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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.
Submit With Order
ARUP Consult®
Disease Topics
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
Non-serum, heat inactivated, grossly hemolyzed and severly lipemic specimens. 
Remarks
 
Stability
After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles) 
Reference Interval
Effective November 13, 2017
Components
Reference Interval
Anti-Nuclear Antibodies (ANA), IgG by ELISANone Detected
Nuclear Antibody (ANA) by IFA, IgGLess than 1:80

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 than ANA IFA for systemic autoimmune rheumatic diseases (SARD).

Negative results do not necessarily rule our SARD.

Note
ANA lacks diagnostic specificity, and is associated with a variety of diseases (cancers, autoimmune, infectious, and inflammatory conditions) and occurs in healthy individuals in varying prevalence. The lack of diagnostic specificity requires a confirmation of positive ANA by more-specific serologic tests, which may be guided by the pattern(s) observed.

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

ANA determined by indirect fluorescence assay (IFA) use HEp-2 substrate and IgG-specific conjugate at a screening dilution of 1:80. If positive, patterns reported include homogeneous, speckled, centromere, nucleolar, nuclear dots, or cytoplasmic. All positive results are reported with endpoint titers.
CPT Code(s)
Components
Component Test Code*Component Chart NameLOINC
0050080Anti-Nuclear Ab (ANA), IgG by ELISA29950-3
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • ANA IgG Screen
  • ANA Screen
  • Antinuclear Ab