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SeroNeg RAdx3 Profile (RDL)

CPT: 83516(x2); 83520
83520(x3)
83516(x2); 83520
Updated on 10/13/2021
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Expected Turnaround Time

7 - 10 days

7 - 10 days

7 - 10 days

7 - 10 days

7 - 10 days


Related Documents

For more information, please view the literature below.

Rheumatoid Arthritis: Novel Serologic Markers White Paper

For more information, please view the literature below.

Rheumatoid Arthritis: Novel Serologic Markers White Paper


Specimen Requirements


Specimen

Serum


Volume

3 mL


Minimum Volume

3 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 specimen; icteric specimen; non-serum specimen types


Test Details


Use

SeroNeg RAdx3 is a diagnostic and prognostic panel for Rheumatoid Arthritis designed to complement traditional RF and Anti-CCP testing.

This profile, consisting of 14-3-3 eta protein, Anti -CEP-1 Ab and Anti-Sa Ab, enhances the diagnosis of established or early RA (in individuals seronegative for RF and Anti-CCP Ab) and also helps predict disease severity.

Decrease in 14-3-3eta 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.


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)


LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
520209 SeroNeg RAdx3 Profile (RDL) REQUEST 520206 14.3.3 ETA, Rheum. Arthritis ng/mL 75880-5
520209 SeroNeg RAdx3 Profile (RDL) REQUEST 520207 Anti-CEP-1 Ab, IgG (RDL) Units 96561-6
520209 SeroNeg RAdx3 Profile (RDL) REQUEST 520208 Anti-Sa Ab, IgG (RDL) Units 54022-9

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CPT Statement/Profile Statement

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