Enhanced Liver Fibrosis (ELF™) Test

Setting a new standard for liver fibrosis assessment.

"ELF markers can help diagnose patients with mild-to-moderate liver fibrosis (usually asymptomatic), allowing clinicians to intervene before significant damage occurs." Professor William Rosenberg, MD
Centre for Hepatology University
College London

What is Liver Fibrosis?

Liver fibrosis is the excessive accumulation of extracellular matrix proteins (e.g. collagen) in the liver, and occurs in chronic liver disease.

  • Main causes of liver fibrosis include hepatitis (HBV and HCV) infection, alcohol abuse, and non-alcoholic liver disease (NAFLD) that can result in non-alcoholic steatohepatitis (NASH).1
  • Advanced liver fibrosis can result in cirrhosis, liver failure, and portal hypertension – serious conditions that may require liver transplantation as an intervention.

Simplify liver fibrosis diagnosis with a blood test
Liver biopsy has been considered the “standard of care” to diagnose liver fibrosis2 however; a serum biomarker can simplify liver fibrosis diagnosis, and provide an answer without an invasive surgical procedure. Siemens Healthineers has developed the Enhanced Liver Fibrosis (ELF™) Test to aid clinicians in the diagnosis of liver fibrosis in patients with chronic liver disease.


What is the ELF Test?

The Enhanced Liver Fibrosis (ELF™) Test* is a routine blood test that provides an ELF Score that delivers information on liver fibrosis severity. The ELF Score is determined by combining in an algorithm, quantitative measurements of the following by-products of the fibrotic process.

  • Hyaluronic acid (HA)
  • Amino-terminal propeptide of type III procollagen (PIIINP)
  • Tissue inhibitor of metalloproteinase 1 (TIMP-1)

The use of the ELF test has been established in viral hepatitis,3-5 NAFLD,3,6,7 and alcoholic patient groups.3 The ELF test has been shown to be at least as accurate as biopsy at predicting liver disease-related outcomes.8,9

Siemens Healthineers ELF Test Benefits

  • Offers a minimally-invasive blood test with results that correlate to the level of liver fibrosis severity assessed by liver biopsy.
  • Provides results quickly, allowing for proper clinical treatment of patients at risk for severe liver disease.
  • Delivers a test included in evidence-based guidelines recommended by National Institute for Health and Care Excellence (NICE)1 to test for and monitor advanced liver fibrosis in people diagnosed with Non-Alcoholic Fatty Liver Disease (NAFLD).

National Institute for Health and Care Excellence (NICE) NAFLD guidelines

The European Association for the Study of the Liver (EASL) approves use of non-invasive methods instead of liver biopsy to assess the degree of liver fibrosis in hepatitis C patients.9 The National Institute for Health and Care Excellence (NICE) NAFLD guidelines10 recommend the use of the ELF Test to test for and monitor advanced liver fibrosis in people diagnosed with NAFLD.

  • Consider using the ELF test in people who have been diagnosed with NAFLD to test for advanced liver fibrosis
  • Offer retesting for advanced liver fibrosis for people with an ELF score less than 10.51 every 3 years to adults and every 2 years to children and young people
  • Consider using the ELF test for retesting people with advanced liver fibrosis

Link to NICE Guidelines: NICE Guidelines: Non-Alcoholic Fatty Liver Disease: assessment and management.


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* Not available for sale in the U.S. Product availability may vary from country to country and is subject to varying regulatory requirements.

References
1. Bataller R., and Brenner, David A., J Clin Invest. 2005 Feb 1; 115(2): 209-218.
2. Afdhal, NH, Nunes D., Am J. Gastroenterol. 2004; 99:1160-1174.
3. Rosenberg et al., (2004) “Serum Markers Detect the Presence of Liver Fibrosis: A Cohort Study” Gastroenterology 127:1704–1713.
4. Parkes et al., (2010) “Enhanced Liver Fibrosis Test Can Predict Clinical Outcome in Patients with Chronic Liver Disease,” Gut 2010;59:1245–1251.
5. Cobbold et al., (2010) “Optimal Combinations of Ultrasound-based and Serum Markers of Disease Severity in Patients with Chronic Hepatitis C,” Journal of Viral Hepatitis 17:537–545.

6. Guha et al., (2008) “Non-invasive Markers of Fibrosis in Nonalcoholic Fatty Liver Disease: Validating the European Liver Fibrosis Panel and Exploring Simple Markers,” Hepatology 47:455–460.
7. Nobili et al., (2009) “Performance of ELF Serum Markers in Predicting Fibrosis Stage in Pediatric Non-Alcoholic Fatty Liver Disease,” Gastroenterology 136:160–167.
8. Pinzani, (2010) “The ELF Panel: A New Crystal Ball in Hepatology?” Gut 59:1165–1167.
9. European Association for the Study of the Liver (EASL) “Clinical Practice Guidelines: Management of hepatitis C virus infection,” Berlin 2011.
10. NICE guideline “Non-alcoholic fatty liver disease (NAFLD): assessment and management.” Published 6 July 2016.