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Rheumatoid Arthritis (RA) Profile with Reflex to SeroNeg RAdx4
CPT:
86200; 86431
Synonyms
- RA Profile (Rheumatoid Factor and Anti-CCP) with Reflex to SeroNeg RAdx4 (14-3-3 eta, Anti-CEP1, Anti-Sa, Anti-CarP)
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.
Expected 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.
Related Information
Related Documents
For more information, please view the literature below.
Rheumatoid Arthritis: Novel Serologic Markers White Paper
Rheumatoid Arthritis Testing With Better Performance Brochure
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
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.
Methodology
Enzyme-linked immunosorbent assay (ELISA); Turbidimetry
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 |
| Reflex Table for Reflex Information | ||||||
|---|---|---|---|---|---|---|
| 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 Table for Reflex Information | ||||||
|---|---|---|---|---|---|---|
| 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 Table for Reflex Information | ||||||
|---|---|---|---|---|---|---|
| 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 Table for Reflex Information | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 520319 | SeroNeg4 | 520317 | Anti-CarP Ab | Units | 66445-8 |
| Reflex Table for Reflex Information | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 520319 | SeroNeg4 | 520323 | Interpretation | N/A | |
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CPT Statement/Profile Statement
The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf