Current integrated modular systems for clinical diagnostics only operate after a large collection of sample material. Unfortunately, this increases the amount of time for patients to receive their test results or physicians to plan a course of treatment. Present day point-of-care-testing (POCT) immunoassay systems provide rapid results, but they are known for their poor accuracy and sensitivity, and often limited to qualitative or semi-quantitative assays. MSI has proposed to develop a portable, integrated, POCT system, by combining a self-contained, miniaturized chemiluminescence chip (CLCHIP) and microfluidic technologies that will dramatically improve POCT accuracy, sensitivity, and reliability. This innovative CLCHIP platform utilizes microfabrication technology to automate microfluidics for multi-analyte and multi-step biochemistries and reduce a complicated procedure to a single step. During Phase I of this project, we designed and fabricated microfluidic biochips with patterned microchannels, developed an on-chip chemiluminescence immunoassay protocol, performed a luteinizing hormone and troponin I bioassay, obtained linear dose-response curves, and achieved a total assay time of 15 minutes. Based on the foundation of Phase I we will move into Phase II, in order to optimize CLCHIP development, complete system integration, perform various analyte assays, multi-analyte panel testing, and achieve clinical performance requirements.
