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RAdx6 Profile

CPT: To be determined. Updates will be made when available.
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Test Includes

RF by Turb; Anti-CCP (Cyclic Citrullinated Peptide) Ab, IgG & IgA; 14.3.3 eta; Anti-CEP1 Ab, IgG; Anti-Sa Ab; Anti-CEP1 (citrullinated alpha-enolase 1) Ab; Anti-Sa (citrullinated vimentin) Ab; Anti-CarP (carbamylated protein) Ab


Expected Turnaround Time

10 - 12 days


Related Documents

For more information, please view the literature below.

Rheumatoid Arthritis: Novel Serologic Markers White Paper


Specimen Requirements


Specimen

Serum


Volume

3 mL


Minimum Volume

1 mL (Note: This volume does not allow for repeat testing.)


Container

Red-top tube or gel-barrier tube


Collection

Separate serum from cells within one hour of collection. Transfer to a plastic transport tube before shipping.


Storage Instructions

Refrigerate.


Stability Requirements

Temperature

Period

Room temperature

7 days

Refrigerated

14 days

Frozen

60 days

Freeze/thaw cycles

Stable x1


Causes for Rejection

Grossly hemolyzed; bacterial contamination; lipemic, icteric, non-serum specimen types


Test Details


Use

The RAdx6 is a novel comprehensive diagnostic and prognostic panel for rheumatoid arthritis available exclusively at RDL. It combines 4 novel markers (14-3-3n, anti-CEP-1 anti-Sa and anti-CarP) with 2 traditional marker anti-CCP and RF) to not only enhance the diagnosis of RA in early or established disease, but also to help predict disease severity. If 14-3-3n and/or anti-Sa positivity is present, the disappearance or decrease of these antibodies with treatment is associated with less radiographic progression. In pre-clinical RA, positivity of anti-CEP-1 along with anti-CCP antibodies significantly raises the risk of imminently developing clinical RA.

Anti-CarP may predict the development of RA independently of Anti-CCP and may be present years before the onset of symptoms in RA. Anti-CarP may confer a 10% incremental benefit in identify early RA and is associated with more active disease and higher risk of developing joint erosions.


Limitations

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.


Methodology

Enzyme-linked immunosorbent assay (ELISA)


References

Truchetet ME, Dublanc S, Barnetche T, et al. Association of the Presence of Anti- Carbamylated Protein Antibodies in Early Arthritis with a Poorer Clinical and Radiologic Outcome. Arthritis Rheumatol. 2017 Dec;69(12):2292-2302.28853240

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
520304 RAdx6 Profile 520226 Anti-CCP Ab, IgG & IgA (RDL) Units 57093-7
520304 RAdx6 Profile 520093 Rheumatoid Factor by Turb RDL IU/mL 11572-5
520304 RAdx6 Profile 520262 14.3.3 ETA, Rheum. Arthritis ng/mL 75880-5
520304 RAdx6 Profile 520263 Anti-CEP-1 Ab, IgG (RDL) Units 96561-6
520304 RAdx6 Profile 520264 Anti-Sa Ab, IgG (RDL) Units 54022-9
520304 RAdx6 Profile 520317 Anti-CarP Ab Units Pending

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