DEVELOPMENT OF IMPROVED SKIN TESTS FOR TUBERCULOSIS

在敏感性和特异性方面，确定的用于检测结核分枝杆菌的皮肤试验(Mtb)可能比PPD具有显著的优势。这种检测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接种。我们已经确定了在体外刺激人PBMC的新的结核分枝杆菌抗原，并在豚鼠结核病模型中引发了阳性的DH反应。这项建议的目的是评估这些抗原，以开发一种皮内试验，用于特异和敏感地检测结核分枝杆菌感染。拟议的商业应用：结核病皮肤测试的市场非常大，如果它将被用来取代PPD，市场将超过5000万美元。如果它用于一部分感染者，如艾滋病毒感染者，市场规模将会较小，但仍应超过每年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.