The establishment of detecting cytokerantin 19 fragment(CYFRA21-1) with immunofluorescence chromatography

Abstract

This study was designed to develop a immunofluorescence chromatography kit for detection of CYFRA21-1 in human serum, and to evaluate the method performance. The fluorescent polystyrene particle conjugated with the monoclonal antibody MIC07 was used as a fluorescent label. The monoclonal antibody MIC08 and mouse anti-rabbit IgG were immobilized on the nitrocellulose membrane as the test line and control line. The linear response rang of the method to detect the serum CYFRA21-1 was 0.29–500ng/ml. And the intra-and inter-assay coefficient were 3.64% and 6.53%. Total 1200 samples were tested by the immunofluorescence chromatography kit, and the overall coincidence rate was 95.69%. The positive coincidence rate was 96.41%, the negative coincidence rate was 93.89%, and the Kappa value surpassed 0.8, which indicated that there was no significant difference between the results of the immunofluorescence chromatography kit and Elisa kit. In conclusion, the immunofluorescence chromatography kit for assaying CYFRA21-1 provided high sensitivity, rapid, simple operation, low cost, single-servings and can be extensively used for clinical operarions.