Antinuclear Antibodies (ANA), IgG by ELISA with Reflex to ANA, HEp-2 Substrate, IgG by IFA
Ordering Recommendation
Aids in initial diagnosis of connective tissue disease.
New York DOH Approval Status
Specimen Required
Serum Separator Tube (SST).
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)
Refrigerated.
Non-serum, heat inactivated, grossly hemolyzed, or severely lipemic specimens.
After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles)
Methodology
Qualitative Enzyme-Linked Immunosorbent Assay/Semi-Quantitative Indirect Fluorescent Antibody
Performed
Sun-Sat
Reported
1-3 days
Reference Interval
Test Number |
Components |
Reference Interval |
---|---|---|
Anti-Nuclear Ab (ANA), IgG by ELISA | None detected |
Interpretive Data
Antinuclear 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, histones, SS-A (Ro), SS-B (La), Smith, Smith/RNP, Scl-70, Jo-1, centromeric proteins, and other antigens extracted from the HEp-2 cell nucleus. 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 out SARD.
FDA
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 Antinuclear Antibody (ANA), HEp-2, IgG by IFA will be added. Additional charges apply
ANA identified by indirect fluorescence assay (IFA) using HEp-2 substrate and IgG-specific conjugate at a screening dilution of 1:80. Positive nuclear patterns reported include homogeneous, speckled, centromere, nucleolar, or nuclear dots. Positive cytoplasmic patterns reported include reticular/AMA, discrete/GW body-like, polar/golgi-like, rods and rings, or cytoplasmic speckled patterns. All positive results are reported with endpoint titers at no additional charge.
Hotline History
CPT Codes
86038; if reflexed, add 86039
Components
Component Test Code* | Component Chart Name | LOINC |
---|---|---|
0050080 | Anti-Nuclear Ab (ANA), IgG by ELISA | 29950-3 |
Aliases
- ANA IgG Screen
- ANA Screen
- Antinuclear Ab