Ordering Recommendation

Initial screening test for systemic autoimmune rheumatic diseases (ie, connective tissue diseases).

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum Separator Tube (SST).

Specimen Preparation

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

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Non-serum specimens. Contaminated, grossly hemolyzed, heat-inactivated, severely lipemic specimens.

Remarks
Stability

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

Methodology

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

Performed

Sun-Sat

Reported

1-8 days

Reference Interval

Test Number
Components
Reference Interval
  Antinuclear Antibody (ANA), HEp-2, IgG Less than 1:80

Interpretive Data

Refer to report.

Compliance Category

FDA

Note

The Antinuclear Antibody (ANA), IgG by IFA with Reflex by IFA Pattern begins with Nuclear Antibody (ANA) by IFA, IgG. Depending on findings, one or more reflexive tests may be required. Tests added may include Double-Stranded DNA (dsDNA) Antibody, IgG by ELISA; Double-Stranded DNA (dsDNA) Antibody, IgG by IFA (using Crithidiae luciliae); Chromatin Antibody, IgG; Smith/RNP (ENA) Antibody, IgG; Fibrillarin (U3 RNP) Antibody, IgG; Smith (ENA) Antibody, IgG; SSA 52 (Ro) (ENA) Antibody, IgG; SSA 60 (Ro) (ENA) Antibody, IgG; SSB (La) (ENA) Antibody, IgG; Scleroderma (Scl-70) (ENA) Antibody, IgG; PM/Scl-100 Antibody, IgG, by Immunoblot; and/or RNA Polymerase III Antibody, IgG. 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

86039; if homogenous or speckled pattern add 86235 x6, 86225, and 83516; if reflexed add 86256; If nucleolar pattern add 86235 x3 and 83516

Components

Component Test Code* Component Chart Name LOINC
3000090 Antinuclear Antibody (ANA), HEp-2, IgG 21424-7
3000096 ANA Interpretive Comment 49311-4
* 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

  • Antinuclear Antibody
  • FANA
  • Fluorescent Antinuclear Antibody
Antinuclear Antibody (ANA) with HEp-2 Substrate, IgG by IFA with Reflex by Pattern