内科

目的对艾瑞德快速免疫分析仪检测C反应蛋白的性能进行验证和评价。方法根据美国临床和实验室标准化协会（CLSI）标准，结合工作实际，对艾瑞德快速免疫分析仪检测C反应蛋白的检出限、精密度、准确度、线性范围等主要性能进行验证和评价，并将实验结果与贝克曼AU5821自动生化分析仪、特定蛋白仪检测C反应蛋白各项检验性能进行比较。结果艾瑞德快速免疫分析仪检测C反应蛋白的检出限、批内及批间精密度、准确度均在厂商声明范围内，并具有较好的线性范围，符合临床应用要求。贝克曼AU5821自动生化分析仪及特定蛋白仪检测C反应蛋白的批内、批间精密度亦均在厂商声明范围内。艾瑞德快速免疫分析仪、贝克曼AU5821自动生化分析仪与特定蛋白仪检测全血、血清样本C反应蛋白结果差异无统计学意义（P＞0.05）。艾瑞德快速免疫分析仪所需检验时间较贝克曼AU5821自动生化分析仪、特定蛋白仪短（P＜0.05）。结论艾瑞德快速免疫分析仪可用于临床即时检测C反应蛋白。

ObjectiveTo verify and evaluate the performance of Everyday Rapid Immune Analyzer for detecting C reactive protein. MehtodsAccording to the standar of American Clinical and Laboratory Standards Institute (CLSI), and combining with clinical practice, the main performance of Everyday Rapid Immune Analyzer for detecting C reactive protein was verified and evaluated, including dectection limit, precision, accuracy and linearity,and the results were compared with the various performance of Backman AU5821 automatic bilchemical analyzer and special protein instrument for C reactive protein. ResultsThe detection limit,intra-batch and inter-batch precision, accuracy of Everyday Rapid Immune Analyzer for C reactive protein were in the range of manufacturer statement,and had a good linear range, accorded with the reqirement of clinical application.The intra-batch and inter-batch precision of Backman AU5821 automatic biochemical analyzer and special protein instrument detection for C reactive protein were also in the range of manufacturer statement.There was no significant statistical difference in the test results of C reactive protein concentration from blood or serum among Everyday Rapid Immune Analyzer, Backman AU5821 automatic biochemical analyzer and special protein instrument (P＞0.05). The detection time of C reactive protein by Everyday Rapid Immune Analyzer was significantly shorter than that by Backman AU5821 automatic biochemical analyzer and special protein instrument (P＜0.05). ConclusionsEveryday Rapid Immune Analyzer can be used for clinical point-of-care testing of C reactive protein.