RAdx6 Profile
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.
Special Instructions
Not provided.
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, which means results should be interpreted with this context in mind. Disparities in results could arise due to variations in testing conditions, cross-reactivity, or interference from factors such as hemolysis, lipemia, or bacterial contamination. The presence of antibodies does not confirm diagnosis independently; results should be used in the context of clinical presentation.
Methodology
Immunoassay (ELISA)
Biomarkers
LOINC Codes
- 57093-7 - cCP IgA+IgG SerPl IA-aCnc
- 11572-5 - Rheumatoid fact SerPl-aCnc
- 54022-9 - Mut cit vimentin Ab Ser-aCnc
- 96561-6 - CEP-1 Ab Ser IA-aCnc
- 66445-8 - Carp (rCyp c) 1 IgE Qn
Result Turnaround Time
7-12 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
3 mL
Minimum Volume
1 mL
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.
Storage Instructions
Refrigerate.
Causes for Rejection
Grossly hemolyzed; bacterial contamination; lipemic, icteric, non-serum specimen types
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 7 days |
| Refrigerated | 14 days |
| Frozen | 60 days |
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