Anti-CCP ELISA Kit (Anti-Cyclic Citrullinated Peptides)
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 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 this distinguishes 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. There is clinical evidence to indicate that citrullinated proteins are present in the bronchoalveolar lung fluid of smokers. These patients are also found to be suffering from joint pains. These patients will display a positive CCP antibody test yest with not have RA.
Anti-cyclic citrullinated peptides are present in approx. 70% of patients that are showing rheumatoid arthritis signs and these peptides are thought to have been present many years before any clinical RA was identified. 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.
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 CCP is bound to microwells.
- Calibrator A-F: Concentration 0, 20, 40, 100, 300, 1000 U/ml.
- Control Positive And Control Negative.
- 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
– 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
- Diagnosing early-onset rheumatoid arthritis: the role of anti CCP antibodies. Am Clin Lab. (2002) 21 (7): 34-6. Review. Vasishta A.
- 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.
- Antibodies against cyclic citrullinated peptides in infectious diseases–a systematic review. Clin Rheumatol. (2010) 29 (12): 1345-51. Review. Lima I. and Santiago M.
- 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 (Anti-Cyclic Citrullinated Peptides)
- Reactivity: Human
- Sample Type: Plasma, Serum
- Sensitivity: 1.0 U/ml
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