Gold Standard Diagnostics Launches Axis-Shield’s New and Improved Anti-CCP2 Assay for Early and Accurate Diagnosis of Rheumatoid Arthritis

 In News

DAVIS, CA. December 6, 2011–Gold Standard Diagnostics, Corp. (GSD) a leading supplier of products and services to the medical diagnostic industry today announced the launch of Axis-Shield’s new and improved Anti-CCP2 assay in the U.S. Market. Axis-Shield’s FDA cleared Anti-CCP2 assay is a new, highly sensitive and specific second generation peptide based test that enables early and accurate diagnosis of rheumatoid arthritis.


The Anti-CCP2 assay is an ELISA which detects autoantibodies against second generation cyclic citrullinated peptides in human serum or plasma (CCP2). The test provides an additional tool in diagnosis and management of patients with rheumatoid arthritis (RA).

Key Features and Benefits of Anti CCP2:

  • Break-Apart Microwells- more convenience and cost effectiveness
  • Additional Standard at 300 U/ml-increased dynamic range with fewer samples falling outside the assay range
  • Anti CCP2 is the most sensitive and specific of the ACPA tests i
  • Anti CCP2 has Sensitivity 70-80% and Specificity >95% i

Background on CCP Antibodies:

Since the first report in 1998 that antibodies reactive with synthetic peptides containing the amino acid citrulline are highly specific for RA, the measurement of anti-CCP antibodies has become the method of choice in the accurate diagnosis of this disease. The anti-CCP2 assay is as sensitive as the rheumatoid factor test but with much higher specificity. Additionally anti-CCP2 positivity can predict future development of RA in both asymptomatic individuals and in patients with undifferentiated arthritis. It has also been shown that antibody levels at presentation can correlate with progression to erosive disease.

About Axis-Shield:

Axis-Shield is a pioneering organization focused on the development and manufacturing of important and innovative in vitro diagnostic tests for use in clinical laboratories and at the point of care. Axis-Shield is a innovator in CCP testing, developing the first CCP kit about 10 years ago. In the laboratory sector they specialise in proprietary markers for the early diagnosis and management of critical illnesses such as cardiovascular and neurodegenerative diseases, rheumatoid arthritis and diabetes.

About Gold Standard Diagnostics:

Gold Standard Diagnostics is a pioneer in providing products and services to the medical diagnostic industry. We partner with reagent and equipment manufacturers from around the world, creating innovative and cost effective diagnostics solutions for clinical and hospital laboratories. Gold Standard also develops its own suite of proprietary products that provide laboratories the next wave of technology-based solutions. More information is available at

i) Pruijin G et al, 2010; Arthritis Res Ther; 12:203

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