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Our Vision is to improve healthcare as a global provider of innovative and reliable diagnostic tests. -
Our Mission is to identify and develop novel patentable diagnostic markers and technologies which can be commercialised to meet clinical needs, both in the laboratory and at the point of care. -
We will collaborate with partners, create branded products and identify complementary businesses which support our objective of continuing to grow as a respected and profitable healthcare company. -
Our Values include meeting all current and future regulatory, quality and environmental standards appropriate for our industry and the countries in which we operate.
Anti-CCP Assay
Axis-Shield produces an ELISA Kit described below:
The assay is also available on Abbott's AxSYM and ARCHITECT platforms and through Bio-Rad's BioPlex 2200 multianalyte system and the Zenit RA system from Menarini. It is also planned for launch on DPC's Immulite analyser and on Beckman Coulter systems
FCCP600
Description:
The Axis-Shield anti-CCP 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 the diagnosis and management of patients with rheumatoid arthritis (RA)
Background:
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.
Kit Components:
Each kit contains individually-coated microtitre strips (96 wells), reference and positive/negative controls, sample diluent, 6 standards, wash buffer, IgG-HRP conjugate, substrate and stop solution.
Assay Protocol:
The wells of the Axis-Shield anti-CCP microtitre strips are coated with highly-purified synthetic cyclic citrullinated peptides containing modified arginine residues (CCP2). In the quantitative protocol, the antibody concentration in an unknown sample can be estimated by interpolation from a dose response curve based on reference standards. In the qualitative protocol, the response measured in the unknown sample is compared to that of the known concentration reference control.
Performance:
In a sample group of 1036 sera from patients with clinically-confirmed RA, the sensitivity of the test was 78%, and the specificity was 97%. This compared to 74% and 53% for the RF IgM assay.
Pack Kit Size: 12 x 8 microtitre strips
Shelf Life: Minimum 12 months at 2-8 degrees C
| Related Papers |
| Anti-CCP Brochure (7.7MB PDF) |
*Products may not be approved for sale in all countries. Please contact your local distributor for further details.
Axis-Shield at a Glance
A pioneering organisation 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.
Focus on Afinion
Axis-Shield's award winning point-of-care test system is designed for maximum simplicity coupled with laboratory accuracy and reliability for a number of key markers important for improved patient management.
