【摘要】 目的对ACL-Futura血液凝固分析仪的性能进行评价,为各实验室选用提供参考。方法选择PT、APTT、Fbg(Clauss法)、Fbg(Derived法)和糖化血红蛋白A1c(GHbA1c,乳胶凝集法)等5个项目,用质控血浆和病人样本对该仪器的检测重复性、稳定性、准确性、线性和抗生物性干扰物能力等方面进行了初步评价。结果日内CV%凝固法最高是2.4%;乳胶凝集法为4.4%。日间CV%凝固法最高是3.8%;乳胶凝集法为7.6%。相对平均偏差除APTT为3.9%外,其余都在1%以内;Fbg-C和Fbg-D和GHbA1c的浓度与反应信号的相关系数均为0.999;APTT秒数和PT秒数与样本稀释度间的相关系数分别是0.9997和0.9995;均有非常显著的相关关系(P<0.01)。加入不同浓度的高胆红素、高甘油三酯血清和血红蛋白液干扰反应时相对平均偏差在-6.1%至5.5%。结论ACL-FUTURA血液凝固仪具有重复性好,稳定性强,准确度高,线性范围宽和抗生物性干扰物能力强等特点;且操作方便,运行速度快,检测项目随时任选,具有较强的科研能力和很大的开发潜力,十分适合于我国大中型医院使用。更多还原

【Abstract】 Objective: To evaluate the technical performance of the ACL-Futura coagulation analyzer.And to provide data for various laboratories in the selection of coagulation analyzer.Methods: To co-evaluated the following assay:Prothrombin time(PT),Activated partial thromboplaslin time(APTT),Fibrinogen-C(Fbg-C,Clauss method),Fibrinogen-D(Fbg-D,Derived method) and Glycated Hemoglobin A1c(GHbA1c,Lactic-gel agglomerate method).The precision,stability,accuracy,linearity and interferences were assessed.Results:The analyzer shows an within-between day imprecision with normal control plasma,for PT of 1.0 to 1.3%,APTT of 1.8 to 3.8%,Fibrinogen-C of 2.4 to 3.3%,Fibrinogen-D of 1.4 to 1.5% and GHbA1c of 4.4 to 7.6% respectively.The calibration curves were linear within the concentration range of 1.75-5.31mg/L for Fbg-C,0.67-2.67mg/L for Fbg-D and 1.44-14.4 for GHbA1c(r>0.998,P<0.01).In addition,the correlation between the dilution of sample and the result(second) of APTT and PT is good(n=6,r>0.999,P<0.01).Experimental results also show that relative deviations of ATTT,PT,Fbg-C and Fbg-D were 3.9%,0.6%.0.6% and 0.4% respectively.It is not significantly affected by such biological products as haemoglobin,bilirubin and triglycerides up to 4.0g/L,127.3μmol/L and 6.36mmol/L respectively.Conclusion: Instrument is reliable,precision,easy to use and capable of fast sample throughput.更多还原