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.

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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

  • Homogeneous pattern is associated to several rheumatic systemic diseases and autoimmune liver disease. Approximately 5% of the healthy population show weak unspecific reaction. Homogeneous ANA is automatically complemented with analysis of antibodies againts dsDNA, Sm, nRNP, SSA, SSB, Scl-70, Jo1, Ro 52 and histones.
  • Speckled pattern is associated with several rheumatic systemic diseases and autoimmune liver disease. Approximately 5% of the healthy population show weak unspecific reaction. Speckled ANA is automatically complemented with analysis of antibodies againts dsDNA, Sm, nRNP, SSA, SSB, Scl-70, Jo1, and Ro52.
  • Nucleolar pattern is a marker for systemic sclerosis of diffuse type, but weak positive findings can also be seen in several other conditions. In case of clinical suspicion of systemic sclerosis, complementary analysis of scleroderma associated autoantibodies may be of value.
  • 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).
  • Anti-PCNA (Prolifererative cell nuclear antigen) is an unusual subtype of ANA but is regarded to have high specificity for SLE.
  • Nuclear dots pattern. In these cases, further analysis of antibodies associated with primary biliary cholangitis (PBC) is recommended.
  • Nuclear membrane pattern. In these cases, further analysis of autoantibodies associated with primary biliary cholangitis (PBC) is recommended.
  • Cytoplasmic reaction indicating the presence of antibodies against mitochondria. In these cases, further analysis of autoantibodies associated with primary biliary cholangitis (PBC) is recommended.
  • Cytoplasmic reaction. Further testing is recommended if there is clinical suspicion of inflammatory myositis and/or interstitial lung disease.

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. If you are a new customer, please also include a completed customer information form.

  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
    Send samples cold to:
    Wieslab AB, Lundavägen 151, 21224 Malmö, Sweden

Last updated: 2026-07-09