Test Catalog

Test Id : CCP

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Cyclic Citrullinated Peptide Antibodies, IgG, Serum

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Overview

Test Catalog

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 inflammatory arthritis or connective tissue diseases

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Method Name
A short description of the method used to perform the test

Enzyme-Linked Immunosorbent Assay (ELISA)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Cyclic Citrullinated Peptide Ab, S

Aliases
Lists additional common names for a test, as an aid in searching

Anti Citrullinated Antibody

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

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Container/Tube:

Preferred: Serum gel

Acceptable: Red top

Specimen Volume: 0.5 mL

Special Instructions
Library of PDFs including pertinent information and forms related to the test

Forms

If not ordering electronically, complete, print, and send a General Request (T239) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.4 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

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

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

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 inflammatory arthritis or connective tissue diseases

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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 ultimate increase in morbidity, and mortality.(3,4)

 

Although late RA prognosis 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)

 

See Connective Tissue Disease Cascade (CTDC).

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 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
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 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.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Cross M, Smith E, Hoy D, et al: The global burden of rheumatoid arthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1316-1322

2. Aletaha D, Neogi T, Silman AJ, et al: 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010 Sep;62(9):2569-2581

3. Burgers LE, Raza K, van der Helm-van Mil AH: Window of opportunity in rheumatoid arthritis - definitions and supporting evidence: from old to new perspectives. RMD Open. 2019 Apr 3;5(1):e000870

4. Deane KD, Holers VM: Rheumatoid arthritis pathogenesis, prediction, and prevention: An emerging paradigm shift. Arthritis Rheumatol. 2021 Feb;73(2):181-193

5. Emery P, Breedveld FC, Dougados M, Kalden JR, Schiff MH, Smolen JS: Early referral recommendation for newly diagnosed rheumatoid arthritis: evidence based development of a clinical guide. Ann Rheum Dis. 2002 Apr;61(4):290-297

6. 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

7. Derksen VFAM, Huizinga TWJ, van der Woude D: The role of autoantibodies in the pathophysiology of rheumatoid arthritis. Semin Immunopathol. 2017 Jun;39(4):437-446

8. Hedstrom AK, Ronnelid J, Klareskog L, Alfredsson L: Complex relationships of smoking, HLA-DRB1 genes, and serologic profiles in patients with early rheumatoid arthritis: Update from a Swedish population-based case-control study. Arthritis Rheumatol. 2019 Sep;71(9):1504-1511

9. Verheul MK, Bohringer S, van Delft MAM, et al: Triple positivity for anti-citrullinated protein autoantibodies, rheumatoid factor, and anti-carbamylated protein antibodies conferring high specificity for rheumatoid arthritis: Implications for very early identification of at-risk individuals. Arthritis Rheumatol. 2018 Nov;70(11):1721-1731

10. Zhu JN, Nie LY, Lu XY, Wu HX: Meta-analysis: compared with anti-CCP and rheumatoid factor, could anti-MCV be the next biomarker in the rheumatoid arthritis classification criteria? Clin Chem Lab Med. 2019 Oct 25;57(11):1668-1679

Special Instructions
Library of PDFs including pertinent information and forms related to the test

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. 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)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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.

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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

86200

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
CCP Cyclic Citrullinated Peptide Ab, S 94874-5
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
CCP Cyclic Citrullinated Peptide Ab, S 94874-5

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports