Luminex, an ISO certified and FDA compliant company with cGMP manufacturing, will develop and deliver a robust multiplex assay system to quickly determine clinically relevant infections. This proposal focuses on the rapid determination of the etiological agent(s) involved in respiratory infections. This system, built on Luminex proprietary xMAP technology, will have the capacity to simultaneously detect up to 50 different antigens in a single reaction. A fully automated front end sample preparation unit will deliver samples to a rugged, battery operated Luminex analyzer. The analyzer instrument will be a small, rugged LED-based instrument (BeadPix) with a small Bill of Materials (~$10K) and a small instrument footprint for easy deployment to first responders or other non-traditional health care settings. The diagnostic instrument proposed will have a fully integrated and highly automated front-end that will allow a minimally trained user to insert a sample (cartridge) and receive an answer. To this end, Luminex will design the sample preparation architecture. This will consist of development of an assay preparation cartridge and accompanying fluidics. The assay preparation cartridge will process a clinical sample, extracting the nucleic acid and protein components, and completing the xMAP-based assay. The assay will be automatically fed into a ruggedized BeadPix analyzer, resulting in a rapid answer from a small clinical sample. Our goal is for the front-end to satisfy the requirements of a CLIA waiver, meaning it will simply involve a medical professional placing a sample into the instrument, pressing a single """"""""start button,"""""""" followed by the instrument providing a final, useable result requiring no further analysis (e.g. a point-of-care application).
