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Sjogren's Profile Plus (RDL)

CPT: 83520(x2); 86235(x2)

Test Includes

Anti-Ro (SS-A); Anti-La (SS-B); Anti-Fodrin Abs, IgG and IgA


Expected Turnaround Time

12 days


Specimen Requirements


Specimen

Serum


Volume

2 mL


Minimum Volume

0.5 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. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.


Storage Instructions

Refrigerate or freeze.


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

Anti-Ro (SS-A) antibodies occur in 40-50% of SLE, 60-75% of primary Sjogren's syndrome (PSS) and in a high proportion of secondary SS whether the associated disease is in SLE, RA, PSS, polydermato-myositis, or primary biliary cirrhosis, but is >90% of subacute cutaneous lupus and in vasculitis-associated SS.

Autoantibodies to SS-B/La antigen are detected by EIA in 70-90% of primary and about 50% of secondary Sjogren syndrome (SS) and as well as in 30% of SLE and 80% of subacute cutaneous lupus and a majority of infants with complete heart block.

Antibodies directed against alpha-fordin can be useful in diagnosing early stage Sjorgen's syndrome.


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)


Reference Interval

• Negative: <20

• Weak Positive: 20–39

• Moderate Positive: 40–80

• Positive: >80


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