This research team has recently demonstrated integrated optofluidic enzyme-linked immunosorbent assay (ELISA) technology that can tremendously improve the ELISA performance. The proposed project will be focused on the effort to further develop the optofluidic ELISA technology. The integrated optofluidic device is a plastic module that consists of 96 flow-through multi-hole capillaries, which improves the analyte capture efficiency/rate and the signal-to-noise ratio. Currently, it is capable of detecting 1 pg/mL of analytes in only 55 minutes by using only 5 micro-liter sample/reagents, which is already 4-fold, 8-fold, and 20-fold improvement in detection limit, detection time, and sample/reagent consumption, respectively, over the traditional ELISA. Additional 10-fold improvement in sensitivity and analysis speed is expected as the development efforts continue. Significantly, the optofluidic ELISA device is fully compatible with the existing ELISA readers without the need of modification.
The proposed device has the potential to be faster, more sensitive, and more cost-effective. Therefore, it could replace the current devices in use. The proposed ELISA device has a societal impact when used in biomedicine. Due to its rapid analysis, it can be used in emergency rooms to provide time-critical information to save lives. The high sensitivity enables early-diagnosis, disease prognosis, and therapeutically monitoring of patients. Finally, significant reduction in reagent volumes translates directly to over 75% savings in healthcare costs. The device is also beneficial to industries and research labs. It expedites the testing turn-around time, cuts the research and development costs, and helps identify molecules at extremely concentrations.
Enzyme-linked immunosorbent assay (ELISA) is a powerful method for detecting and quantifying specific analytes in complex liquid mixtures. It is widely used in hospitals and industrial/research labs. However, the traditional ELISA suffers from a few major drawbacks: (1) long testing time (3-6 hours), which makes the ELISA almost useless when dealing with emergency care where the results should be obtained as quickly as possible; (2) large sample and reagent consumption (50-100 uL per sensor well), which adds significant costs to customers; and (3) inadequate detection limit, typically on the order of 10-100 pg/mL, which makes it impossible to measure many clinically significant biomarkers at low concentrations. Intellectual Merits The integrated optofluidic device is a plastic module that consists of 96 flow-through multi-hole capillaries, which significantly improves the analyte capture efficiency/rate and the signal-to-noise ratio. Currently, it is capable of detecting 1 pg/mL of analytes in only 30 minutes by using only 5 uL sample/reagents, which is already 4-fold, 8-fold, and 20-fold improvement in detection limit, detection time, and sample/reagent consumption, respectively, over the traditional ELISA. Additional 10-fold improvement in sensitivity and analysis speed is expected as the development efforts continue. Significantly, the optofluidic ELISA device is fully compatible with the existing ELISA readers without the need of modification. Broader Impacts The proposed device will be faster, more sensitive, and more cost-effective. Therefore, it is expected to replace the current ELISA device in the marketplace. The proposed ELISA device has a tremendous societal impact when used in biomedicine. Due to its rapid analysis, it can be used in emergency rooms to provide time-critical information to save lives. The high sensitivity enables early-diagnosis, disease prognosis, and therapeutically monitoring of patients. Finally, significant reduction in reagent volumes translates directly to over 75% savings in healthcare costs. The device is also beneficial to industries and research labs. It expedites the testing turn-around time, cuts the research and development costs, and helps identify molecules at extremely concentrations. Major activities and findings In the 6-month project, we attended two workshops hosted by the NSF I-Corps program and one trade show, and trained the entrepreneurial leader in how to commercialize a product. In addition, we interviewed approximately 100 customers, potential partners, and supply chains, and completed a business plan. Meanwhile, we completed the prototype of the proposed optofluidic ELISA plates and tested them using a standard ELISA reader. We found that our ELISA plates were highly compatible with the reader. Using our plates, ELISA could be completed within 30 minutes (excluding pre-coating procedure), which we believe can be further shortened. The detection limit is about 1 pg/mL. Based on our results, we filed a patent disclosure, formed a start-up company, and contacted a few potential investors.
