Test ID: CCP
Cyclic Citrullinated Peptide Antibodies, IgG, Serum
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Useful For Suggests clinical disorders or settings where the test may be helpful
Evaluating patients suspected of having rheumatoid arthritis (RA)
Differentiating RA from other connective tissue diseases that may present with arthritis
Testing Algorithm Delineates situation(s) when tests are added to the initial order. This includes reflex and additional tests.
See Connective Tissue Disease Cascade (CTDC) in Special Instructions.
Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test
Method Name A short description of the method used to perform the test
Enzyme-Linked Immunosorbent Assay (ELISA)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
Anti Citrulline
Anti-CCP (Cyclic Citrullinated Peptide)
Anti-Citrullinated Ab
Anti-Citrullinated Antibody
Anti-Citrulline Antibody
Anti-Cyclic Citrullinated Peptide (CCP)
CCP (Cyclic Citrullinated Peptide)
Citrullinated Ab
Citrullinated Antibody
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Container/Tube:
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 0.5 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected
| Hemolysis | Mild OK; Gross reject |
| Lipemia | Mild OK; Gross reject |
| Icterus | Mild OK; Gross OK |
| Other | NA |
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
| Specimen Type | Temperature | Time |
|---|---|---|
| Serum | Refrigerated (preferred) | 21 days |
| Frozen | 21 days |
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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 Test-Ordering Algorithm in Special Instructions; also see Optimized Laboratory Testing for Connective Tissue Diseases in Primary Care: The Mayo Connective Tissue Diseases Cascade in Publications.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
<20.0 U (negative)
20.0-39.9 U (weak positive)
40.0-59.9 U (positive)
> or =60.0 U (strong positive)
Reference values apply to all ages.
Interpretation Provides information to assist in interpretation of the test results
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 Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
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.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Banal F, Dougados M, Combescure C, Gossec L: Sensitivity and specificity of the American College of Rheumatology 1987 criteria for the diagnosis of rheumatoid arthritis according to disease duration: a systemic literature review and meta-analysis. Ann Rheum Dis 2009 July;68:1184-1191
2. Schellekens GA, Visser H, De Jong BA, et al: The diagnostic properties of rheumatoid arthritis antibodies recognizing a cyclic citrullinated peptide. Arthritis Rheum 2000 Jan;43(1):155-163
3. Visser H, le Cessie S, Vos, K, et al: How to diagnose rheumatoid arthritis early: a prediction model for persistent (erosive) arthritis. Arthritis Rheum 2002 Feb;46(2):357-365
Method Description Describes how the test is performed and provides a method-specific reference
Cyclic citrullinated peptide (CCP) antibodies in serum are detected by binding to the wells of a commercial microtiter plate coated with synthetic CCP (Quanta Lite CCP3 IgG ELISA, INOVA Diagnostics). 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).(Package insert: Quanta Lite CCP3 IgG ELISA. INOVA Diagnostics. San Diego, CA)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Saturday; 4 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
86200
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
| Result ID | Reporting Name | LOINC Code |
|---|---|---|
| CCP | Cyclic Citrullinated Peptide Ab, S | 32218-0 |
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