Key Features and Values

– Same sample type can be used across all assays to simplify inclusion into routine serology work-up
– Ready to use reagents reduces hands-on time for assay preparation
– Long shelf life cost-effective solution by reducing wastage due to expired kits
– Suitable for inclusion on automated plate systems simplifies scale-up of test volume
– Supported by a complete panel of assays for diagnosis of SLE and APS

Product Description

Anti CCP kit is an immunoenzymatic test (ELISA), intended for the quantitative determination of IgG class antibodies directed against cyclic citrullinated peptides, present in human serum or plasma.  Anti CCP kit is intended for laboratory use only.

Scientific Description
Reumathoid arthritis (RA) is one of the most common autoimmune diseases (1-2% European population).  The most significant clinical symptom is an inflammation of the synovial membranes which causes a painful swelling of the articulations and the ankylosis.  In order to correctly diagnose RA it is necessary to exclude other forms of arthritis: in such a diagnostic process, the laboratory plays an important role in the determination of Rheumatoid Factor (RF) antibodies of class IgM, detectable in 60-80% of the patients with RA.  The RF antibodies are sensitive but not very specific markers; on the contrary, Anti CCPs are characterised by a specificity of over 90% in patients affected by RA and are detectable in a very early asymptomatic stage in the approximately 70% of RA patients whereas only 2% of the control subjects gave a postivie result.  Therefore, the presence of Anti CCP antibodies can be used in the diagnosis of RA, particularly in the case of erosive arthritis, in childhood in the case of juvenile RA.  The test also appears, to be useful in differentiating the collagen pathologies with concomitant arthritis from the RA. The Anti CCP antibodies test has an important prognostic value in the monitoring of articular radiologically detectable damage. The kit’s quantitative determination is useful in the control and verification of the effects of pharmacological therapy.
The Anti CCP antibody test, together with the determination of RF, increases the ratio of sensitivity /specificity.  20% of the RAs are RF-negative and 15/20% of the RAs are positive only to RF.  The simultaneous positive result of a sample to RF and CCP has a positive predictive value of about 100%.
The levels of Anti CCP antibodies are not necessarily correlated to the evolutionary stage of the illness.  The advantage of the Anti CCP antibodies is that they are detectable in the patient sera up to 10 years prior to the appearance of symptoms.  In addition, in cases of early arthritis a positive test result, according to some studies is related to the development of bone erosive lesions of the articulations.

1. Bizzaro N. et al. Diagnostic Accuracy of the anticitrulline antibody assay for rheumatoid arthritis. Clin Chem 47:6, 1089-1093,2001
2. Schellekens G. et al. The diagnostic properties of rheumatoid arthritis antibodies recognizing a cyclic citrullinated peptide. Arthritis Rheum 43:155-163 (2000)
3. Baeten D. et al. Specific presence of intracellular citrullinated proteins in rheumatoid arthritis synovium. Arthritis Rheum 44:2255-2262 (2001)
4. del Val del Amo N, Ibanez Bosch R, Fito Manteca C, et al. Anti-cyclic citrullinated peptide antibody in rheumatoid arthritis: relation with disease
aggressiveness. Clin Exp Rheumatol. 2006;24(3):281-6
5. Samanci N, Ozdem S, Akbas H, et al. Diagnostic value and clinical significance of Anti CCP in patients with advancedrheumatoid arthritis. J Natl Med Assoc. 2005;97(8):1120-6
6. Matsui T, Shimada K, Ozawa N, et al. Diagnostic utility of anti-cyclic citrullinated peptide antibodies for very early rheumatoid arthritis. J Rheumatol. 2006;33(12):2390-7
7. Bizzaro N, Villalta D, Tozzoli R, et al. Validazione del primo Calibrator internazionale WHO per gli anticorpi anti-Peptidi Citrullinati RiMEL/IJLaM 2008; 4(suppl): F23 – 203
8. Kroot EJ, De Jong BA, Van Leeuwen MA, Swinkels H, Van den Hoogen FH, Van’t Hof M, et al. The prognostic value of anti-cyclic citrullinate peptide antibody in patients with recent-onset rheumatoid arthritis. Arthritis Rheum 2000; 43: 1831-5.

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Code: DKO117
Clinical Area: ,
Incubation: 60+30+15 min
Sensitivity: 79%
Specificity: 97%
Classification: IVD, CE
Number of Tests: 96
Sample Type: Serum, heparin plasma, EDTA plasma
Sample Volume: 10 µL (1:100 predilution)
Assay Range: N/A