DEVELOPMENT OF IMPROVED SKIN TESTS FOR TUBERCULOSIS

一种确定的皮肤试验，用于检测M。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从卡介苗免疫。我们已经确定了新的抗原Mtb刺激人PBMC在体外，并引发积极的DH反应，在豚鼠模型的结核病。本提案的目的是评价这些抗原，以开发用于特异性和敏感性检测M的皮内皮肤试验。肺结核感染。建议的商业应用：结核病皮肤测试的市场非常大，如果它被用来取代PPD，超过50，000，000美元。如果它用于感染者的子集，如艾滋病毒感染者，市场将较小，但每年仍应超过25，000，000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.