DIAGNOSTIC TEST 020

ANA (HEp-2)

Diagnostic test for ANA (HEp-2). For suspicion of collagenosis diseases, systemic lupus erythematosus (SLE), scleroderma (SSc), mixed connective tissue disease (MCTD), primary Sjögren’s syndrome (SS), chronic active hepatitis (AIH), hypergammaglobulinemic purpura, juvenile rheumatoid arthritis, and drug-induced lupus.

Indication

Suspicion of collagenosis diseases, systemic lupus erythematosus(SLE), scleroderma(SSc), mixed connective tissue disease(MCTD), primary Sjögren’s syndrome(SS), chronic active hepatitis(AIH), hypergammaglobulinemic purpura, juvenile rheumatoid arthritis, drug-induced lupus.

Sample material

Serum

  • Minim. volume: 0,5 mL

Transport

Within Sweden

  • room temperature

International

  • cold

Method

Indirect immunofluorescence (IIF) on HEp-2 cells

Reference interval

  • <1:320 negative (screening dilution)

Result

Results are reported as negative or positive with a fluorescence intensity.

Interpretation

  • ANA with a homogeneous pattern is associated with several rheumatic diseases and autoimmune liver disease.

    Positive ANA is also found in approximately 5% of a healthy population. Samples with homogeneous ANA will be further analyzed for ANA-specificities (anti-dsDNA, anti-Sm, anti-nRNP, anti-SSA, anti-SSB, anti-Scl-70, anti-Jo1, anti-Ro 52, and anti-histones).
  • ANA with a speckled pattern is associated with several rheumatic diseases and autoimmune liver disease.

    Approximately 5% of a healthy population's normal sera show weak unspecific patterns. Samples with speckled ANA will be further analyzed for ANA-specificities (anti-dsDNA, anti-Sm, anti-nRNP, anti-SSA, anti-SSB, anti-Scl-70, anti-Jo1, and anti-Ro 52).
  • ANA with nucleolar pattern is primarily a marker of systemic sclerosis of diffuse type, but weak positive findings can also be seen in other conditions.

    If clinical suspicion of systemic sclerosis remains, can further analysis of scleroderma-associated autoantibody specificities be of value.
  • ANA with centromere pattern is primarily a marker for systemic sclerosis of limited type but is also seen in other rheumatic system diseases and primary biliary cholangitis (PBC).

  • ANA with specificity for PCNA

    is an unusual subtype of ANA but is regarded to have high specificity for SLE.
  • ANA with a nuclear dots pattern, further analysis of antibodies associated with primary biliary cholangitis (PBC) is recommended.

    Cholestatic liver tests?
  • ANA with a nuclear membrane pattern, further analysis of autoantibodies associated with primary biliary cholangitis (PBC) is recommended.

    Cholestatic liver tests?
  • Cytoplasmic reaction is detected and indicates the presence of antibodies against mitochondria.

    Cholestatic liver tests? Further analysis of autoantibodies associated with primary biliary cholangitis (PBC) is performed upon request. Please contact the lab for more information.
  • Cytoplasmic reaction detected and may be consistent with the presence of autoantibodies associated with dermatitis/polymyositis or interstitial lung disease.

    Further analysis is performed upon request, please contact the lab for more information.

References

  • Damoiseaux J et al. Auto Immun Highlights. 2016. International consensus on ANA patterns (ICAP): the bumpy road towards a consensus on reporting ANA results. PMID: 26831867
  • Damoiseaux J et al. Ann Rheum Dis. 2019. Clinical relevance of HEp-2 indirect immunofluorescent patterns: the International Consensus on ANA patterns (ICAP) perspective. PMID: 30862649
  • Hennes EM et al. Hepatology. 2008. Simplified criteria for the diagnosis of autoimmune hepatitis. PMID: 18537184
  • Chan EKL et al. LEC; ICAP Committee. The International Consensus on ANA Patterns (ICAP) in 2021-The 6th Workshop and Current Perspectives. J Appl Lab Med. 2022 Jan 5;7(1):322-330. PMID: 34996073.
  • Bonroy C et al. Clin Chem Lab Med. 2023 Detection of antinuclear antibodies: recommendations from EFLM, EASI and ICAP. Clin Chem Lab Med. 2023 PMID: 36989417.

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How to order

This test is available worldwide for hospitals, clinics, and physicians.

  1. Print and complete the request form

    Download the request form. Clearly state the name and phone number of the referring hospital, clinic, or physician.
  2. Prepare your samples

    Serum: At least 0.5 mL serum (plain serum tubes without additives).
  3. Send samples and request form

    Within Sweden
    Samples can be sent at room temperature to:
    Envelopes and smaller boxes:
    Wieslab AB, Box 50117, 20211 Malmö, Sweden

    Larger boxes and frozen samples:
    Wieslab AB, Lundavägen 151, 21224 Malmö, Sweden

    International
    Samples can be sent at room temperature to:
    Wieslab AB, Lundavägen 151, 21224 Malmö, Sweden

Read our sampling instructions for more information

Last updated: 2025-08-18