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

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Serum Separator Tube (SST).

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, or severely 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 ELISA None Detected
Antinuclear Antibody (ANA), HEp-2, IgG Less than 1:80

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.

Compliance Category

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
N/A
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
* 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
Antinuclear Antibodies (ANA), IgG by ELISA with Reflex to ANA, HEp-2 Substrate, IgG by IFA