The development and validation of a tick-borne disease panel test is proposed. This rapid, recombinant antigen-based membrane immunoassay will simultaneously detect antibodies to the agents of Lyme disease, Human Granulocytic Ehrlichiosis, Human Monocytic Ehrlichiosis, Babesiosis, and Rocky Mountain Spotted Fever. Early and accurate diagnosis of these emerging tick-borne diseases is critical to successful therapy, but presently, no commercial tests are available in kit form. Likewise, no single test is currently available to diagnose coinfections with more than one of these pathogens, which may alter therapy and have assumed increasing clinical importance in recent years. The proposed test is the first of its kind based on a proprietary flow-through technology which accelerates the turnaround time to 15 minutes in place of the hours required by conventional immunoassays. Multiple samples can be tested simultaneously in a simple procedure carried out on lmmunetics' CodaXcel(TM) instrument, developed in Phase I. In Phase II, development of the tick-borne panel will be completed and the test will be validated in retrospective and prospective studies of patient sera at Immunetics and four collaborating clinical centers. The test will also be validated on CodaVision(TM), lmmunetics' fully automated membrane immunoassay instrument.
The proposed tick-borne disease test will be the first commercial kit available to clinical laboratories for serodiagnosis of HGE, HME, Babesia, RMSF and Lyme disease. The speed and simplicity of the test will establish a new industry standard and open the expanding market for tick- borne testing to the average, non-specialty clinical laboratory.