Enhanced Liver Fibrosis (ELF™) Test
Non-alcoholic fatty liver disease (NAFLD) impacts over 1 billion globally and is projected to become the leading cause of liver-related mortality within 20 years.1 As new therapies become available, non-invasive testing is an important tool to help identify patients at risk of developing cirrhosis and liver-related clinical events (LREs).
NAFLD: A Global Epidemic
NAFLD is a condition in which excess fat is stored in the liver. The buildup of fat that is not caused by heavy alcohol use.
- There are two types of NAFLD: simple fatty liver (simple steatosis) and non-alcoholic steatohepatitis (NASH).
- Comorbidities such as obesity, and type 2 diabetes are associated with NAFLD.2
- NAFLD is predicted to be the leading indication for liver transplantation within a decade.3
Current Challenges in NAFLD Patients
- Differentiating NASH from simple steatosis (risk-stratification) and identifying NASH patients with advanced fibrosis.
- Despite being the gold standard for diagnosing liver fibrosis, liver biopsy is a painful and invasive procedure associated with inter- and intra-observer variability, and sampling error, which may make it impractical to use in every patient.4,5,6
- Currently, there is no available liver fibrosis test that is convenient, objective, reproducible, and widely accessible to all relevant healthcare practitioners.
The ELF Test
The ELF test* is a non-invasive blood test that measures three direct markers of fibrosis: hyaluronic acid (HA), procollagen III amino-terminal peptide (PIIINP), and tissue inhibitor of matrix metalloproteinase 1 (TIMP-1). The ELF test, in conjunction with other laboratory and clinical findings, can be used to assess the risk of progression to cirrhosis and LREs in patients with chronic liver disease.7
- Access non-invasive testing with a simple blood test available to all healthcare practitioners and patients, including those with type 2 diabetes mellitus and obesity.8,9
- Improve patient care by identifying NAFLD patients and stratifying those at risk of progressing to cirrhosis and LREs.7
- Enhance prognostic patient management with a test that has been shown to outperform biopsy for the risk assessment of progression to cirrhosis and LREs.7
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.10 The National Institute for Health and Care Excellence (NICE) NAFLD guidelines11 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.
* Not available for sale in the U.S. Product availability may vary from country to country and is subject to varying regulatory requirements.
1. Munteanu MA, Nagy GA, Mircea PA. Current Management of NAFLD. Clujul Med. 2016;89(1):19–23. doi:10.15386/cjmed-539.
2. Younossi ZM, et al. Hepatology. 2016;64:73–84.
3. Pais R, Barritt AS 4th, Calmus Y, et al. NAFLD and liver transplantation: Current burden and expected challenges. J Hepatol. 016;65(6):1245–1257. doi:10.1016/j.jhep.2016.07.033
4. Pavlides M, et al. Am J Clin Pathol. 2017;147:364–369.
5. Ratziu V, et al. Gastroenterology. 2005;128:1898–1906.
6. Arora A and Sharma P. J Clin Exp Hepatol. 2012;2:145–155.
7. Sanyal AJ, et a. Hepatology. 2019 Apr 16. doi: 10.1002/hep.30664. [Epub ahead of print].
8. Patel P, et al. Hepatol Commun. 2018;2:893–905.
9. Karlas T, et al. PLoS ONE. 2015;10(11):e0141649.
10. European Association for the Study of the Liver (EASL) “Clinical Practice Guidelines: Management of hepatitis C virus infection,” Berlin 2011.
11. NICE guideline “Non-alcoholic fatty liver disease (NAFLD): assessment and management.” Published 6 July 2016.