3665 – Anti-CCP

Highlights

  • Use of synthetic, cyclic, citrullinated peptides
  • Ready-to-use (exception: wash buffer), color and barcoded reagents
  • Quality assured handling in routine laboratories
  • Short incubation times (60 min / 30 min / 15 min) at room temperature
  • Quantitative determination of IgG antibodies
  • Calibrated using the international reference preparation IS 2723 of the CDC
  • Excellent diagnostic sensitivity and specificity
  • High precision within the measurement range
  • CE certified
  • Automatable

Intended Purpose

The Anti-CCP is a quantitative enzyme-linked immunosorbent assay (ELISA) for the determination of IgG antibodies against cyclic citrullinated peptides (CCP) in human serum. The Anti-CCP is intended as an aid in the diagnosis of rheumatoid arthritis (RA) in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.


Diagnostic Relevance

Rheumatoid arthritis is the most common inflammatory joint disease. It affects about 0.5 to 1.0 % of the world’s population. Painful joints in the fingers or toes are characteristic of rheumatoid arthritis, but knees, shoulders, hips or other joints may also be affected. The pain is often most cute in the morning. As the disease progresses, the number of joints affected usually increases.

The diagnosis of rheumatoid arthritis is based on the clinical symptoms, imaging methods and laboratory analysis. In routine diagnostics, the serological determination of rheumatoid factors is one of the classic and most frequently performed initial analyses. Rheumatoid factors are primarily IgM antibodies that target IgG antibodies and appear in most patients with rheumatoid arthritis. Clinicians consider them a sensitive marker for confirming the disease in the laboratory. However, rheumatoid factors also occur in other autoimmune diseases. Detecting rheumatoid factors alone does not prove the disease. Some patients with rheumatoid arthritis do not have detectable rheumatoid factors.

The Role of Anti-CCP Antibodies

Recently, the detection of antibodies against cyclic citrullinated proteins (CCP) has become increasingly important for the diagnosis of rheumatoid arthritis. Researchers first noticed that many patients with rheumatoid arthritis had antibodies against filaggrin. Further studies showed that these antibodies specifically target the citrullinated forms of filaggrin. The citrullination of proteins occurs enzymatically by deimination of arginine to citrulline. This modification is associated with a change in the charge state of the protein and thus in its structure and antigenic properties.

Immunoassays now use cyclic citrullinated peptides (CCP) with relevant epitopes instead of isolated filaggrin to detect specific IgG antibodies. Cyclizing synthetic peptides exposes the citrulline epitopes, which significantly improves the diagnostic performance, especially test specificity. Today, the determination of IgG antibodies against CCP serves as a specific and early marker for rheumatoid arthritis. In addition, the presence of CCP antibodies has a high prognostic value for an erosive course of the disease.

Product Specifications

Title Anti-CCP
Product code 3665
Indication Rheumatoid arthritis
Description Enzyme immunoassay for the quantitative determination of IgG antibodies against cyclic citrullinated peptides (CCP) in human serum
Format Microtiter plate coated with synthetic peptides with citrulline residues
Total incubation time 105 min.
Sample volume 10 µL serum
No. of determinations 96 (89 x 1) + 5 x Calibrators + 2 x Controls

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.