DEVELOPMENT OF IMPROVED SKIN TESTS FOR TUBERCULOSIS

明确的皮肤试验检测结核分枝杆菌（Mtb）在敏感性和特异性方面可能比PPD具有显著优势。这种测试可用于艾滋病毒感染者，并可用于区分结核分枝杆菌和卡介苗免疫。我们已经鉴定出新的Mtb抗原，在体外刺激人PBMC，并在豚鼠结核病模型中引起阳性DH反应。本提案的目的是评估这些抗原，以开发一种皮内皮肤试验，用于特异性和敏感地检测结核分枝杆菌感染。拟议的商业应用：结核病皮肤试验的市场非常大，如果用于替代PPD，将超过5000万美元。如果它用于受感染个体的子集，如艾滋病毒感染者，市场将较小，但每年仍应超过2500万美元。

A defined skin test for detecting M. tuberculosis (Mtb) could have significant advantages over PPD in terms of sensitivity and specificity. Such a test could be used in persons infected with HIV, and could be used to distinguish Mtb from BCG immunization. We have identified new antigens of Mtb that stimulate human PBMC in vitro, and that elicit positive DH responses in the guinea pig model of tuberculosis. The goal of this proposal is to evaluate these antigens for the development of an intradermal skin test for the specific and sensitive detection of M. tuberculosis infections. PROPOSED COMMERCIAL APPLICATIONS: The market for a tuberculosis skin test is very large, exceeding $50,000,000 if it would be used to replace PPD. If it is used in a subset of infected individuals, such as HIV infected, the market would be smaller, but should still exceed $25,000,000 per year.