E!8470 Veterinary point-of-care test device.

Immunoassay-based diagnostics, where specific protein concentrations can be measured by the binding between specific antibodies to its specific antigen, in veterinary medicine is complicated because antigens vary from species to species and immunoassay reagents used in human diagnostics cannot generally be used on other mammalian species. Immunoassays for human diagnostics are still used occasionally in veterinary laboratories, but without specific calibration and only arbitrary units reported. Immunoassays specific for animals are becoming available, but are run on modern high-priced clinical chemistry instruments. Some point-of-care (POC) immunoassays are available, but these POC devices are often not well suited to the rigors and time-constraints in the veterinary clinic. Compared to machine-dependent immunoassays, POC tests deliver fast results in a diagnostic setting where results and monitoring are time-critical. It is assumed that centralized services will continue to be used in non-critical testing. Through close cooperation, the project partners were able to successfully develop an immunoassay POC device for quick, time independent colometric detection of C-reactive protein in whole blood from canines. This acute phase protein can be used to differentiate between bacterial and viral infection in dogs and is already an important tool for veterinarians.

Background: Specific proteins are measured by immunoassay technology where a specific antibody binds to its specific antigen. Immunoassay-based diagnostics in veterinary medicine is complicated because antigens vary from species to species and immunoassa y reagents used in human diagnostics cannot generally be used on other mammalian species. State-of-the-art: Immunoassays for human diagnostics are used occasionally in veterinary laboratories, however without specific calibration and only arbitrary unit s are reported. Immunoassays specific for animals are becoming available. For example, Gentian Technology will supply a specific canine CRP and specific equine SAA in 2013. These immunoassays run on modern high-priced clinical chemistry instruments. Poi nt-of-care (POC) tests are available, for example, a canine CRP immunoassay from LifeAssays in 2009 measures inflammation in dogs. The available POC devices are often not well suited to the rigors and time-constraints in the veterinary clinic. However, P OC delivers fast results in a diagnostic setting where results and monitoring are time-critical. POC cannot compete with centralized laboratories on price or reliability and centralized services will continue to be used in non-critical testing. Challenge s: Raising veterinarian awareness of the benefits of modern immunoassay diagnostics requires a new approach that addresses the following requirements: 1. A robust and user-friendly POC device that works in the field and non-laboratory situations. 2. A ra pid, time-independent colorimetric method with reagents that give a test result within 2 minutes and where the color is stable for minimum 30 minutes. 3. A "killer application" - a specific canine CRP immunoassay POC offering fast and reliable quantitati ve results. 4. Evidence based research that documents the clinical value of immunoassay diagnostic methods for the patient, and demonstrates significant cost saving for both owner and veterinarian.