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Autoimmune liver disease

Gold Standard IFA Technology
Rodent tissue combination (liver, kidney, stomach) endorsed by AASLD & EASL guidelines2

Proprietary BIOCHIP Technology
Enables screening and confirmation of target antigens in a single miniature field

8-Parameter Profile Available
Multiple Antigen Detection or Multiplex Testing detecting AMA M2, M2-3E, Sp100, PML, gp210, LKM-1, LC-1, SLA/LP

Reliable Automation Solutions
ELISA, IFA, and EUROLINE options for flexible workflow integration

Background

Autoimmune liver diseases (ALDs) are characterized by autoantibody production against hepatic and biliary cells, potentially progressing to cirrhosis or liver failure without intervention. Each ALD is associated with characteristic autoantibody profiles, and their identification facilitates differential diagnosis among these conditions.1 Euroimmun offers solutions enabling the detection of ALD-specific autoantibodies for conditions such as:

  • Autoimmune hepatitis (AIH)
  • Primary biliary cholangitis (PBC)
  • Primary sclerosing cholangitis (PSC)

Diagnostics

Diagnosis of ALDs relies on a combination of clinical assessment, liver function tests, histology, imaging, and serological detection of disease-specific autoantibodies.1 AIH is associated with antibodies against cell nuclei (ANA), smooth muscle (ASMA), soluble liver antigen/liver-pancreas antigen (SLA/LP), liver cytosolic antigen type 1 (LC-1), and anti-liver kidney microsome (anti-LKM1).2,3 PBC is characterized by ANA and anti-mitochondrial antibodies (AMA),4,5 while PSC typically exhibits perinuclear anti-neutrophil cytoplasmic antibodies (p-ANCA).6,7 The American Association for the Study of Liver Diseases (AASLD) and European Association for the Study of the Liver (EASL) endorse serological testing as a first-line diagnostic tool for suspected autoimmune liver diseases, recommending indirect immunofluorescence assays (IFA) on a combination of rodent tissues as the gold-standard.2-5

Euroimmun’s BIOCHIP technology allows the combination of substrates such as rat liver, kidney, and stomach to enhance recognition of autoantibody-specific fluorescent patterns.

Additionally, Euroimmun provides a range of solid-phase assays, including ELISA and EUROLINE immunoblots, covering autoantibodies relevant to AIH, PBC, and PSC. These monospecific assays detect antibodies against targets such as Sp100, gp210, PML, AMA, F-actin, LC-1, LKM-1, and SLA/LP.

References

  1. Sebode M, Weiler-Normann C, Liwinski T, Schramm C. Autoantibodies in autoimmune liver disease–clinical and diagnostic relevance. Front Immunol. 2018;9:609. doi: 3389/fimmu.2018.00609.
  2. Mack CL, Adams D, Assis DN, et al. Diagnosis and management of autoimmune hepatitis in adults and children: 2019 practice guidance and guidelines from the American Association for the Study of Liver Diseases. Hepatology. 2020;72(2):671–722. doi: 1002/hep.31065.
  3. Dalekos G, Gatselis N, Drenth JP, et al. EASL Clinical Practice Guidelines on the management of autoimmune hepatitis. Journal of Hepatology. 2025;83(2):453-501. doi:https://doi.org/10.1016/j.jhep.2025.03.017.
  4. Lindor KD, Bowlus CL, Boyer J, Levy C, Mayo M. Primary biliary cholangitis: 2018 Practice Guidance from the American Association for the Study of Liver Diseases. Hepatology. 2019;69(1):394–419. doi: 10.1002/hep.30145.
  5. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. Journal of Hepatology. 2017;67(1):145–172. doi: 10.1016/j.jhep.2017.03.022.
  6. Bowlus CL, Arrivé L, Bergquist A, et al. AASLD practice guidance on primary sclerosing cholangitis and cholangiocarcinoma. Hepatology. 2023;77(2):659–702. doi: 10.1002/hep.32771.
  7. Chazouilleres O, Beuers U, Bergquist A, et al. EASL Clinical Practice Guidelines on sclerosing cholangitis. Journal of Hepatology. 2022;77(3). doi:https://doi.org/10.1016/j.jhep.2022.05.011

Autoimmune liver disease products

For in vitro diagnostic use.

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