Geisinger Medical Laboratories Test Catalog

Order Display Name: Geisinger Epic Procedure Code Or ID CPT Code:  


Geisinger Epic Procedure Code: LAB3112             Geisinger Epic ID: 44052

Specimen type:
Preferred collection container:
Alternate Collection Container:
6 mL red-top (plain, non-serum separator) tube
Specimen required:
1.0 mL serum; minimum 0.5 mL

Specimen processing instructions:
Allow to clot. Centrifuge and submit 1 mL serum. 
Transport temperature:
Refrigerated (preferred). Room temperature (stable 8 hours) and frozen specimens also acceptable.
Specimen stability:
Room temperature: 8 hours. Refrigerated 2-8°C: 4 days (96 hours). Frozen: 6 months.
Rejection criteria:
Specimen stability exceeded; specimen grossly hemolyzed.

Reference interval:
dsDNA: Negative <20 IU/mL
ENA screen: Negative <0.7 Ratio
Interpretation guide:
    Negative <20 IU/mL
    Equivocal 20-45 IU/mL
    Positive >45 IU/mL
ENA screen:
    Negative <0.7 Ratio
    Equivocal 0.7-1.0 Ratio
    Positive >1.0 Ratio
CPT code(s):
Note: The billing party has sole responsibility for CPT coding.  Any questions regarding coding should be directed to the payer being billed.  The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only.
Test includes:
dsDNA Ab quantification and ENA Screen. Extractable nuclear antigens (ENA) Screen is based on recombinant U1-RNP (RNP70, A, C) SS-A/Ro, SS-B / La, Jo-1, Scl-70, Centromere B proteins and native purified Sm proteins as antigen. If ENA screen is positive, reflex to antibody testing (Sm + RNP, Cardiolipin IgG+M+A).
Enzyme Immunoassay (EIA)
SLE reflex panel
Clinical significance:
The presence of ANA antibodies in correlation with clinical findings and other laboratory tests can aid in the diagnosis of certain rheumatic diseases including systemic lupus erythematosus (SLE), Sjogren's syndrome, mixed connective tissue disease, scleroderma, and rheumatoid arthritis. High titers of antibodies to double-stranded DNA (dsDNA) are associated with systemic lupus erythematosus (SLE). The titer may decrease with successful therapy and increase in acute recurrence of the disease.Positive RNP and SM antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of SLE and other related connective tissue diseases. SM antibodies are highly specific for SLE and are detected in approximately 15% of patients with SLE.The presence of cardiolipin antibodies when used in conjunction with clinical findings and other laboratory tests can aid in assessing the risk of thromboembolic disease in patients with systemic lupus erythematosus (SLE) or primary anti-phospholipid syndrome (APS). However, a negative result does not rule out systemic rheumatic or other autoimmune disease. If clinically suspected, further evaluation and testing may be necessary.
Doctoral Director(s:)
Hoi-Ying Elsie Yu PhD, DABCC, FADLM    
Review Date: 12/13/2022

Performing Locations

Geisinger Medical Center

Performing laboratory: Immunology
Technical Lead: Kathy Hurst
Frequency: ANA IFA: Five days per week, 1st shift.
dsDNA: Five days per week, 1st shift.
RNPSM and Cardiolipin antibodies: Two days per week, 1st shift.
Performed STAT? No
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