摘要
目的：评价ACLTOP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ACLTOP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ACLTOP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（AfrIT）、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20mg／dL、甘油三脂900mg／dL、血红蛋白5g／L时，对胛、APTT、TT和FIB测定的影响度均小于二分之一CLLA’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—13．1S）、APTT（24．9～42．1s）、TT（12．6～21．1s）、FIB（1．924～4．011g／L）。结论：ACLTOP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 （AFFT）, Thrombin Time （TlP）, 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, AFFF 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 ; Tile 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, AFFF, TT and FIB were PT （9.1-13.1 s）, AFFF （24.9-42.1 s）, TF （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.
出处
《实用医学杂志》
CAS
北大核心
2014年第6期965-969,共5页
The Journal of Practical Medicine
基金
深圳市儿童重症疾病诊断重点实验室课题(编号:深发改[2012]886号)
关键词
血凝仪
生物参考区间
儿科
Coagulation analyzer system
Reference interval
Paediatries
