Ordering Recommendation

Aids in initial diagnosis of connective tissue disease.


Qualitative Enzyme-Linked Immunosorbent Assay/Semi-Quantitative Indirect Fluorescent Antibody/Semi-Quantitative Multiplex Bead Assay/Semi-Quantitative Enzyme-Linked Immunosorbent Assay




1-5 days

New York DOH Approval Status

This test is New York DOH approved.

Specimen Required

Patient Preparation

Serum separator tube.

Specimen Preparation

Separate serum from cells ASAP or within 2 hours of collection. Transfer 1.0 mL serum to an ARUP Standard Transport Tube. (Min: 0.6 mL)

Storage/Transport Temperature


Unacceptable Conditions

Non-serum specimens. Contaminated, grossly hemolyzed, heat-inactivated, severely lipemic, specimens or inclusion of fibrin clots.


After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 month (avoid repeated freeze/thaw cycles)

Reference Interval

Test Number
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, histone, 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.

Compliance Category



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

Specimens are screened for ANA using ELISA. If ANA IgG is detected by ELISA, then Antinuclear Antibody (ANA), HEp-2, IgG by IFA will be added. If ANA, IgG by IFA is confirmed positive with a titer of 1:80 or greater, then a titer and pattern will be reported. In addition, samples positive for ANA, IgG by IFA will reflex to Double-Stranded DNA (dsDNA) Antibody, IgG by ELISA; Jo-1 Antibody, IgG; Smith/RNP (ENA) Antibody, IgG; Scleroderma (Scl-70) (ENA) Antibody, IgG; Smith (ENA) Antibody, IgG; SSA 52 and 60 (Ro) (ENA) Antibodies, IgG; and SSB (La) (ENA) Antibody, IgG. If Double-Stranded DNA (dsDNA) Antibody, IgG by ELISA is detected, then Double-Stranded DNA (dsDNA) Antibody, IgG by IFA (using Crithidia luciliae) 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; if reflexed, add 86235 x7 and 86225; if reflexed, add 86256


Component Test Code* Component Chart Name LOINC
0050080 Anti-Nuclear Ab (ANA), IgG by ELISA 29950-3
* 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.


  • ANA IgG panel
  • ANA IgG reflex
  • ANA panel
  • ANA reflex
  • ANA Reflexive Profile
  • ANA, dsDNA, RNP, Smith, SSA, SSB IgG
  • Antinuclear Antibody
  • FANA
  • Fluorescent Antinuclear Antibody
Antinuclear Antibodies (ANA), IgG by ELISA with Reflex to ANA HEp-2 Substrate, IgG by IFA and ENA Confirmation