D-二聚体胶体金免疫层析定量检测方法中包被浓度和标记浓度对其线性的影响

Study on the Linear of the Quantitative Detection Method of Colloidal Gold Immunochromatography for D-Dimer and the Establishment of Its Standard Curve

目的探索不同包被浓度和不同标记浓度对D-二聚体胶体金免疫层析定量检测方法线性的影响。方法采用尿激酶裂解纤维蛋白的方法制备D-二聚体标准品,用所制备D-二聚体试纸条对其在金标定量仪上进行检测以建立标准曲线;用此标准曲线对已用罗氏公司的D-二聚体检测试剂盒(免疫比浊法)定值过的血清进行检测,并对这两种结果进行相关性比较。结果①成功建立了D-二聚体胶体金免疫层析定量检测方法的标准曲线,线性范围为0.15625~10ug/mL,R^2为0.98297;与罗氏公司免疫比浊法检测方法的相关性良好,相关系数R^2为0.98486;②确定出D-二聚体胶体金免疫层析定量检测方法的最佳标记浓度和最佳包被浓度分别为1mg/mL 和1.5mg/mL。结论本研究成功建立了D-二聚体胶体金免疫层析定量检测方法的标准曲线,且确定出D-二聚体胶体金免疫层析定量检测方法的最佳的包被浓度和最佳的标记浓度。

Objective To establish the standard curve of the quantitative detection method of the colloidal gold immunochromatography for D-Dimer. Method Using the method of cracking fibrin by urokinase, we prepared the D-Dimer standards. They were tested on the colloidal gold quantitative instrument by using the D-Dimer test paper strips in order to establish the standard curve. And we used this standard curve to detect the level of D-Dimer in the serum,which has been determined out definite value by the D-Dimer test kit (immunoturbidimetry, ITM) of Roche. And the correlation of these two kinds of results was compared. Results ①We successfully established the standard curve of the quantitative detection method of the colloidal gold immunochromatography for D-Dimer. The linear range is 0.15625~10 ug/mL, and the R2 is 0.98297.And the correlation between the method we have established and the immunoturbidimetry of Roche is good, and the correlation coefficient R2 is 0.9849.②We determined out the best labeled concentration and the best package concentration of the quantitative detection method of the colloidal gold immunochromatography for D-Dimer,which are 1 mg/ml and 1.5 mg/ml respectively.Conclusion In this study,we successfully established the standard curve and successfully determined out the best labeled concentration and the best package concentration of the quantitative detection method of the colloidal gold immunochromatography for D-Dimer.