[用于人甲胎蛋白检测的时间分辨荧光免疫分析试剂盒的制备]

[Preparation of time-resolved fluoroimmunoassay kit for human alpha-fetoprotein detection].

作者信息

Hang Jian-Feng, Wu Ying-Song, Yu Wei-Hong, Xu Wei-Wen, Wang Cong-Rong, Qiu Yu-Rong, Li Ming

机构信息

Institute of Tropical Medicine, Southern Medical University, Guangzhou 510515, China.

出版信息

Di Yi Jun Yi Da Xue Xue Bao. 2005 Mar;25(3):313-7.

PMID:15772001

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.

摘要

目的

制备用于检测人甲胎蛋白（hAFP）的时间分辨荧光免疫分析（TRFIA）试剂盒。

方法

采用抗AFP单克隆抗体研制夹心型hAFP检测TRFIA试剂盒。

结果

AFP-TRFIA试剂盒能够在1-1000 U/ml范围内检测AFP，灵敏度为0.17 U/ml，与癌胚抗原（CEA）、糖类抗原125（CA12-5）、糖类抗原153（CA15-3）或糖类抗原199（CA19-9）无交叉反应。批内和批间变异系数分别为（3.3-5.9）%和（3.7-6.5）%。制备的AFP-TRFIA试剂在4℃可保存1年，在37℃可保存7天，健康受试者（n=426）的临界值为12 U/ml。60份血样该试剂盒与市售AFP试剂盒（芬兰Wallac OY公司）检测结果的相关系数为0.995。