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| 神经元特异性烯醇化酶(NSE)时间分辨荧光免疫分析试剂盒的临床性能评价 | |
| 引用本文： | 崔晓丙,王彪,张国兰,董志宁,徐伟文. 神经元特异性烯醇化酶(NSE)时间分辨荧光免疫分析试剂盒的临床性能评价[J]. 现代医学仪器与应用, 2008, 20(1): 4-7 |
| 作者姓名： | 崔晓丙 王彪 张国兰 董志宁 徐伟文 |
| 作者单位： | 1. 南方医科大学,广东,广州,510515 2. 广州市达瑞抗体工程技术有限公司,广东,广州,510663 3. 南方医科大学生物技术学院,广东,广州,510515 |
| 基金项目： | 广东省广州市创新条件建设项目 , 国家高技术研究发展计划(863计划) |
| 摘 要： | 目的对自制的神经元特异性烯醇化酶时间分辨荧光免疫分析试剂盒进行临床应用研究及临床性能评价。方法用自制试剂盒检测采集到的血清1008例,Roche公司电化学发光试剂盒作为对照试验,WALLAC公司时间分辨荧光免疫分析试剂盒作为复核试验。操作按各试剂盒说明书进行,对自制试剂盒的符合率和相关性等指标进行计算分析。结果同Roche电化学发光试剂盒比较,自制试剂盒阳性符合率为98.04%,阴性符合率为98.39%;两者测定值接近,相关系数为0.973,相关性好,P=0.000。其AUCROC值为0.994。结论本试剂盒检测性能满足临床应用的需要。 |
| 关 键 词： | 神经元特异性烯醇化酶(NSE) 时间分辨荧光免疫分析(TRFIA) 体外诊断(IVD) |
The Clinic Study of the Neuron Specific Enolase(NSE)Diagnostic Kit by Time-Resolved Fluoroimmunoassay(TRFIA) |
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| CUI Xiaobing,WANG Biao,ZHANG Guolan,DONG Zhining,XU Weiwen. The Clinic Study of the Neuron Specific Enolase(NSE)Diagnostic Kit by Time-Resolved Fluoroimmunoassay(TRFIA)[J]. , 2008, 20(1): 4-7 | |
| Authors: | CUI Xiaobing WANG Biao ZHANG Guolan DONG Zhining XU Weiwen |
| Abstract: | Objective To investigate the value of the new kit (NSE-TRFIA) for detection of NSE by the time—resolved fluoroimmunoassay (TRFIA). Methods Compared with the techniques of ECLIA, measuring the level of NSE from the 1008 blood samples with the NSE-TRFIA. Verified by WALLCTM NSE-TRFIA. Results The positive accordant ratio was 98.04%, the negative accordant ratio was 98.39%. The accordance of new kit with ECLIA was good as the accordance coefficient was 0.973. The AUCROC of NSE-TRFIA was 0.994. Conclusion NSE-TRFIA was a valuable diagnostic kit for clinic application. |
| Keywords: | NSE TRFIA IVD |
| 本文献已被 CNKI 维普 万方数据 等数据库收录！ | |