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Test Code LABFSERO SeroNeg RAdx3 Profile

Additional Codes

Test Name in EPIC

EPIC Test Code

 Mayo Test ID
SeroNeg RAdx3 Profile LABFSERO FSERO

 


Specimen Required


Collection Container/Tube: 10 mL Red

Submission Container/Tube: Plastic vial

Specimen Volume: 3 mL

Acceptable: SST

Collection Instructions: Draw blood in a plain red-top tube(s), serum gel tube is acceptable. Spin down and send 3 mL of serum refrigerated in a plastic vial.


Method Name

ELISA

Reporting Name

SeroNeg RAdx3 Profile

Specimen Type

Serum

Specimen Minimum Volume

3 mL (volume does NOT allow for repeat testing)

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Refrigerated (preferred) 14 days
  Frozen  60 days
  Ambient  7 days

Reject Due To

Gross hemolysis: Reject
Thawing: Warm OK; Cold OK
Gross lipemia: Reject
Gross icterus Reject
Other: Anything other than serum; bacterial contamination

Clinical Information

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

Reference Values

Interpretation for:

14.3.3 ETA, Rheum. Arthritis:

Reference Range: <0.20 ng/mL

Negative:                <0.20 ng/mL

Weak Positive:       0.20-0.39 ng/mL

Moderate Positive: 0.40-0.79 ng/mL

Strong Positive:     >0.79 ng/mL

 

Interpretation for:

Anti-CEP-1 Ab, IgG and Anti-Sa Ab, IgG:

Reference Range: <20

Negative: <20 units

Weak Positive: 20-39 units

Moderate Positive: 40-80 units

Strong Positive: >80 units

Performing Laboratory

Esoterix Endocrinology

Test Classification

This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration.

CPT Code Information

83520

83516 x2

LOINC Code Information

Test ID Test Order Name Order LOINC Value
FSERO SeroNeg RAdx3 Profile Not Provided

 

Result ID Test Result Name Result LOINC Value
Z5779 14.3.3 ETA, Rheum. Arthritis 75880-5
Z5780 Anti-CEP-1 Ab, IgG 96561-6
Z5781 Anti-Sa Ab, IgG 54022-9

Day(s) Performed

Monday through Friday

Report Available

9 to 14 days