RAPID INEXPENSIVE ASSAY FOR TB AND OTHER MYCOBACTERIA

MIDI将使用智能软件结合超临界流体色谱（SFC）分析分枝杆菌的霉菌酸，用于诊断结核分枝杆菌感染。这种直接从痰液中提取的检测方法只需要不到三个小时的时间，而且只占DNA技术成本的一小部分。由于结核病是世界范围内因传染病导致死亡的主要原因，该技术应在第三世界国家和美国得到应用。该研究的创新方面包括使用配备荧光检测器（即将开发的检测器细胞）的SFC，以及创建用于SFC或高效液相色谱仪（HPLC）的新型峰命名算法。该系统将是完全自动化的，将使用数据库的模式识别搜索，并将能够自动重新分析含有微量或过量霉菌酸的样品，而很少或不需要操作员干预。所有软件和分析技术也将同时设计为与高效液相色谱仪器一起工作，以促进临床实验室中已经使用的这些设备。该系统将被开发以获得食品和药物管理局作为医疗设备的批准。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主要的临床实验室进行分枝杆菌鉴定。在第三世界国家，世界卫生组织是一个潜在的购买者，因为诊断速度快，费用很低。MIDI将销售软件和霉菌酸校准混合物，并与Berger Instruments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.