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  News May 26, 2008  

Fully-automated Anti-CCP assay launched by Roche Diagnostics

Roche Diagnostics has published the launch of a fully-automated immunoassay for the determination of autoantibodies to cyclic citrunillated peptides. The assay has been CE approved for use on the Elecsys / cobas e electrochemiluminescence immunoassay systems.

The results of the Anti-CCP assay are intended to be used as an aid in the diagnosis of Rheumatoid Arthritis (in combination with other clinical and laboratory findings). Rheumatoid arthritis is one of the most common autoimmune diseases, affecting 0.5-1% of the world population. This systemic disease is characterized by chronic inflammation of the synovial joints and progressive joint degeneration leading to loss of movement and to deformity over time. Early diagnosis of rheumatoid arthritis is important as early treatment may help to prevent joint damage and subsequent disability.

The diagnosis of rheumatoid arthritis relies on clinical symptoms and laboratory tests, such as rheumatoid factor and C-reactive protein. Anti-CCP is superior to both parameters in terms  of diagnostic specificity and predicts more severe disease course and outcome.

“We believe the Elecsys Anti-CCP plays an important role in the early diagnosis and treatment of rheumatoid arthritis and provides an excellent tool for primary care physicians and rheumatologists. The Elecsys Anti-CCP test marks another successful step in our strategy of offering the most comprehensive immunoassay test menu ”, said Dirk Ehlers, Head of Roche Professional Diagnostics.

 The newly developed second-generation Elecsys Anti-CCP assay has been shown to meet the diagnostic requirements with excellent sensitivity and specificity in a short total test time of 18 minutes. The fully-automated assay complements Roche Diagnostics broad immunoassay menu on Elecsys and cobas e platforms which permit the use of both routine and special assays.




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