Anti-Nuclear Antibodies (ANA), IgG by ELISA with Reflex to ANA, IgG by IFA
0050080
 
Ordering Recommendation
Aids in initial diagnosis of connective tissue disease.
Mnemonic
ANA
Methodology
Qualitative Enzyme-Linked Immunosorbent Assay/Semi-Quantitative Indirect Fluorescent Antibody
Performed
Sun-Sat
Reported
1-3 days
N/A
New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
 
Collect
Serum separator tube.  
Specimen Preparation
Separate serum from cells ASAP or within 2 hours of collection. Transfer 0.5 mL serum to an ARUP Standard Transport Tube. (Min: 0.3 mL)  
Storage/Transport Temperature
Refrigerated.  
Unacceptable Conditions
Plasma or urine. Contaminated, grossly hemolyzed, heat-inactivated, severely lipemic specimens or inclusion of fibrin clots.  
Remarks
 
Stability
After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)  
Reference Interval
Effective November 19, 2012
Test Number Components Reference Interval
Anti-​Nuclear Antibodies (ANA), IgG by ELISA None Detected
0050639 Nuclear Antibody (ANA) by IFA, IgG <1:40
Interpretive Data
Anti-Nuclear Antibodies (ANA), IgG by ELISA: ANA specimens are screened using enzyme-linked immunosorbent assay (ELISA) methodology. All ELISA results reported as Detected are further tested by indirect fluorescent assay (IFA) using HEp-2 substrate with an IgG-specific conjugate. The ANA ELISA screen is designed to detect antibodies against dsDNA, histone, SS-A (Ro), SS-B (La), Smith, snRNP/Sm, Scl-70, Jo-1, centromere, and an extract of lysed HEp-2 cells. ANA ELISA assays have been reported to have lower sensitivities for antibodies associated with nucleolar and speckled ANA-IFA patterns.
Note
ANA are not specific for systemic lupus erythematosus (SLE) but are found in a variety of rheumatic or connective tissue diseases. When cell culture substrates (HEp-2 cells) are used, the ANA incidence is greater than 90 percent in systemic lupus erythematosus (SLE), 80 percent in Sjogren syndrome and scleroderma, and 40 percent in juvenile idiopathic arthritis.

ARUP uses anti-human IgG conjugate since many (20-77 percent) healthy individuals have low levels (1:40 to 1:80) of ANA-IgM. Conversion of ANAs from IgM to IgG generally precedes the onset of autoimmune disease states. If clinical presentation is inconsistent with the ANA IFA result, consult ARUP for alternative testing.

If ANA are Detected by ELISA, then ANA by IFA titer will be added. Additional charges apply.


If ANA antibodies are detected by ELISA, then an IFA titer will be added. Additional charges apply
CPT Code(s)
86038; if reflexed, add 86039
Components
Component Test Code*Component Chart Name
0050080Anti-Nuclear Ab (ANA), IgG by ELISA
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, contact interface support at interface.support@aruplab.com.
Cross References
  • ANA IgG Screen
  • ANA Screen
  • Antinuclear Ab