This Small Business Innovation Research (SBIR) Phase II project proposes to develop a new signal amplification system that, while being inexpensive and simple to use, can be combined with antibodies or other probe molecules and can increase detection limits of conventional Enzyme-linked immunosorbent assay (ELISA) by 100 to 1000-fold. ELISA has been used both in science and diagnostic for more than 40 years. ELISA is simple, reliable, and inexpensive technique. However, because of the nature of enzymes used in this technique as signal-generating and amplifying device, it has a relatively low sensitivity. During Phase I, it was demonstrated that substitution of these enzymes with phages that can propagate and simultaneously generate light signal substantially increases the sensitivity of ELISA and simultaneously reduces cost of the assay without complicating its protocol. In Phase II, the goal is to further improve sensitivity and response time of the system and create two types of products: 1) components that can be plugged-in into conventional ELISA system, and 2) kits designed for detection of specific toxins and other pathogens.
The broader impact /commercial potential of this project is expected to impact the areas of basic research, biodefense, and medicine. The proposed system will allow very sensitive and inexpensive detection of antigens of choice. For those involved in basic research, the proposed immunoassay will allow a significantly more detailed analysis of biological processes, possibly even opening the doors to monitoring those processes and molecules previously undetectable. In biodefense and medical diagnostics, increased sensitivity will mean an increased security by allowing earlier detection of harmful pathogens, as well as pathological changes in the human organism.
