摘要
目的研制CA125时间分辨荧光免疫分析(TRFIA)试剂盒。方法采用双抗体夹心法建立CA125TRFIA试剂盒,对试剂盒各项指标进行评价。结果该试剂盒的工作范围为10～600U/m l,分析灵敏度为1.07U/m l,批内、批间的精密度分别为4.5%～8.1%,6.9%～11.5%。与CEA、AFP、CA50、CA15-3、CA19-9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7d。425份正常血清标本测试该试剂盒的正常参考值范围是0～37U/m l。123份血清标本用本试剂盒与国外其他方法的同类试剂盒同时检测,其相关系数为0.939。结论试剂盒各项指标均达到临床检测要求,可替代国外同类产品试剂盒。
Objective To prepare a kit for the detection of CA125 in serum by time-resolved fluoroimmunoassay（TRFIA）. Method Two anti-CA125 monoelonal antibodies were used to develop the sandwich TRFIA kit for detection of CA125 in serum. Results The working range of kit was 10-600U/ml. The analytical sensitivity was 1.07U/ml. There was no cress-reactivity with CEA,AFP, CA50, CA15-3 and CA19-9. The intra-assay and inter-assay coefficients of variation were 4.5%～8.1% and 6.9%～11.5%, respectively. The TRFIA CA125 reagents can be stored at 4℃ for 1 year and at 37℃ for 7 days. The cutoff value for TRFIA CA125 kit in healthy subjects （n=425） was 37U/ml. The correlation coefficient of blood samples detection results （n= 123 ） between home-made and commercially available CLIA CA125 kit （Roche） was 0.939. Conclusion CA125 TRFIA kit was a valuable diagnostic kit for clinical application with better sensitivity, specificity, and accuracy.
出处
《热带医学杂志》
CAS
2005年第5期567-570,582,共5页
Journal of Tropical Medicine
基金
广州市研究开发基地建设项目(No.2003U130021)。
