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Specimen Collection Manual and Test Catalog

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ANTINUCLEAR ANTIBODY (ANA) SCREEN WITH REFLEXIVE ANTIBODIES QUANT

Geisinger Epic Procedure Code:  LAB1767    Geisinger Epic ID:  39212

SPECIMEN COLLECTION
Specimen type: 

Serum


Preferred collection container: 
Alternate collection container: 
6 mL red-top (plain, non-serum separator) tube
Specimen required: 

0.5 mL serum; minimum 0.2 mL



SPECIMEN PROCESSING
Processing instructions: 

Allow to clot. Centrifuge and submit 0.5 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.



TEST DETAILS
Reference interval: 

dsDNA: Negative <20 IU/mL 
ENA screen: Negative <0.7 Ratio


Interpretation guide: 

dsDNA: 
    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 


Additional information: 

Note: this test is useful in the setting of suspected autoimmune connective tissue disease, including systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sjögren's syndrome, systemic sclerosis and idiopathic inflammatory myopathies. It does not detect antibodies associated with autoimmune liver disease. In the setting of suspected AIH or PBC, "Antinuclear Antibody (ANA) IFA (LAB1768)" should be used.


CPT code(s):  86038
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 (SSA/Ro + SSB/La, Sm + RNP, Jo1, Scl70, Centromere).


Methodology: 
Enzyme Immunoassay (EIA)
Synonyms: 

ANAEIA, ANA, FANA, Fluorescent Antinuclear Antibody, Antinuclear antibody screen, SJOGRENS


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. 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): 
Benjamin Andress, PhD, DABCC
Hoi-Ying Elsie Yu, PhD, DABCC, FADLM
Review Date:  04/04/2025

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