Rheumatoid Arthritis (RA) Profile with Reflex to SeroNeg RAdx4

CPT: 86200; 86431
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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 Turbidmetry 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-CaP) is performed.


Expected Turnaround Time

10 - 14 days



Related Documents


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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