IMMUNODIAGNOSTIC TESTS FOR THE RAPID DIAGNOSIS OF TB

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Tuberculosis (TB) is a global leading public health problem and the leading cause of death in people with AIDS. There is an urgent need for early and accurate diagnosis of pulmonary TB (PTB) to achieve the goal of elimination of TB in the United States, improve TB control worldwide, and identify and treat active TB before development of advanced disease. Currently, no rapid tests with high sensitivity and specificity are available for all classes of TB. The investigators propose to examine the accuracy and clinical value of antibody detection to two immunodominant proteins of M. tb for the rapid diagnosis of PTB. The central hypothesis is that a serodiagnostic test, in the form of two protein-based ELISAs combined, is accurate and clinically useful. Alone and in combination with a rapid T-cell-based assay, it can serve as an adjunct to current conventional rapid tests for PTB. The specific aims of this project are as follows: 1) to assess sensitivity, specificity and clinical value of the ELISAs; 2) to determine serum antibody titers to the two recombinant proteins pre, at and post antituberculosis treatment of TB patients; and 3) to test if other available recombinant proteins of M. tb will enhance the sensitivity of the ELISAs without compromising specificity. This will be a prospective, observational study in a United States population. Consecutive patients undergoing clinical evaluation for PTB will be enrolled from two large hospitals in New York City (Bellevue Hospital Center and the Manhattan VA Medical Center). Results of the ELISAs and other tests will be compared to the gold standard of culture of histological or clinically proven PTB.