Tuberculosis (TB) is a significant public health threat worldwide. At this time there are no specific rapid screening tests available to assess the spread of this evolving pathogen. We propose to develop an effective serological screening method based on a combination of selected TB antigens and a specific antibody reaction. Four probable test configurations are described in this proposal. We will compare these four protocols and develop a """"""""one-step test"""""""" format similar to the one-step screening tests for pregnancy and drugs of abuse, designed and developed in this laboratory. The proposed test is based on the immunocomplexion of an immobilized reactant and sensitized microsphere dye particles. With selected TB antigens, including Antigen 60, as the anchor on the membrane, this test will be more sensitive and specific than any ELISA or RIA Serological tests for TB currently available. The colored precipitin can be easily visualized, and therefore negative and positive samples can be readily recognized. A predetermined cut-off concentration will allow the user to assess the total IgG plus IgM activity in the serum sample. Using a microbial culture procedure as reference, the proposed test will have a projected sensitivity greater than 85%, a specificity between 95-100% and a predictive value over 95%.
