Sign in →

Test Code CYCP 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 inflammatory arthritis or connective tissue diseases

Testing Algorithm

For more information see:

-Connective Tissue Disease Cascade

-Acquired Neuropathy Diagnostic Algorithm

Method Name

Enzyme-Linked Immunosorbent Assay (ELISA)

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum


Specimen Required


Collection Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Specimen Minimum Volume

0.4 mL

Specimen Stability Information

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

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus OK
Heat-treated specimen Reject

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) Performed

Monday through Saturday

CPT Code Information

86200

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CCP Cyclic Citrullinated Peptide Ab, S 33935-8

 

Result ID Test Result Name Result LOINC Value
CCP Cyclic Citrullinated Peptide Ab, S 33935-8

Clinical Information

Rheumatoid arthritis (RA) is a chronic systemic autoimmune disease characterized by interactions between the environment, specific genetic risk factors, and the human immune system. It affects about 0.6% of the US population with a global prevalence of 0.24%.(1) Clinically, RA is typified by progressive damage of synovial joints, inflammation, production of diverse autoantibodies, and variable extra-articular manifestations.(2-4) Patients with RA may be categorized based on the phase of disease (early versus established), presence or absence of antibodies (seropositive versus seronegative), clinical manifestations (joint erosion, interstitial lung disease, or cardiovascular), or specific risks (genes, gender, or smoking).(2-4) Delayed diagnosis of RA is associated with joint erosion, destruction or deformities, poor response to treatment with an ultimate increase in morbidity, and mortality.(3,4)

 

Although late RA diagnosis may be linked to adverse consequences, early diagnosis has been reported to improve outcomes; notably reduced joint destruction or deformity, delayed radiologic progression, and decreased functional disability.(3-5) To facilitate early diagnosis, the American College of Rheumatology/European League Against Rheumatism 2010 RA classification criteria recommend testing for rheumatoid factor (RF) and anticitrullinated protein antibodies (ACPA).(2) RF is an autoantibody directed against the Fc portion of immunoglobulin while ACPA are directed against peptides and proteins containing citrulline, a modified form of the amino acid arginine.(6,7) In addition to the use of RA and ACPA IgG to diagnose RA, RF and ACPA isotype antibodies and other serologic biomarkers have been used to predict if, and when, an individual who has inflammatory arthritis (IA) may develop future clinically apparent IA and access genetic and/or environmental risks.(3,4,8,9)

 

Compared to early serologic tests for RA including RF, several studies have demonstrated that ACPA have much improved specificity for RA.(4,6,10) A systemic review and meta-analysis of 33 studies including patients with RA and healthy or disease controls demonstrated the sensitivity of anti-mutated citrullinated vimentin, anticyclic citrullinated peptide, and RF of 71%, 71%, 77%, with the specificity of 89%, 95%, 73%, and the area under the curve of the summary receiver operating characteristic of 89%, 95%, 82%, respectively.(10) Based on these studies, there exist a subset of patients with RA who are negative for RF and ACPA IgG (seronegative) who must be diagnosed clinically or with use of emerging diagnostic tests.(4,7,9)

 

For more information see Connective Tissue Disease Cascade.

Interpretation

A positive result for cyclic citrullinated peptide (CCP) antibodies may be suggestive of rheumatoid arthritis (RA) if compatible clinical features of disease are present.

 

Significantly elevated levels of CCP antibodies may be useful to identify RA patients with erosive joint disease.

 

A Mayo Clinic 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).

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 a Mayo Clinic study (see Interpretation), 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.

Method Description

Cyclic citrullinated peptide (CCP) antibodies in serum are detected by binding to the wells of a commercial microtiter plate coated with synthetic CCP. During the first incubation, serum antibodies bind to adsorbed, solid phase CCP. The wells are then washed to remove unbound serum constituents, and horse radish peroxidase-labeled goat anti-human IgG antibody is added. After further incubation and washing to remove unbound conjugate, substrate (3,3',5,5' tetramethylbenzidine) is added and allowed to incubate. The reaction between enzyme and substrate is stopped and color in the wells is measured in a microtiter plate reader. The concentration of CCP antibodies is determined by comparison to a 5-point standard curve (15.6-250 U). Testing is performed on the Agility instrument by Dynex.(Package insert: Quanta Lite CCP3 IgG ELISA. INOVA Diagnostics; 02/2020)

Report Available

Same day/1 to 3 days

Test Classification

This test has been cleared, approved, or is exempt by the US 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.