Test Code #

B56

CPT Code(s) #

86431 x2, 86200

Test Name

Rheumatoid Arthritis Panel (includes Rheumatoid Factor – IgM & IgA and CCP)

If Profile, Includes Tests:

N/A

Disease Name:

Rheumatoid Arthritis

Type of Study:

Serum Studies

Methodology:

Fluoroenzyme immunoassay (FEIA)

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Substrate:

N/A

Reference Range:

Cyclic Citrullinated Peptide (CCP) (U/mL)
• Negative <7
• Equivocal 7-10
• Positive >10

Rheumatoid Factor (RF) (IU/mL)
IgM
• Negative <3.5
• Equivocal 3.5-5.0
• Positive >5

IgA
• Negative <14
• Equivocal 14-20
• Positive >20

Units:

IU/mL (International Units/ml), U/mL (Units/mL)

Schedule:

Assay performed once every week. Report availability is within one week from the time of specimen receipt

Specimen Requirements:

Collect 5-10 ml of blood in a red top or serum separator tube. If possible, separate serum from clot and place into red capped tube provided with Beutner Laboratories collection kits. If separation facilities are not available, the blood can be sent in the tube used for collection.

Sample Stability:

Sample is stable at ambient temperature during shipment. If sample is stored prior to shipment, it is stable refrigerated (2-8ºC) up to five days and frozen (-20ºC or lower) up to one year

Clinical Relevance:

Rheumatoid factor (RF) and Cyclic Citrullinated Peptide antibodies (ACPA) are serological biomarkers for diagnosis of Rheumatoid Arthritis (RA). Rheumatoid Factor (RF) is an autoantibody against the Fc portion of immunoglobulin (Ig). Rheumatoid factor IgM, the main isotype identified by RF assays, is found in approximately 70–80% of patients with confirmed RA. The presence of all three RF isotypes (IgG, IgA and IgM) at abnormal levels has high specificity for a diagnosis of RA. However, presence of RF isotypes in any combination may be found in other rheumatic conditions and in healthy individuals. The three RF isotypes (IgM, IgA, and IgG) are detected in 52% of RA patients but in fewer than 5% patients with other connective tissue diseases. Anti-CCP positivity, particularly at high levels, at any time is associated with higher risk of more severe clinical outcomes, higher disease activity and worse radiographic progression. Anti-CCP can also be present in other disease states. The second generation CCP (CCP2) test has high sensitivity and specificity and is currently recognized as the gold standard of testing for anti-CCP antibodies (ACPA). The accumulated specificity and sensitivity from 164 studies performed from 2002 to 2010 showed a sensitivity in early RA to be 61.6% and 75.2% in established RA and specificity of 94.0% (non-RA controls and 99.0% (healthy controls).