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Test Code ANTI-CCP Cyclic Citrullinated Peptide Antibodies, IgG, Serum

Additional Codes

Mayo Test ID
CCP

Reporting Name

Cyclic Citrullinated Peptide Ab, S

Useful For

Evaluating patients suspected of having rheumatoid arthritis (RA)

 

Differentiating RA from other connective tissue diseases that may present with arthritis

Testing Algorithm

See Connective Tissue Disease Cascade (CTDC) in Special Instructions.

Performing Laboratory

Mayo Medical Laboratories in Rochester

Specimen Type

Serum

Specimen Required

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL

Forms: If not ordering electronically, complete, print, and send a General Request Form (T239) with the specimen (http://www.mayomedicallaboratories.com/media/customer-service/forms/general-request-form.pdf).

Specimen Minimum Volume

0.4 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 21 days
  Frozen  21 days

Reference Values

<20.0 U (negative)

20.0-39.9 U (weak positive)

40.0-59.9 U (positive)

≥60.0 U (strong positive)

Reference values apply to all ages.

Day(s) and Time(s) Performed

Monday through Saturday; 4 p.m.

Test Classification

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information

86200

LOINC Code Information

Result ID Reporting Name LOINC Code
CCP Cyclic Citrullinated Peptide Ab, S 32218-0

Clinical Information

Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic joint inflammation that ultimately leads to joint destruction. RA affects approximately 1% of the world's population. The diagnosis of RA is established primarily on clinical criteria and serologic findings. Historically, rheumatoid factor (RF), which is an antibody specific for the Fc portion of human IgG, has been considered a marker for RA. RF is, in fact, one of the diagnostic criteria for RA that was established by the American College of Rheumatology.(1) Although 50% to 90% of patients with RA are RF-positive, the specificity of the RF test is known to be relatively poor. RF is found in many patients with other autoimmune diseases, infectious diseases and some healthy individuals. Consequently, a search for better diagnostic markers, with improved specificity for RA, ensued. Antiperinuclear factor (APF) and antikeratin antibodies (AKA), identified by immunofluorescence, were found to have a specificity of close to 90% for RA, but testing for these autoantibodies has never become popular. It was subsequently determined that APF and AKA react with the same antigen, specifically a citrullinated form of filaggrin (citrulline is an unusual amino acid formed by posttranslational modification of arginine residues by the enzyme peptidyl arginine deaminase).(2) Recombinant filaggrin fragments, after enzymatic deamination in vitro, react with autoantibodies in RA sera. Synthetic cyclic citrullinated peptide (CCP) variants also react with anti-filaggrin autoantibodies and serve as the substrate for detecting anti-CCP antibodies serologically. Most studies of anti-CCP antibodies demonstrated that these autoantibodies have much improved specificity for RA compared to RF.(3)   

 

See Connective Tissue Diseases Cascade (CTDC) in Special Instructions; also see Optimized Laboratory Testing for Connective Tissue Diseases in Primary Care: The Mayo Connective Tissue Diseases Cascade in Publications.

Interpretation

A positive result for cyclic citrullinated peptide (CCP) antibodies indicates a high likelihood of rheumatoid arthritis (RA).

 

A Mayo prospective clinical evaluation of the CCP antibody test showed a diagnostic sensitivity for RA of 78% with fewer than 5% false positive results in healthy controls (see Cautions). CCP antibodies have also been reported in approximately 40% of seronegative RA patients, and, like rheumatoid factor (RF), a positive CCP antibody result indicates an increased likelihood of erosive disease in patients with RA.

 

High levels of CCP antibodies may be useful to identify patients with aggressive disease, but further studies are needed to document this association. The level of CCP antibodies may also correlate with disease activity in RA, but further studies are needed to document this clinical application.  

Cautions

Positive results for cyclic citrullinated peptide (CCP) antibodies may occur in some patients with systemic lupus erythematosus or other autoimmune, connective tissue diseases. In the Mayo study mentioned above, the false-positive rate in this subgroup was approximately 10%. 

 

Antirheumatic therapy should not be initiated based solely on a positive test for CCP antibodies, and changes in treatment should not be based upon the levels of CCP antibodies.

Analytic Time

Same day/1 day

Reject Due To

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

Mild OK; Gross OK

Other

NA

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)