An important assay used to aid in the diagnosis of rheumatoid arthritis (RA) will soon be available on Abbott's Architect immunoassay analyzers. The FDA has granted 510(k) clearance for an antibody cyclic-citrulinated peptide, or anti-CCP assay, to run on the world class systems.
Many patients with RA develop an immune response against proteins containing citrulline long before they present symptoms of the disease. Studies show detecting the level of these antibodies earlier in the disease continuum, in conjunction with other clinical information, is critical to the early diagnosis of the disease. The American College of Rheumatology treatment guidelines for RA recommends early diagnosis of the disease and timely introduction of therapies to prevent potentially irreversible joint damage.
The assay was developed by Axis-Shield to run on Abbott's Architect i1000SR and i2000SR systems. The anti-CCP assay is already approved and available on the Abbott Architect outside the United States.
"The approval of the anti-CCP assay for use on the Architect provides an important tool for physicians to aid in the early diagnosis of RA. We are pleased to add this assay to the existing panel of autoimmune disease biomarker assays currently available on the Architect and clinical chemistry platforms as we underscore Abbott’s continued commitment to the area of immunology," said Michael Warmuth, senior vice president, diagnostics, Abbott.
The Architect family of analyzers includes the i1000SR and i2000SR for immunoassay testing, the c4000, c8000, and c16000 for clinical chemistry testing, and the ci4100, ci8200, and ci16200 integrated immunoassay/chemistry systems.