Chemiluminescent Microparticle Immunoassay Helps Diagnose Rheumatoid Arthritis

A chemiluminescent microparticle immunoassay (CMIA) provides semiquantitative determination of the Immunoglobin G (IgG) class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma. This product is for in vitro diagnostic use only.

Many patients with rheumatoid arthritis (RA) develop an immune response against proteins containing citrulline long before they present symptoms of the disease. 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 new assay was developed by Axis-Shield (Dundee, UK) to run on Abbott's (Abbott Park, IL, USA) Architect i1000SR and i2000SR systems. The US Food and Drug Administration (FDA; Silver Spring, MD, USA) has granted 510(k) clearance for an antibody cyclic-citrullinated peptide, or chemiluminescent microparticle immunoassay to run on the Architect systems. The anti-CCP assay is already approved and available on the Abbott Architect systems outside the United States.

Abbot's 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. Abbott's technologies include the Robotic Sample Handler to prioritize emergency tests; sample clot and bubble detection to verify sampling integrity; and FlexRate and ChemiFlex assay technologies. Architect systems use identical easy-to-use software and common reagents across all members of the family.

Abbott Diagnostics offers a broad range of innovative instrument systems and tests for hospitals, reference labs, blood banks, physician offices, and clinics. The company's diagnostic products offer customers automation, convenience, cost effectiveness, and flexibility. Abbott develops treatments and diagnostics for immunologic diseases, including rheumatoid arthritis. The Architect integrated platform provides RA testing including anti-CCP, Rheumatoid Factor, and C-reactive protein (CRP).

Related Links:
Axis-Shield
Abbott
US Food and Drug Administration