全自动血凝仪的性能评价及应用要求

Performance Evaluation of Automatic Coagulation Analyzer

目的:通过德国BE血凝仪BECompact-X在临床实验室中的应用,对其性能进行评价。方法:建立标准曲线,用标准血浆分别建立德国BE血凝仪检测项目的标准曲线。进行精密度、准确性、污染率检测。结果:精密度试验批内cv值为1.15%～2.03%,批间cv值为1.27%～5.60%,符合质控要求;准确性在仪器允许范围内;污染率为0～1.2%,可见仪器在每次测定后经自动冲洗,自洁系统好。结论:实验表明德国BE血凝仪BECompact-X的各项技术指标符合要求,精密度高,准确度好,不但能满足目前临床止凝血指标检测的需求,而且对设定新的止血和血栓检测指标也具有较大潜能。

Objective：to evaluate the performance of Germany BE automatic coagulation analyzer BECompaet-X through its application in clinical laborary. Method：Drawing up standard curve of Germany BE coagulation analyzer examination items by using standard human plasma. Precision, accuracy and contamination rate were checked.Result： precision test intra cv value is between 1.21%-2.10%, inter ev value is between 1.24%-5.18%, which is in accordance with quality control requirement; accuracy is within the permissable range; contamination rate is between 0-1.2%. It is apparent that the instrument has good auto clean system. Conclusion：It is proven that Germany BE coagu- lation analyzer BECompact-X is qualified in all technical performance with high precision and accuracy, which can not only satisfy the demands of current clinical examination, but also show great potential for setting new blood arrest- ing and blood clots measurements.