Development and preliminary application of colloidal gold-based immunochromatographic test strips with colloidal gold for rapid detection of NJ001 specific antigen

Abstract

Objective To develop a colloidal gold immunochromatographic assay for rapid detection of NJ001 specific antigen. Methods Polyclonal antibody was prepared by immunizing New Zealand rabbit with SPC-Al cells.Polyclonal antibody and Goat anti mouse IgG,as test line and control line respectively，were immobilized on nitrocellulose membrane,NJ001 was labeled by colloidal gold particles and then sprayed and fixed on fiberglass membrane as the combination pad.Together with a specimen pad ahead．The nitrocellulose membrane and the conbination pad were assembled into a test strip.The poisitive rate of NJ001 were examined from 52 lung adenocarcinoma patients and 40 healthy controls(HC).In the lung adenocarcinoma group, 49 were comfirmed by TNM, 15 stageⅠ/Ⅱ 34 stageⅢ/Ⅳ,and 3 cases without TNM staging data. 45 patients had lymphatic metastasis data,22 cases were of no lymphatic metastasis and 23 cases were of lymphatic metastasis.There were another 7 cases without the data of lymphatic metastasis. Results Positive rate of NJ001 in lung adenocarcinoma patients was 55.77%,significantly higher than that of HC(7.5%)（χ2=23.22，P＜0.001）.Positive rate of NJ001 specific antigen in patients at TNM stage Ⅲ/Ⅳ was higher than that at TNM stageⅠ/Ⅱ（64.17% vs 33.33%，χ2=4.141，P=0.042）; Positive rate in patients with lymph nodes metastasis was higher than that in patients without lymph nodes metastasis（69.57% vs 36.36%，χ2=4.98，P=0.026）. Conclusion This study successfully establishes a colloidal gold immunochromatographic assay that can be used to rapid detect NJ001 specific antigen in clinical serum samples.（Chin J Lab Med,2014,37:548-552） Key words: Lung neoplasms; Adenocarcinoma; Antibodies, monoclonal; Gold colloid; Immunochromatography