NOVEL ANTIGENS FOR USE IN SERODIAGNOSIS OF TUBERCULOSIS

目前的建议是制定标准化测试， 使用血清学方法确认活动性结核病患者， 与已经鉴定的新型重组抗原的组合， 可以诊断为结核病 这种疾病是一个世界性的问题， 是发展中国家的主要死因之一 是 据估计，在195年，19亿人是携带者， 890万新病例发展为活动性疾病。 1995年 3.1百万人死于这种疾病。 需要测试能够 因此，区分活动性疾病和非活动性疾病很重要。 拟议的研究将有助于制定标准化测试 （ELISA和免疫印迹）使用新的重组抗原， 显示PPD+个体与活动性TB患者的区别。 的 拟议的研究将导致廉价，可靠的测试， 一个大市场。 这种测试的发展将利用Corixa的 与发展中国家的调查人员建立了合作， 提供了一个庞大的血清库 这将用于 评估所开发测试的临床灵敏度和特异性。 拟议的商业应用：在肺结核和肺结核患者中检测活动性结核， 美国和全世界都可以节省大量的医疗费用。 在 就市场潜力而言， 按每次测试1美元计算，将超过1亿美元。

The present proposal is to develop standardized tests for detecting and confirming active Tuberculosis in patients using serological methods in combination with novel recombinant antigens that have been identified and shown to be diagnostic for TB. The disease is a worldwide problem and is one of the leading causes of death in the developing world. It is estimated that in 195, 1.9 billion individuals were carriers of the disease and that 8.9 million new cases developed active disease. In 1995 3.1 million died from the disease. The need for tests to be able to differentiate between active and inactive disease is therefore important. The proposed studies will enable the development of standardized tests (ELISA and immunoblot) using novel recombinant antigens that have been shown to differentiate PPD+ individuals from active TB patients. The proposed studies will lead to inexpensive, reliable tests that will serve a large market. The development of such tests will capitalize on Corixa's established collaboration with investigators in developing countries which has provided access to an extensive serum bank. This will be used in assessing the clinical sensitivity and specificity of the tests developed. PROPOSED COMMERCIAL APPLICATION: The detection of active TB both in the U.S and the world can lead to significant savings in health costs. In terms of market potential the estimated worldwide sales of such tests would be in excess of $100 million, based on a cost of $1 per test.