Abstract: Objective To establish a dry fluorescent luminescence technique for the joint detection of HBsAg, HCV-Ab, TP-Ab and HIV-Ab, and to evaluate its clinical application. Methods Based on immunochromatography and fluorescence luminescence technique, HBsAg, anti-HCV, anti-HIV and anti-TP were detected with double sandwich method. National reference materials were adopted, and clinical samples were tested in parallel with enzyme linked immunosorbent assay(ELISA)to evaluate the performance of the dry fluorescent luminescence technique. Results The detection results of HBsAg, HCV-Ab, TP-Ab and HIV-Ab reference samples met the requirements of national reference standards. In clinical performance evaluation, the detection sensitivities of HBsAg, HCV-Ab, TP-Ab and HIV-Ab were all higher than 95%; the detection specificities of HBsAg, TP-Ab and HIV-Ab were higher than 95%, and the detection specificity of HCV-Ab was 91%. The AUC of the ROC curves were all close to 1. Compared with the ELISA, this technique had total coincidence rates of HBsAg, HCV-Ab, TP-Ab and HIV-Ab all above 94%, and their Kappa values ranged from 0.9 to 1.0. Conclusion The dry fluorescent luminescence technique for the joint detection of HBsAg, HCV-Ab, TP-Ab and HIV-Ab can produce results which are highly consistent with those of ELISA. It is a rapid and simple point-of-care testing method with high sensitivity and specificity, and can meet the needs of clinical detection.

Key words: Dry fluorescent luminescence, HBsAg, HCV-Ab, TP-Ab, HIV-Ab, Clinical evaluation