Test Code #

045

CPT Code(s) #

86038, 86039, 86255, 86431 x2, 86235 x3

Test Name

Sjögren Syndrome Panel (includes ANA, RF, Ro, La, CENP)

If Profile, Includes Tests:

N/A

Disease Name:

Sjögren Syndrome

Type of Study:

Serum Studies

Methodology:

Indirect Immunofluorescence (HEp-2) and Fluoroenzyme immunoassay (FEIA)

Substrate:

N/A

Reference Range:

ANA (Titer)
• Negative <40

Rheumatoid Factor

IgM (IU/mL)
• Negative <3.5
• Equivocal 3.5-5.0
• Positive >5

IgA (IU/mL)
• Negative <14
• Equivocal 14-20
• Positive >20

Ro (SS-A) (U/mL)
• Negative <7
• Equivocal 7-10
• Positive >10

La (SS-B) (U/mL)
• Negative <7
• Equivocal 7-10
• Positive >10

CENP (U/mL)
• Negative <7
• Equivocal 7-10
• Positive >10

Units:

Titer, Units/mL, International Units/mL

Schedule:

Assay performed once per week. Report availability is within one week from the time of specimen receipt.

Specimen Requirements:

Collect 5-10 ml of blood in a red top or serum separator tube. If possible, separate serum from clot and place into red capped tube provided with Beutner Laboratories collection kits. If separation facilities are not available, the blood can be sent in the tube used for collection.

Sample Stability:

Stable at ambient temperature during shipment. If sample is stored prior to shipment, it is stable refrigerated (2-8ºC) up to five days and frozen (-20ºC or lower) up to one year.

Clinical Relevance:

Sjögren’s syndrome (SS) is a CTD affecting mainly women, and whose main feature is sicca syndrome. Various organs can be involved in severe forms. Classification criteria include both clinical and immunological parameters. Two different forms are observed: primary SS and secondary SS, which is associated with other CTD. Antinuclear antibody prevalence is estimated between 41.9 and 64% in this disease. The two main antigens recognized by AAb in SS patients are the Ro/SSA (with two subunits, one of 52 kDa and one of 60 kDa) and the La/SSB antigens. The detection of either anti-Ro/SSA and/or anti-La/SSB autoantibodies constitutes one of the classification criteria but their presence is not mandatory for diagnosis. Anti-Ro/SSA autoantibodies are detected in 33–77.1% of primary SS, whereas anti-La/SSB autoantibodies are present in 23–47.8% of primary SS.

References:

Didier K, Bolko L, Giusti D, Toquet S, Robbins A, Antonicelli F, Servettaz A. Autoantibodies Associated With Connective Tissue Diseases: What Meaning for Clinicians? Front Immunol. 2018 Mar 26;9:541.

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