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时间分辨荧光免疫法定量检测CA125试剂盒临床应用研究
引用本文:梁志伟,;董志宁,;徐伟文,;李明,;吴英松. 时间分辨荧光免疫法定量检测CA125试剂盒临床应用研究[J]. 广东寄生虫学会年报, 2008, 0(11): 1119-1121
作者姓名:梁志伟,  董志宁,  徐伟文,  李明,  吴英松
作者单位:[1]南方医科大学,广州510515; [2]广州市达瑞抗体工程技术有限公司,广州510663; [3]南方医科大学生物技术学院,广州510515
摘    要:目的对自制CA125定量测定试剂盒(时间分辨荧光免疫法)进行临床应用研究,为该试剂盒的临床应用提供科学依据。方法按照自制试剂盒操作说明书对收集的410份血清进行测定,以电化学发光CA125定量测定试剂盒(Roche公司)为对照试剂,微粒子酶联免疫定量测定药盒(ABBOTT公司)为复核试剂,对测定的结果进行统计学分析。结果以电化学发光法为对照试验,其阳性符合率为98.35%,阴性符合率为98.81%,检验差异无统计学意义(P〉0.05);相关系数为0.937,相关性良好;ROC曲线下面积为0.998。结论本试剂盒检测性能能满足临床应用的需要。

关 键 词:癌抗原125(CA125)  时间分辨荧光免疫分析(TRFIA)  电化学发光免疫分析(ECLIA)

Clinic Application of Time-Resolved Fluoroimmunoassay (TRFIA) Based CA125 Quantitative Diagnostic Kit
Affiliation:LIANG Zhi-wei, DONG Zhi-ning, XU Wei-wen, LI Ming, WU Ying-song(1. 2004 Grade, Major of 8-Year-Clinic Medicine, School of the First Clinical Medicine, Southern Medical University, Guangzhou 510515; 2. Guangzhou Darui Antibody CO., LTD., Guangzhou 510663; 3. School of Biotechnology, Southern Medical University, Guangzhou 510515, China)
Abstract:Objective To evaluate the applicability of CA125 quantitative diagnostic kit. Methods The levels of CA125 from 410 blood samples were detected using the CA125-TRFIA. The results were compared with ECLIA. All the procedures were performed according to the quantitative diagnositic kit instruction manual. Results The positive accordant ratio was 98.35%, and the negative accordant ratio was 98.81%. In addition, the accordance coefficient was 0.937 and the AUCROC was 0.998. The result between the two tests was not significantly different (P〉 0.05). Conclusion Our results show that CA125-TRFIA is a valuable diagnostic kit for clinic application.
Keywords:CA125  TRFIA  ECLIA
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