Diagnosis of tuberculosis in an Indian population by an indirect ELISA protocol based on detection of Antigen 85 complex: a prospective cohort study

摘要: Diagnosis of tuberculosis (TB) remains problematic despite many new advanced diagnostic methods. A reliable and rapid test, which could be performed in any standard pathology laboratory, would help to obtain definitive early diagnoses TB. In the present study we describe a prospective evaluation for demonstrating Antigen (Ag) 85 complex sera from TB patients. Indirect ELISA, employing monoclonal antibodies (mAb) against purified Ag complex, was used demonstrate Serum samples were obtained 197 different groups patients: confirmed {n = 24}, clinically diagnosed 104}, disease controls 49} healthy 20}. Receiver operating curve (ROC) calculate cut off value comparison between non-TB done by chi-square test. The indirect ELISA method, using an mAb yielded 82% sensitivity (95% confidence interval [CI] 67 93%) 86% specificity CI, 57 98%) diagnosis serum positivities cases patients 96% (23/24) 79% (82/104) respectively, while positivity non-tuberculosis group 14% (10/69). detection gives can develop immunodiagnostic assay with increased specificity.