;TriniCHECK Control 2测定的PT、APTT、FIB准确性偏差分别为1.96%、0.54%、3.46%,精密度分别为1.33%、1.90%、3.54%;FIB高值携带污染率为2.56%,FIB对PT试剂携带污染率为2.15%;Destiny Max与STR-Evo-lution全自动血凝分析仪的临床标本比对结果良好,线性相关系数均大于0.95,K值均大于0.8,P值大于0.05,无统计学差异。结论:Destiny Max全自动血凝仪的准确性、精密度以及携带污染率都达到了性能要求,并且与STR-Evolution的临床标本比对结果有很好的相关性和一致性,可为临床提供可靠的检测数据。

Performance Evaluation of Destiny Max Automatic Coagulation Analyzer

Objective To evaluate the detection system performance of mechanical method of Destiny Max automatic coagulation analyzer.Methods Mechanical method was selected,and prothrombin time（PT）,activated partial thromboplastin time（APTT）,thrombin time and fibrinogen（FIB） were used to evaluate the accuracy,precision and carry over rate.The sample test results were compared with STR-Evolution,and then the correlation and Kappa consistency analysis were evaluated.Results The accuracy deviation of PT,APTT,TT and FIB tested with TriniCHECK Control 1 on Destiny Max were 2.21%,2.57%,4.68% and 4.72%.The accuracy deviation of PT,APTT and FIB tested with TriniCHECK Control 2 were 1.96%,0.54% and 3.46%,and the precision were 1.33%,1.90% and 3.54%,respectively.The carry over rate of FIB high value was 2.56%,and that of FIB to PT reagent was 2.15%.The clinical sample results comparison between Destiny Max and STR-Evolution was favorable,the linear correlation coefficient r0.95,K0.8,P0.05,and with no significant difference.Conclusion The accuracy,precision and carry over rate of Destiny Max all have reached the performance requirements,and the clinical results compared to STR-Evolution have good relevance and consistency,so Destiny Max automatic coagulation analyzer could provide reliable test results for clinic.[Chinese Medical Equipment Journal,2012,33（6）：107-109]