Test Details
Methodology
Enzyme-linked immunosorbent assay (ELISA); Turbidimetry
Result Turnaround Time
8 - 11 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
This test is reflexive. RF by Turbidimetry and Anti-CCP are performed and reported. If both are negative (i.e., <14 IU/mL and <20 Units, respectively), the SeroNeg RAdx4 (14-3-3 eta, Anti-CEP1, Anti-Sa, and Anti-CarP) is performed.
Use
This RA Profile with Reflex to SeroNeg RAdx4 is a novel profile for rheumatoid arthritis that if negative for traditional markers, RF and Anti-CCP, reflexes to 4 novel markers (14-3- eta, Anti-CEP1, Anti-Sa, Anti-CarP) that comprise SeroNeg RAdx4 which is designed to enhance diagnosis of RA and early RA as well as predict disease severity.
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 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
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 520298 | RA Profile Reflex to SeroNeg4 | 520093 | Rheumatoid Factor by Turb RDL | IU/mL | 11572-5 | |
| 520298 | RA Profile Reflex to SeroNeg4 | 520047 | Anti-CCP Ab, IgG + IgA (RDL) | Units | 57093-7 | |
| 520298 | RA Profile Reflex to SeroNeg4 | 520322 | Reflex Information | N/A | ||
| Order Code | 520298 | |||||
| Order Code Name | RA Profile Reflex to SeroNeg4 | |||||
| Order Loinc | ||||||
| Result Code | 520093 | |||||
| Result Code Name | Rheumatoid Factor by Turb RDL | |||||
| UofM | IU/mL | |||||
| Result LOINC | 11572-5 | |||||
| Order Code | 520298 | |||||
| Order Code Name | RA Profile Reflex to SeroNeg4 | |||||
| Order Loinc | ||||||
| Result Code | 520047 | |||||
| Result Code Name | Anti-CCP Ab, IgG + IgA (RDL) | |||||
| UofM | Units | |||||
| Result LOINC | 57093-7 | |||||
| Order Code | 520298 | |||||
| Order Code Name | RA Profile Reflex to SeroNeg4 | |||||
| Order Loinc | ||||||
| Result Code | 520322 | |||||
| Result Code Name | Reflex Information | |||||
| UofM | ||||||
| Result LOINC | N/A |
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 520319 | SeroNeg4 | 520262 | 14.3.3 ETA, Rheum. Arthritis | ng/mL | 75880-5 |
| Reflex 1 | ||||||
| Order Code | 520319 | |||||
| Order Name | SeroNeg4 | |||||
| Result Code | 520262 | |||||
| Result Name | 14.3.3 ETA, Rheum. Arthritis | |||||
| UofM | ng/mL | |||||
| Result LOINC | 75880-5 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 520319 | SeroNeg4 | 520263 | Anti-CEP-1 Ab, IgG (RDL) | Units | 96561-6 |
| Reflex 1 | ||||||
| Order Code | 520319 | |||||
| Order Name | SeroNeg4 | |||||
| Result Code | 520263 | |||||
| Result Name | Anti-CEP-1 Ab, IgG (RDL) | |||||
| UofM | Units | |||||
| Result LOINC | 96561-6 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 520319 | SeroNeg4 | 520264 | Anti-Sa Ab, IgG (RDL) | Units | 54022-9 |
| Reflex 1 | ||||||
| Order Code | 520319 | |||||
| Order Name | SeroNeg4 | |||||
| Result Code | 520264 | |||||
| Result Name | Anti-Sa Ab, IgG (RDL) | |||||
| UofM | Units | |||||
| Result LOINC | 54022-9 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 520319 | SeroNeg4 | 520317 | Anti-CarP Ab | Units | 66445-8 |
| Reflex 1 | ||||||
| Order Code | 520319 | |||||
| Order Name | SeroNeg4 | |||||
| Result Code | 520317 | |||||
| Result Name | Anti-CarP Ab | |||||
| UofM | Units | |||||
| Result LOINC | 66445-8 | |||||
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
|---|---|---|---|---|---|---|
| Reflex 1 | 520319 | SeroNeg4 | 520323 | Interpretation | N/A | |
| Reflex 1 | ||||||
| Order Code | 520319 | |||||
| Order Name | SeroNeg4 | |||||
| Result Code | 520323 | |||||
| Result Name | Interpretation | |||||
| UofM | ||||||
| Result LOINC | N/A | |||||