ExC810全自动凝血分析仪检测APTT、PT、TT及FIB性能验证及与ACL-TOP700比对分析  

Performance verification of ExC810 coagulation analyzer for APTT,PT,TT,and FIB and comparative analysis with ACL-TOP700

作　　者：邓婷婷 庄丽颖 刘爱胜 DENG Ting-ting;ZHUANG Li-ying;LIU Ai-sheng(Department of Clinical Laboratory,Shenzhen Longhua District People’s Hospital,Shenzhen 518109,Guangdong,China)

机构地区：[1]深圳市龙华区人民医院检验科,广东深圳518109

出　　处：《生物医学工程与临床》2025年第1期110-114,共5页Biomedical Engineering and Clinical Medicine

摘　　要：目的对Ex C810全自动凝血分析仪(简称ExC810)各项性能进行验证,并与ACL-TOP700全自动凝血分析仪(简称ACL-TOP700)进行比对,评价Ex C810各项性能是否满足临床质量要求。方法参照中国凝血仪医药行业标准YY/T0659—2017、WS/T 406—2012及美国临床和实验室标准协会(CLSI)制定的性能验证相关评价方案和标准,对Ex C810检测活化部分凝血活酶时间(APTT)、凝血酶原时间(PT)、凝血酶时间(TT)、纤维蛋白原(FIB)及D-二聚体(DD)的精密度、准确度、携带污染率(CPR)及线性进行评价,并将ExC810检测结果与用于室间质评的TOP700进行比对。结果ExC810检测正常值样本APTT、PT、TT、FIB及DD的批内变异系数(CV)分别为1.00%、0.90%、0.80%、2.02%及2.55%,异常值样本分别为1.59%、1.17%、1.99%、1.65%及3.07%;ExC810检测APTT、PT、TT、FIB及DD准确度的相对偏倚(Bias)分别为1.38%、1.73%、0.70%、-1.08%和2.83%;ExC810检测APTT、PT、TT、FIB及DD的线性分别为0.9826、0.9901、0.9927、0.9990、0.9929,均大于厂家要求>0.98;ExC810检测APTT、PT、TT、FIB及DD的CPR分别为-0.09%、-1.85%、0.36%、0.00%、2.27%,表明该仪器检测上述指标污染率很低;ExC810检测APTT和PT的结果与ACL-TOP700基本一致,差异无统计学意义(P>0.05);而TT和FIB的结果明显高于ACL-TOP700,DD结果明显低于ACL-TOP700,差异有统计学意义(P<0.05);ExC810检测APTT、PT、TT及FIB的结果与ACL-TOP700具有良好的相关性,相关系数(r)分别为0.9135、0.9770、0.9601、0.8854,而DD结果相关性差(r=0.4602)。结论ExC810分析仪具有良好的重复性、准确度、线性及携带污染率低,且与ACL-TOP700具有良好的相关性,可满足临床质量要求。但两台仪器检测的TT和FIB结果存在明显差异,需进行校正,确保不同仪器结果的一致性。Objective To verify the performance of ExC810 automatic coagulation analyzer(abbreviation:ExC810)and compare with ACL-TOP700 automatic coagulation analyzer(abbreviation:ACL-TOP700),and evaluate the compliance of ExC810 performance with clinical quality requirement.Methods According to China Coagulation Instrument Pharmaceutical Industry Standard YY/T0659—2017,WS/T 406—2012 and relevant evaluation schemes and standards for performance verification formulated by American Clinical and Laboratory Standards Institute(CLSI),the precision,accuracy,carrying pollution rate(CPR)and linearity of activated partial thromboplastin time(APTT),prothrombin time(PT),thrombin time(TT),fibrinogen(FIB)and D-dimer(DD)detected by ExC810 were evaluated,and the results of ExC810 were compared with that of ACL-TOP700 for inter-ventricular quality assessment.Results The same batch coefficient of variation(CV)of APTT,PT,TT,FIB and DD in normal samples detected by ExC810 were 1.00%,0.90%,0.80%,2.02%and 2.55%,respectively,and that in abnormal samples were 1.59%,1.17%,1.99%,1.65%and 3.07%,respectively.The relative bias(Bias)of ExC810 for APTT,PT,TT,FIB and DD were 1.38%,1.73%,0.70%,-1.08%and 2.83%,respectively.The linearity of APTT,PT,TT,FIB and DD detected by ExC810 were 0.9826,0.9901,0.9927,0.9990 and 0.9929,respectively,which were greater than the requirements of manufacturers(>0.98).The CPR of APTT,PT,TT,FIB and DD detected by ExC810 were-0.09%,-1.85%,0.36%,0.00%and 2.27%,respectively,which showed that CPR of the instrument was very low.The results of APTT and PT detected by ExC810 were basically consistent with those of ACL-TOP700,which was no statistically significant(P>0.05),while the results of TT and FIB were significantly higher than those of ACL-TOP700,and results of DD were significantly lower than those of ACL-TOP700,which was statistically significant(P<0.05).The results of APTT,PT,TT and FIB detected by ExC810 showed good correlation with those of TOP700,and correlation coefficients(r)were 0.9135,0.9770,0.9601 and 0.8854,res

关 键 词：Ex C810分析仪 ACL-TOP700分析仪 凝血功能 性能验证 结果比对 相关性 

分 类 号：R446.11[医药卫生—诊断学]