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人甲胎蛋白时间分辨免疫荧光分析试剂盒的研制
引用本文:杭建峰 吴英松 余伟鸿 徐伟文 王从容 裘宇容 李明. 人甲胎蛋白时间分辨免疫荧光分析试剂盒的研制[J]. 第一军医大学学报, 2005, 25(3): 313-317
作者姓名:杭建峰 吴英松 余伟鸿 徐伟文 王从容 裘宇容 李明
作者单位:[1]南方医科大学热带医学研究所,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]南方医科大学南方医院检验科,广东,广州,510515
摘    要:目的研制人甲胎蛋白(hAFP)时间分辨免疫荧光分析(TRFIA)试剂盒.方法采用双抗体夹心法建立AFP TRFIA 试剂盒,对试剂盒的各项指标进行评价.结果试剂盒的可测范围为l~1 000 U/ml,灵敏度为0.17 U/ml,精密度良好,批内和批间的精密度分别为3.3%~5.9%,3.7%~6.5%.与CEA、CA12-5、CA19-9、CA15-3、白蛋白无交叉反应.稳定性试验表明试剂可以在4℃稳定1年,37℃稳定7 d.426份正常血清标本测试该试剂盒的正常参考值范围是0~12 U/ml.用本试剂盒与国外同类试剂盒同时检测60份血清标本,其相关系数为0.995.结论试剂盒各项指标(灵敏度、精密度、特异性、稳定性、准确度)均达到临床检测要求,可替代国外同类产品试剂盒.

关 键 词:人甲胎蛋白(hAFP) 时间分辨免疫荧光分析(TRFIA) 试剂盒

Preparation of time-resolved fluoroimmunoassay kit for human alpha-fetoprotein detection]
Jian-Feng Hang,Ying-Song Wu,Wei-Hong Yu,Wei-Wen Xu,Cong-Rong Wang,Yu-Rong Qiu,Ming Li. Preparation of time-resolved fluoroimmunoassay kit for human alpha-fetoprotein detection][J]. Journal of First Military Medical University, 2005, 25(3): 313-317
Authors:Jian-Feng Hang  Ying-Song Wu  Wei-Hong Yu  Wei-Wen Xu  Cong-Rong Wang  Yu-Rong Qiu  Ming Li
Affiliation:Institute of Tropical Medicine, Southern Medical University, Guangzhou 510515, China. hangjianfeng_ren@163.com
Abstract:OBJECTIVE: To prepare time-resolved fluoroimmunoassay (TRFIA) kit for detecting human alpha-fetoprotein (hAFP). METHODS: Sandwich TRFIA kit for hAFP detection was developed using monoclonal antibody of anti-AFP. RESULTS: AFP-TRFIA kit was capable of detecting AFP within the range of 1-1 000 U/ml with sensitivity of 0.17 U/ml and without cross-reactivity with CEA, CA12-5, CA15-3, or CA19-9. The intra- and inter-assay coefficients of variation were (3.3-5.9)% and (3.7-6.5)%, respectively. The prepared AFP-TRFIA reagent could withstand preservation at 4 degrees celsius; for 1 year and at 37 degrees celsius; for 7 days with the cutoff value of 12 U/ml in healthy subjects (n=426). The correlation coefficient of the detection results between this kit and commercially available AFP kit (Wallac OY, Finland) for 60 blood samples was 0.995. CONCLUSION: The prepared TRFIA kit for hAFP detection meets the demand of clinical application with good sensitivity, precision, specificity, stability and accuracy.
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