目的：评价 ACL TOP 血凝仪在儿科实验室的性能及应用。方法：参照 CLSI 的要求，评价 ACL TOP血凝仪的精密度、正确度、线性、抗生物干扰能力、样本携带污染率；建立 ACL TOP 血凝仪在本地区儿童的凝血酶原时间（PT）、活化部分凝血活酶时间（APTT）、凝血酶时间（TT）、纤维蛋白原（FIB）的参考区间。结果：凝固法及免疫比浊法两种方法的精密度均符合厂家规定的要求；正确度实验PT、APTT、FIB的偏倚均未超出二分之一 CLIA′88规定的允许误差范围；FIB 线性测定的直线回归方程为 Y ＝1．0021X-0．122，R2为0．9982，符合厂家要求（r≥0．975）；胆红素20 mg/dL、甘油三脂900 mg/dL、血红蛋白5 g/L 时，对 PT、APTT、TT 和 FIB 测定的影响度均小于二分之一 CLIA′88规定的允许误差范围；样本携带污染率最高为1．81％，符合厂家性能要求；本地区儿童生物参考区间：PT（9．1～13．1 s）、APTT（24．9～42．1 s）、TT（12．6～21．1 s）、FIB（1．924～4．011 g/L）。结论：ACL TOP血凝仪具有良好的精密度、正确度、线性和较低的样本携带污染率，并具较强的抗生物干扰能力，适合本实验室使用。%Objective To evaluate the performance of ACL TOP coagulation analyzer system in the laboratory of children′s hospital. Methods According to the documents of CLSI, the analytic characteristics including precision, accuracy, linearity, interference and carryover rate were examined; specimens from healthy children were collected and assayed to determine the reference range of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Thrombin Time (TT), Fibrinogen (FIB) and D-Dimer (D-D) from children on ACL TOP. Results The within-run and between-day coefficient of variability (CV) were within an acceptable range; The accuracy deviation of PT , APTT and FIB were less than 1/2 allowed total errors; The results of determination of FIB linearity test were correlated with the results of calculation: Y = 1.002 1X-0.122, R2 =0.998 2; The extent of influence of low to middle grade of jaundice , fat and hemolysis on each test were all less than 1/2 allowed total error; The carryover rates were lower than 1.81% and within an acceptable range; The reference range of PT, APTT, TT and FIB were PT (9.1-13.1 s), APTT (24.9-42.1 s), TT (12.6-21.1 s), FIB (1.924-4.011 g/L). Conclusion The ACL TOP coagulation analyzer has good repeatability, stability, linearity and capability of anti-interference and anti-carryover.
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