Anti-Cyclic Citrullinated Peptide
Label Mnemonic: CCP
Epic code: LAB1254
Downtime form: A-1a Doctor/Provider Orders - Pathology Core and Specialty Care Nursery
Chemistry
6240 RCP
356-3527
Specimen(s):
Serum
Collection Medium:
Red top tube 5 mL (Clot Activator)
Alternate Collection Media:
Call laboratory for additional acceptable specimen collection containers.
Minimum:
3 mL; red top or TWO Microtainer® devices
Rejection Criteria:
Hemolyzed and plasma samples are NOT acceptable
Delivery Instructions:
Deliver to laboratory within 2 hours of collection.
Testing Schedule:
24 hrs/day, 7 days a week, including holidays.
Turn Around Time:
2 hours (upon receipt in laboratory)
Reference Range:
<17 U/mL
Interpretive Data:
This assay may be significantly impacted by high-dose biotin (>5 mg dose) taken within previous 12 hours. High concentrations of biotin may lead to falsely decreased results. These concentrations may be found in patients taking over-the-counter supplements with biotin content much higher than nutritional requirements for biotin. Specimens should not be collected until at least 12 hours after the last dose.
Comments:
Assay methodology and reference range changed May 9, 2023 to the Roche Elecsys Anti-CCP assay. This assay detects IgG antibodies against a set of cyclic citrullinated peptides.

A positive result for cyclic citrullinated peptide (anti-CCP) antibodies indicates a high likelihood (specificity >95%) of rheumatoid arthritis (RA). Anti-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. A cut-off of 17 U/mL yielded a sensitivity of 67% in a cohort of 792 confirmed RA patients.

Anti-CCP values determined on patient samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.

References:
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
Test Limitations:
The assay is unaffected by icterus (bilirubin is less than 25 mg/dL), lipemia (triglycerides is less than 1500 mg/dL), hemolysis (Hb less than 500 mg/dL) and biotin is less than 70 ng/mL. Criterion: For concentrations of 8-25 U/mL the deviation is ≤5 U/mL. For concentrations >25 U/mL the deviation is ≤15%.

Interference from pathologic levels of unspecific IgG cannot be excluded. False negative results can be seen in patients with hypergammaglobulinemia.

Contaminated, icteric, lipemic, hemolyzed, or heat inactivated sera may cause erroneous results and should be avoided.
Methodology:
Electrochemiluminescence Immunoassay
CPT Code:
86200