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RAdx6 Profile

CPT

83516(x3); 83520; 86200; 86431

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  • Updated on 03/24/2025

Test Details

Methodology

Enzyme-linked immunosorbent assay (ELISA)

Result Turnaround Time

7 - 10 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Test Includes

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

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

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

Use

The RAdx6 is a novel comprehensive diagnostic and prognostic panel for rheumatoid arthritis available exclusively at RDL. It combines 4 novel markers (Anti-MCV, 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 anti-MCV 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 identifying early RA and is associated with more active disease and higher risk of developing joint erosions.

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.

The RAdx6 is a novel comprehensive diagnostic and prognostic panel for rheumatoid arthritis available exclusively at RDL. It combines 4 novel markers (Anti-MCV, 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 anti-MCV 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 identifying 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.

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

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 Instructions

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

Stability Requirements

TemperaturePeriod
Room temperature7 days
Refrigerated14 days
Frozen60 days
Freeze/thaw cyclesStable x1

Storage Instructions

Refrigerate.

Causes for Rejection

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

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 66445-8
Order Code520304
Order Code NameRAdx6 Profile
Order Loinc
Result Code520226
Result Code NameAnti-CCP Ab, IgG + IgA (RDL)
UofMUnits
Result LOINC57093-7
Order Code520304
Order Code NameRAdx6 Profile
Order Loinc
Result Code520093
Result Code NameRheumatoid Factor by Turb RDL
UofMIU/mL
Result LOINC11572-5
Order Code520304
Order Code NameRAdx6 Profile
Order Loinc
Result Code520262
Result Code Name14.3.3 ETA, Rheum. Arthritis
UofMng/mL
Result LOINC75880-5
Order Code520304
Order Code NameRAdx6 Profile
Order Loinc
Result Code520263
Result Code NameAnti-CEP-1 Ab, IgG (RDL)
UofMUnits
Result LOINC96561-6
Order Code520304
Order Code NameRAdx6 Profile
Order Loinc
Result Code520264
Result Code NameAnti-Sa Ab, IgG (RDL)
UofMUnits
Result LOINC54022-9
Order Code520304
Order Code NameRAdx6 Profile
Order Loinc
Result Code520317
Result Code NameAnti-CarP Ab
UofMUnits
Result LOINC66445-8