人心肌脂肪酸结合蛋白胶体金快速检测试剂条的研制

Development of Colloidal Gold Rapid Test Strip for Human Heart Type Fatty Acid-binding Protein

建立一种以胶体金为基础的心肌脂肪酸结合蛋白质(H-FAB)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。最低检出限为10 ng·m L-1;10 min内即可观察结果;检测急性心肌梗塞(AMI)患者46例、正常人群85例,试纸条的敏感度为86.96%,特异度为97.65%,约登指数为0.8461,kappa值为0.8633,表明试纸条与临床确定的结果几乎一致。该方法方便、快捷,能有效的检测H-FAB,胶体金免疫层析试纸的研制为心肌梗塞的快速诊断与筛查奠定了基础。

To establish a rapid method of detecting human heart type fatty acid-binding protein（ H-FABP） of acute myocardial infarction（ AMI） patients,a rapid test strip of H-FABP was developed by using the gold-based immune chromatographic assay（ GICA） technology. Based on the principle of double-antibody sandwich method,the colloidal gold strip was developed. The specificity,sensitivity and clinical application were evaluated. Results showed that the lowest detection limit of assay was 10 ng · m L^-1and the detection time was about 10 min. The results of clinical detection of 46 patients with myocardial infarction（ AMI） and 85 normal people showed that the sensitivity and the specificity of the strip were 86. 96% and 97. 65%,respectively,Youden＇s index and Kappa value were 0. 8461 and0. 8633,respectively. There was no difference between the strip tests and clinical diagnosis results. This method was convenient,rapid and effective for the detection of H-FAB. The development of GICA was applicable and laid a solid foundation for the rapid determination and screening of AMI in clinics.