Laboratory Testing for Autoimmune Liver Diseases
Delivering the Confidence to Guide Decisions

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Liver diseases of various etiologies can lead to liver cirrhosis and the need for a liver transplant but are often characterized by unspecific symptoms, such as jaundice, chronic fatigue, or abdominal pain.1,2 Although rare, autoimmune liver diseases represent a major cause of liver cirrhosis, and their differential diagnosis from non-autoimmune liver diseases (such as viral hepatitis) enables the clinician to make informed treatment decisions and to improve a patient’s quality of life.1-5

Primary biliary cholangitis (PBC) and autoimmune hepatitis (AIH) are the most clinically important autoimmune liver diseases.1,2 PBC is characterized by a chronic inflammation of the small bile ducts and impaired bile formation that can lead to liver cirrhosis and the need of a liver transplant.2,4 In case of AIH, an inflammation of the hepatocytes can lead to liver failure.1,6

Recommendations for the differential diagnosis of PBC and AIH include:

  • Testing for anti-mitochondrial antibodies (AMA)/anti-M2 antibodies and anti-LKM-1 antibodies.1,2
  • Confirmatory testing of negative and positive immunofluorescence assay (IFA) results with high-quality solid phase tests to reduce false negative and false positive results.4,5,7

In case of anti-LKM-1 antibodies, the results of IFA and solid phase tests are considered interchangeable.1 

 

Why choose Thermo Fisher Scientific as your partner in autoimmune liver disease diagnostics?

 

Best-in-class testing to support the diagnosis of PBC

In a scientific study, the EliATM M2 test demonstrated a comparable sensitivity (100 percent) and a superior specificity (98 percent versus 77 percent) to IFA.8 The EliA M2 test enables you to detect AMA/anti-M2 antibodies with confidence, efficiently.

 

Best-in-class testing to support the diagnosis of AIH (Type 2)

In a comparative study, the EliA™ LKM-1 test demonstrated a higher sensitivity than IFA (72.8 percent versus 69.1 percent), at the stratified specificity of 94.8 percent, to support the diagnosis of AIH (type 2).The EliA LKM-1 test helps clinicians make an accurate diagnosis in this difficult to diagnose disease that can lead to cirrhosis and whose onset usually occurs in childhood and young adulthood.10  

 

Driving efficiency in rare autoimmune disease testing

EliA M2 and EliA LKM-1 tests benefit from the fully automated features on Phadia™ Laboratory Systems. Unlike IFA, laboratorians with standard training can run these tests as part of your Phadia Laboratory Systems workflow. EliA M2 and EliA LKM-1 tests can be performed from the same patient sample at the same time when there is a clinical suspicion of PBC and AIH. For rare tests such as these, the random-access functionality of the PhadiaTM 250 and the PhadiaTM 2500 and PhadiaTM 5000 instrument can help streamline workflows, further minimizing the impact on laboratory practice.  

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References
  1. European Association for the Study of the L. EASL Clinical Practice Guidelines: Autoimmune hepatitis. J Hepatol. 2015;63(4):971-1004.
  2. European Association for the Study of the Liver. Electronic address eee, European Association for the Study of the L. EASL Clinical Practice Guidelines: The diagnosis and management of patients with primary biliary cholangitis. J Hepatol. 2017;67(1):145-72.
  3. Poupon R. Primary biliary cirrhosis: a 2010 update. J Hepatol. 2010;52(5):745-58.
  4. Sebode M, Weiler-Normann C, Liwinski T, Schramm C. Autoantibodies in Autoimmune Liver Disease-Clinical and Diagnostic Relevance. Front Immunol. 2018;9:609.
  5. Muratori P, Lenzi M, Cassani F, Lalanne C, Muratori L. Diagnostic approach to autoimmune hepatitis. Expert Rev Clin Immunol. 2017;13(8):769-79.
  6. Francque S, Vonghia L, Ramon A, Michielsen P. Epidemiology and treatment of autoimmune hepatitis. Hepat Med. 2012;4:1-10.
  7. Reshetnyak VI. Primary biliary cirrhosis: Clinical and laboratory criteria for its diagnosis. World J Gastroenterol. 2015;21(25):7683-708.
  8. Alfano AM, Romito A, Marchese C, Battistini M, Crotti G, Ferrini A, et al. Diagnostic accuracy of two tests for determination of anti-m2 in the diagnosis of primary biliary cirrhosis: Is it possible to predict the course of the disease? Immunol Res. 2017;65(1):299-306.
  9. Scientfic TF. Internal study. Data in file.
  10. Czaja AJ. Diagnosis and Management of Autoimmune Hepatitis: Current Status and Future Directions. Gut Liver. 2016;10(2):177-203.