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.
