Establishment and clinical evaluation of dry fluorescent luminescencemethod for detection of antibodies to hepatitis C virus

Abstract

Objective To establish a dry fluorescent luminescence method for the detection of antibodies to hepatitis C virus (HCV) and evaluate its clinical application. Methods Anti-HCV antibody was detected by double-antigen sandwich dry fluorescent luminescence method established using multi-epitope chimeric antigen. The established method was used to detect national reference samples(positive 20, negative 20), and a total of 349 clinical samples, including 108 HCV patients, 36 patients with other diseases and 205 healthy individuals, which were tested in parallel with enzyme-linked immunoassay (ELISA) to evaluate the performance of the established method. Results The concordance rate of positive and negative(each 20) reference samples were both 100% (20/20), and the CV of precision reference sample was 9.16%, which met the requirements of national reference samples. In clinical performance evaluation, the AUC value was 0.984, and the sensitivity and specificity of the dry fluorescent luminescence method were 96.30% (104/108) and 96.27% (233/241). The overall concordance rate between dry fluorescent luminescence method and ELISA was 97.71% (341/349) (Kappa=0.952). Conclusion The dry fluorescence luminescence method of HCV antibody is simple and rapid, with high sensitivity and high specificity, and can be used in clinical application.

Keywords

• hepatitis c virus antibody detection
• dry fluorescent luminescence method
• dominant epitope chimeric hcv antigen
• technical performance evaluation