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Anti-CCP ELISA Kit

INTENDED USE

Human anti-CCP ELISA kit is designed for measuring in vitro quantitative levels of IgG class of autoantibodies against anti cyclic citrullinated peptides (anti-CCP, CCP antibody, anti CCP) in human plasma and serum. This assay has a minimum analytical sensitivity limit of 1.0 U/ml.

BACKGROUND

Rheumatoid arthritis (RA) is a common chronic systemic autoimmune disease which can lead to significant clinical symptom such as inflammation of the joints which can result in the gradual damage and loss of their function. There are many treatments that can be used in order to minimise RA complications, however, this all depends on making an early and accurate diagnosis. Rheumatoid factor (RF) is the most common autoantibody test which has been used to diagnosis of RA and also distinguish it from many other inflammatory processes and types of arthritis. One drawback for the RF antibodies is that they are sensitive but not very specific markers, whereas CCP (cyclic citrullinated peptides) provide a much more specific diagnosis of RA and can be detected in a very early asymptomatic stage.

The following assay can be useful in differentiating the collagen pathologies with concomitant arthritis from the RA and in providing an important prognostic value in monitoring articular radiologically detectable damage. Anti cyclic citrullinated peptides autoantibodies are found to be present in approx. 70% of patients having rheumatoid arthritis and it is thought to exist in a patient for many years before they develop any clinical rheumatoid arthritis symptoms. This means that a positive anti-CCP test can help to deliver a prognosis since many patients with positive cyclic citrullinated peptides antibody results experience severe rheumatoid arthritis symptoms.

ANTI-CCP ELISA KIT CONTENT

All reagents supplied need to be stored at 2 °C – 8 °C, unopened reagents will retain reactivity until expiration date. Do not use reagents beyond this date.

  • Divisible Microplate: Consisting of 12 modules of 8 wells each, highly purified anti cyclic citrullinated peptides is bound to microwells.
  • Calibrator A-F: Concentration 0, 20, 40, 100, 300, 1000 U/ml, made up from human anti-CCP.
  • Control Positive And Control Negative: Containing anti CCP antibodies in a serum/buffer matrix.
  • Sample Buffer P (5x).
  • Enzyme Conjugate: Contains anti-human IgG antibodies, HRP labelled.
  • TMB Substrate.
  • Stop Solution: Contains acid.
  • Wash Buffer (50x).
  • Instruction for Use.
  • Certificate of Analysis.

SENSITIVITY

The minimum detection sensitivity level of anti cyclic citrullinated peptides (anti CCP, anti-CCP, CCP antibody) using current anti-CCP ELISA kit was 1.0 U/ml. The dynamic range for this assay is 20.0 – 1,000.0 U/ml.

ASSAY CHARACTERISTICS

– Anti Cyclic Citrullinated Peptides (Anti-CCP): ELISA
– Measuring Range: 0 – 1000 U/ml
– Expected Values: Healthy blood donors display a cut-off 20 U/ml
– Results Interpretation: Negative: < 20 U/ml, Positive ≥ 20 U/ml
– Intra Assay: 7.8 – 13.6%
– Inter Assay: 6.1 – 9.3%
– Linearity: 95 – 120%
– Sensitivity: 1.0 U/ml.
– Interfering Substances: None
– Clinical Diagnosis: Sensitivity (91.5%), Specificity (95.5%), Overall agreement (93.1%).

REFERENCES

  1. Diagnosing early-onset rheumatoid arthritis: the role of anti CCP antibodies. Am Clin Lab. (2002) 21 (7): 34-6. Review. Vasishta A.
  2. Rheumatoid factor and anti-CCP autoantibodies in rheumatoid arthritis: a review. Clin Lab Sci. (2008) 21 (1): 15-8. Review. Lee A.N., et al.
  3. Antibodies against cyclic citrullinated peptides in infectious diseases–a systematic review. Clin Rheumatol. (2010) 29 (12): 1345-51. Review. Lima I. and Santiago M.
  4. Anti-citrullinated protein antibodies and their clinical utility in rheumatoid arthritis. Int J Rheum Dis. (2013) 16 (4): 379-86. Review. Farid S.Sh., et al.
  5. Anti-CCP Antibody, a Marker for the Early Detection of Rheumatoid Arthritis. Ann N Y Acad Sci. (2008) 1143: 268-85. Review. van Venrooij W.J., et al.

ADDITIONAL INFORMATION

  • Full Name: Anti-CCP ELISA Kit
  • Reactivity: Human
  • Sample Type: Plasma, Serum
  • Sensitivity: 1.0 U/ml

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