Pharmacy News Article

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 (see also Arthritis).

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.

Important Product Usage and Safety Information

The ARCHITECT Anti-CCP assay is a chemiluminescent microparticle immunoassay (CMIA) for the semi-quantitative determination of the lgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma on the ARCHITECT i System. Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information. This product is for in vitro diagnostic use only. Use of this product requires the handling of human specimens, and it is recommended that all human-sourced materials be considered potentially infectious. This product contains sodium azide, and both the material and its container should be disposed of safely. Assay specific information is presented in the assay package insert which can be accessed at www.abbottdiagnostics.com once the product is available.