New ELISA test to detect antibodies against citrullinated peptides for rheumatoid arthritis diagnosis and prognosis
Antibodies to citrullinated (arginine is replaced by a citrulline) proteins/peptides are the most specific serological markers for diagnosing RA.
The invention consists in an ELISA assay based on three chimeric citrullinated synthetic peptides from filaggrin and the chain of fibrin as antigenic substrates.
This assay has been tested in more than 900 sera of patients with RA, erythematosus systemic lupus, psoriatic arthritis, chronic virus C – hepatitis and of healthy persons, establishing a specificity of 98%, sensitivity of 72-78% (80% when considered together) and positive predictive values greater than 97%.
· It shows high sensitivity and specificity for RA in an early stage of disease.
· Ability to detect RA in the sera of patients that were no detected using the CCP2 test.
· Antibodies to these peptides can be good markers in patients with poor radiographic outcome and that need more aggressive therapy from the beginning of the diagnostic.
· Very useful in combination with other peptides to increase sensitivity in the identification of particular subsets of RA patients.
Tested as an electrochemical immunosensor for further evelopment of an automated, point-of care, rapid and low-cost diagnostic device.
Estado de protección
PCT/ES2008/070087 "Citrulinated fibrin-filaggrin chimeric polypeptide capable of detecting the antibodies generated in rheumatoid arthritis" Granted in Spain, UK, Germany, Netherlands, France, Sweden and US. Applicants: CSIC and FCRB
Cooperación que se desea
CSIC is leading the commercialization of this project and is seeking an industrial partner for licensing out and further develop this technology
- Tecnología sanitaria:
- Biotecnología y Diagnóstico Molecular (proteómica, genómica, etc...)