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
Anti-MCV; Anti-CEP1 (citrullinated alpha-enolase 1) Ab; Anti-Sa (citrullinated vimentin) Ab; Anti-CarP (carbamylated protein) Ab
|
Anti-MCV; Anti-CEP1 (citrullinated alpha-enolase 1) Ab; Anti-Sa (citrullinated vimentin) Ab; Anti-CarP (carbamylated protein) Ab |
Use
SeroNeg RAdx4 is a diagnostic and prognostic panel for rheumatoid arthritis designed to complement traditional RF and anti-CCP testing. This profile, consisting of anti-MCV (mutated citrullinated vimentin) Ab, anti CEP-1 (citrullinated alphaenolase 1) Ab, anti-Sa (citrullinated vimentin) Ab and the novel anti-CarP (carbamylated protein Ab), enhances the diagnosis of established or early RA (especially in individuals seronegative for RF and anti-CCP Ab) and may also help predict disease severity. Decrease in anti-MCV Ab and/or anti-Sa Ab with treatment is associated with less radiographic progression. The presence of anti-CEP-1 and anti-CCP antibodies suggests the imminent progression of pre-clinical RA into 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.
SeroNeg RAdx4 is a diagnostic and prognostic panel for This profile, consisting of 14-3-3 eta protein, Anti-CEP1 (citrullinated alphaenolase 1) Ab, Anti-Sa (citrullinated vimentin) Ab, and the novel Anti-CarP (carbamylated protein) Ab, enhances the diagnosis of established or early RA (especially in individuals seronegative for RF and Anti-CCP Ab) and may also help predict disease severity. Decrease in 14-3-3 eta and/or Anti-Sa Ab with treatment is associated with less radiographic progression. The presence of Anti-CEP1 and Anti-CCP Antibodies suggests the imminent progression of pre-clinical RA into 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. |
SeroNeg RAdx4 is a diagnostic and prognostic panel for rheumatoid arthritis designed to complement traditional RF and anti-CCP testing. This profile, consisting of anti-MCV (mutated citrullinated vimentin) Ab, anti CEP-1 (citrullinated alphaenolase 1) Ab, anti-Sa (citrullinated vimentin) Ab and the novel anti-CarP (carbamylated protein Ab), enhances the diagnosis of established or early RA (especially in individuals seronegative for RF and anti-CCP Ab) and may also help predict disease severity. Decrease in anti-MCV Ab and/or anti-Sa Ab with treatment is associated with less radiographic progression. The presence of anti-CEP-1 and anti-CCP antibodies suggests the imminent progression of pre-clinical RA into 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 |
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.
Specimen Requirements
Specimen
Serum
Volume
3 mL
Minimum Volume
1.5 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
| Temperature | Period |
|---|---|
| Room temperature | 7 days |
| Refrigerated | 14 days |
| Frozen | 60 days |
| Freeze/thaw cycles | Stable x1 |
Storage Instructions
Refrigerate.
Causes for Rejection
Grossly hemolyzed; bacterial contamination; lipemic, icteric, non-serum specimen types
References
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 520305 | SeroNeg RAdx4 Profile | 520206 | 14.3.3 ETA, Rheum. Arthritis | ng/mL | 75880-5 | |
| 520305 | SeroNeg RAdx4 Profile | 520207 | Anti-CEP-1 Ab, IgG (RDL) | Units | 96561-6 | |
| 520305 | SeroNeg RAdx4 Profile | 520208 | Anti-Sa Ab, IgG (RDL) | Units | 54022-9 | |
| 520305 | SeroNeg RAdx4 Profile | 520317 | Anti-CarP Ab | Units | 66445-8 | |
| Order Code | 520305 | |||||
| Order Code Name | SeroNeg RAdx4 Profile | |||||
| Order Loinc | ||||||
| Result Code | 520206 | |||||
| Result Code Name | 14.3.3 ETA, Rheum. Arthritis | |||||
| UofM | ng/mL | |||||
| Result LOINC | 75880-5 | |||||
| Order Code | 520305 | |||||
| Order Code Name | SeroNeg RAdx4 Profile | |||||
| Order Loinc | ||||||
| Result Code | 520207 | |||||
| Result Code Name | Anti-CEP-1 Ab, IgG (RDL) | |||||
| UofM | Units | |||||
| Result LOINC | 96561-6 | |||||
| Order Code | 520305 | |||||
| Order Code Name | SeroNeg RAdx4 Profile | |||||
| Order Loinc | ||||||
| Result Code | 520208 | |||||
| Result Code Name | Anti-Sa Ab, IgG (RDL) | |||||
| UofM | Units | |||||
| Result LOINC | 54022-9 | |||||
| Order Code | 520305 | |||||
| Order Code Name | SeroNeg RAdx4 Profile | |||||
| Order Loinc | ||||||
| Result Code | 520317 | |||||
| Result Code Name | Anti-CarP Ab | |||||
| UofM | Units | |||||
| Result LOINC | 66445-8 |