A族链球菌胶体金免疫层析试纸条的制备及应用

Development and application of colloidal gold immunochromatographic test strip for group A Streptococcus

目的建立一种以胶体金为基础的A族链球菌(Strep-A)免疫层析快速检测方法。方法以双抗体夹心的原理研制胶体金免疫层析试纸条,并对其特异性、灵敏度以及临床应用进行评价。结果最低检出浓度为105CFU/m L;10 min内即可观察结果;与B族链球菌、D族链球菌、金黄色葡萄球菌均无交叉反应;检测229例临床样本,以传统的细菌培养鉴定结果为对照,敏感度为97.30%,特异度为98.06%,kappa值为0.950,一致性检测表明两者无显著性差异。结论该方法方便、快捷,能有效的辅助诊断A族链球菌感染,胶体金免疫层析试纸的研制为Strep-A进行现场快速诊断与筛查奠定了基础。

Objective To establish a rapid method for detection of Group A Streptococcus(Strep-A),colloidal gold-based immune chromatographic assay(GICA) was used.Methods Based on the principle of double-antibody sandwich method,the colloidal gold strip has been developed.The specificity,sensitivity and clinical application were evaluated.Results The lowest detection limit of assay was 105CFU/m L and the detection time is about 10 min.The cross-reactions showed that there is no cross-reaction between test strip and group B Streptococcus,group D Streptococcus and staphylococcus aureus.In the 229 cases of clinical samples,the sensitivity and the specificity were 97.30% and 98.06% respectively.Kappa was 0.950 and consistency test showed no significant difference between results of traditional bacterial culture identification and test strip.Conclusions This method was convenient,rapid and effective for the detection of pathogenic Group A Streptococcus(StrepA).The development of GICA was applicable and laid a solid foundation for the rapid determination and screening of Strep-A in the field.