RAPID INEXPENSIVE ASSAY FOR TB AND OTHER MYCOBACTERIA

MIDI将使用SMART软件结合超临界流体色谱(SFC)分析分枝杆菌的分枝杆菌酸，以诊断结核分枝杆菌感染。这种直接取痰化验只需不到三个小时，应该只是DNA技术成本的一小部分。由于结核病是全球主要的传染病死亡原因，这项技术应该在第三世界国家和美国得到应用。这项研究的创新方面包括使用配备荧光检测器的SFC(待开发的检测单元)，以及创建一种新的峰命名算法，用于SFC或高效液相色谱仪(HPLC)。该系统将完全自动化，将使用数据库的模式识别搜索，并将能够对霉菌酸含量低于最低或超标的样本进行自动重新分析，同时几乎不需要操作员干预。所有软件和分析技术也将同时设计为与高效液相仪器配合使用，以促进已在临床实验室中使用的此类设备。该系统的开发将获得美国食品和药物管理局(FDA)作为医疗器械的批准。潜在的商业应用：在美国，该系统的销售机会主要是在州卫生实验室和进行分枝杆菌鉴定的主要临床实验室。在第三世界国家，由于诊断的速度和成本非常低，世界卫生组织是一个潜在的买家。MIDI将销售软件和霉酚酸校准混合物，并与伯杰仪器公司合作销售硬件。

MIDI will use smart software coupled with supercritical fluid chromatography (SFC) analysis of the mycolic acids of mycobacteria for diagnosis of infection by Mycobacterium tuberculosis. This direct-from-sputum assay will take less than three hours and should be a small fraction of the cost of DNA techniques. As tuberculosis is the worldwide leading cause of death due to infectious disease, the technique should have application in third world countries as well as in the U.S. Innovative aspects of the research include using an SFC equipped with a fluorescence detector (the detector cell to be developed) along with the creation of a novel peak-naming algorithm for use with the SFC or high-performance liquid chromatograph (HPLC). The system will be fully automated, will use pattern recognition searches of the database and will be capable of automated re- analysis of samples with sub-minimal or excess mycolic acid content, while requiring little or no operator intervention. All software and analytical techniques will also be simultaneously designed to work with HPLC instruments to facilitate use of such devices already in clinical laboratories. The system will be developed so as to gain Food and Drug Administration approval as a medical device. POTENTIAL COMMERCIAL APPLICATIONS: In the United States, opportunities for sales of the system would primarily be in state health labs and in major clinical laboratories that perform identification of mycobacteria. In third-world countries, the World Health Organization is a potential purchaser due to the speed and very low cost of the diagnosis. MIDI would sell the software, the mycolic acid calibration mixture and cooperate with Berger Instruments in sale of the hardware.