全自动血凝分析仪ACL TOP 700性能验证及评价

摘要

Objective To investigate the performance verification and clinical value of automatic blood coagu-lation analyzer ACL TOP 700 from IL Corporation of USA. Methods Taking prothrombin time (PTT), activated par-tial thromboplastin time (APTT), fibrinogen (FIBN), thrombin time (TT) as analysis parameters, the accuracy, precision, linearity, carrying contamination rate, interference experiments, accuracy and reference intervals observed for perfor-mance verification and evaluation of the instrument. Results The FIB accuracy bias of ACL TOP 700 was less than 10%, which was in line with the industry standard. The intra-assay precision and inter-batch precision were also in line with industry standards. The linear correlation coefficient of FIB was R=0.9991, a=0.9788, which was in line with the industry standard, and the the linear range was 0.45 g/L-10.06 g/L. The carrying contamination rate was in line with the industry standards and manufacturers nominal level requirements, with strong anti-interference ability to hemolysis, lip-ids, jaundice to ensure accuracy. The accuracy of the parameters was in line with the industry standard, and the reference range provided by the manufacturer was suitable. Conclusion The results of automatic blood coagulation analyzer ACL TOP700 is accurate and reliable, which can better meet the needs of clinical laboratory work.%目的 对美国IL公司的全自动血凝分析仪ACL TOP 700性能验证及其临床应用价值探讨.方法 以凝血酶原时间(PT)、活化部分凝血活酶时间(APTT)、纤维蛋白原(FIB)、凝血酶时间(TT)为分析参数,从正确度、精密度、线性、携带污染率、干扰实验、准确度及参考区间等方面对仪器进行性能验证及评价.结果 全自动血凝分析仪ACL TOP 700 FIB正确度偏倚小于10%,符合行业标准;批内精密度及批间精密度均符合行业标准要求;FIB线性相关系数R=0.9991、a=0.9788,符合行业标准,线性范围0.45~10.06 g/L;携带污染率符合行业标准及厂家标称水平要求;对溶血、脂血、黄疸的抗干扰能力强,保证结果准确;各参数的准确度均符合行业标准要求.厂家提供的参考区间适合.结论 全自动血凝分析仪ACL TOP700所测项目的结果准确可靠,能较好的满足临床实验室工作需求.