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。
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 Ale （GHbAlc, 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 GHbAlc 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 GHbAlc （ 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 ATIT, 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. 3p.mol/L and 6. 36mmol/L respectively. Conclusion： Instrument is reliable, precision, easy to use and capable of fast sample throughput.
出处
《中国优生与遗传杂志》
2007年第12期34-35,67,共3页
Chinese Journal of Birth Health & Heredity
