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Antinuclear Antibody (ANA) with HEp-2 Substrate, IgG by IFA

ANA IFA AB
Example Reports
Detected
None Detected

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Additional Technical Information

Ordering Recommendation

Preferred ANA screening test for systemic autoimmune rheumatic disease (ie, connective tissue disease).

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 1 mL serum to an ARUP standard transport tube. (Min: 0.15 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Plasma. Contaminated, hemolyzed, or severely lipemic specimens.

Remarks
Stability

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

Methodology

Semi-Quantitative Indirect Fluorescent Antibody (IFA)

Performed

Sun-Sat

Reported

1-3 days

Reference Interval

Less than 1:80

Interpretive Data

Presence of antinuclear antibodies (ANA) is a hallmark feature of systemic autoimmune rheumatic diseases (SARD). However, ANA lacks diagnostic specificity and is associated with a variety of diseases (cancers, autoimmune, infectious, and inflammatory conditions) and may also occur in healthy individuals in varying prevalence. The lack of diagnostic specificity requires confirmation of positive ANA by more specific serologic tests. ANA (nuclear reactivity) positive patterns reported include centromere, homogeneous, nuclear dots, nucleolar, or speckled. ANA (cytoplasmic reactivity) positive patterns reported include reticular/AMA, discrete/GW body-like, polar/golgi-like, cytoplasmic speckled or rods and rings. All positive patterns are reported to endpoint titers (1:2560). Reported patterns may help guide differential diagnosis, although they may not be specific for individual antibodies or diseases. Mitotic staining patterns not reported. Negative results do not necessarily rule out SARD.

Compliance Category

FDA

Note

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

View Hotline History

 

Hotline History

Date of Change
Test Name Change
Methodology
Performance/Reported Schedule
Specimen Requirements
Reference Interval
Interpretive Data
Note
CPT Code
Component Change
Other Interface Change
New Test
Inactive
05/20/2024
X
X
N/A

CPT Codes

86039

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Components

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

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