Project: New immunoassay technology for acute phase proteins for all mammals

Background: _x000D__x000D_Most methods for measuring clinical chemistry parameters are interchangeable in human and veterinary medicine. Small molecules such as hormones, carbohydrates and electrolytes have similar functions in all mammals. Enzyme activity is generally determined by measuring small molecular substrates or substances that are converted by enzymes. _x000D__x000D_The situation for measuring specific proteins is quite different. Specific proteins are measured by immunoassay technology where a specific antibody binds to its specific antigen. Over the last 40 years the development of immunoassay diagnostics has revolutionized human medicine. Immunoassay-based diagnostics in veterinary medicine has not had the same progression because antigens vary from species to species and immunoassay reagents used in human diagnostics cannot generally be used on other mammalian species. _x000D__x000D__x000D_State-of-the-art:_x000D__x000D_The veterinary market is not well supplied with immunoassays. Immunoassays for human diagnostics are used occasionally in veterinary laboratories, however without specific calibration and only arbitrary units are reported. A few specialised products are available, for example, a CRP immunoassay from LifeAssays in 2009 diagnoses inflammation in dogs. The assay is dog specific and will not work on other mammalian species._x000D__x000D_While a wide range of standard clinical chemistry diagnostic tests are available for in-house diagnostic use in veterinary clinics, only a very few immunological parameters can be measured directly by the veterinarian in-house. Lateral flow immunoassays, which are easy to handle and deliver fast results, provide t only qualitative results. To make more immunological parameters available for veterinary in-house diagnostics an easy to use and flexible method has to be developed which provides the vet with fast and reliable quantitative results. _x000D__x000D_Veterinary practices do not have the finances and trained technicians required to COtain modern clinical chemistry machines that are expensive, complicated and have high test capacity. _x000D__x000D__x000D_Three obstacles must be overcome so that veterinary immunoassay diagnostics become a reality: _x000D__x000D_1. Immunoassays must be general so that one immunoassay serves all mammalian species _x000D_2. Immunoassays must run on a simple-to-use, fool-proof, low-COtenance clinical chemistry platform requiring minimal operator training_x000D_3. Immunoassays must be of robust design, homogeneous, non-separation-based and delivered in volumes that match the usage requirements of the modern veterinary practice. _x000D__x000D_General Goals:_x000D__x000D_1. Establish the new technology for general immunoassays for all mammals_x000D_2. Generate data to secure extended patent rights_x000D_3. Produce prototype immunoassays attractive for the veterinary market _x000D_4. Develop methods for primary and secondary calibration of immunoassays for a range of species_x000D_5. Investigate and evaluate the potential veterinary market for acute phase proteins and other attractive biomarkers_x000D_6. Investigate and evaluate the potential veterinary market and prepare specifications for a suitable clinical chemistry platform _x000D_7. Identify a suitable clinical chemistry platform and adapt its technical features to requirements of the veterinary market_x000D__x000D_Project Goals:_x000D__x000D_1. Validate a robust mammalian CRP immunoassay (CRP = C-reactive protein, an acute phase protein)_x000D_2. Prepare primary and secondary CRP calibrators _x000D_3. Validate the CRP immunoassay and calibrators against a range of animal species_x000D_4. Use the acquired data to secure IP rights _x000D_5. Publish findings in the scientific literature_x000D_6. Extend the work in points 1-5 to at least one other acute phase protein (SAA = serum amyloid A)_x000D_7. Analyse national and global market opportunities based on animal segments; usage; species; rarity; health and welfare; animal rights; industrial production and traceability _x000D_8. Define strategies and applications for the distribution and marketing of mammalian immunoassays and educating veterinarians. _x000D__x000D_Consortium Ps: _x000D__x000D_Gentian Technology AS is a Norwegian company with expertise in antibody and immunoassay technology. _x000D_Roles include: Project coordinator; design and development of immunoassays and calibrators; reagent validation on multiple immunoassay platforms; and documentation _x000D__x000D_SLU (Swedish University of Agricultural Sciences) has expertise in large and small animals and clinical chemistry. _x000D_Roles include: Isolation and stabilization of body liquids for purification of canine, equine, bovine and porcine CRP and SAA; determination of references ranges; characterization of concentration ranges and immunoassay validation; publication of scientific articles_x000D__x000D_scil animal care company GmbH is one of the largest distributor of veterinary diagnostics in Europe and the US and has a global network of distribution Ps. _x000D_Roles include: market analysis according to species, segment, health, welfare and animal rights; market requirements; product specifications; marketing plans, distribution; education

Acronym Mammalian CRP (Reference Number: 5727)
Duration 01/06/2010 - 31/12/2013
Project Topic A new patented class of nanoparticle-based immunoturbidimetric assay reagents is invented. Universal CRP and SAA acute phase protein immunoassays will be validated and commercialized for all mammalian species. Lack of universal immunoassays is a major obstacle in veterinary diagnostics.
Project Results
(after finalisation)
A canine-specific CRP assay could be developed and scil is already been selling the product. Furthermore, scil animal care could identify and validate a wet-chemistry analyzer for analysis of clinical chemistry parameters in dogs, cats and horses. Scil is also selling this instrument.
Network Eurostars
Call Eurostars Cut-Off 4

Project partner

Number Name Role Country
3 Gentian Technology AS Coordinator Norway
3 Swedish University of Agricultural Sciences, Department of Clinical Sciences Partner Sweden
3 scil animal care company GmbH Partner Germany