Assess the Risk of NAFLD/NASH Progression and Liver-Related Events with a Simple Blood Test
Clinical Benefits of The Enhanced Liver Fibrosis (ELF™) Test
The Enhanced Liver Fibrosis test is a non-invasive blood test that measures three direct markers of fibrosis. Direct assessment of fibrosis has proven valuable for identifying patients at risk of progressing to cirrhosis and/or liver-related events.
The most widely studied direct marker is the ELF Test which can assess active, dynamic fibrosis rather than the damage it has caused. This allows the ELF Test to be used as a prognostic marker to identify the patients most at risk of progression to cirrhosis and LREs in patients with chronic liver disease.
Why choose the ELF Test?
Characteristics of an Ideal Non-invasive Liver Fibrosis Test
1. Day J, et al. J Appl Lab Med. 2019 Mar; 3:815-26.
2. Parkes J, et al. Gut. 2010; 59:1245-51.
3. Irvine KM, et al. Liver Int. 2016; 36:370-7.
4. Rosenburg WM, et al. Gastroenterology. 2004; 127:1704-13
5. Nobili, et al. Gastroenterology. 2009; 136:160-7
6. Srivastava A, et al. J Hepatol. 2019; Apr 6: 50168-8278{19}30227-2. doi: 10.1016/j.hep.2019.03.033.
Clinical Benefits of ELF
A simple blood test. Any patient. Any provider.
Blood-based tests can readily support high-volume testing, do not require patient access to specialized imaging equipment or highly trained operators, and generally have lower incidence rates of failure and unreliable results reported for imaging modalities.1,2
- 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.2,3
- Improve patient care by identifying NAFLD patients and stratifying those at risk of progressing to cirrhosis and LREs.4
- Enhance prognostic patient management with a test that has been shown to outperform biopsy for the risk assessment of progression to cirrhosis and LREs.4
Reduce Unnecessary Referrals and Save Healthcare Costs
To reduce the burden of unnecessary referrals and improve detection of advanced liver disease, a “NAFLD pathway” was developed comprised of testing first with FIB-4 and reflexing indeterminate results to ELF. After 2 years the pathway data was compared to the Standard of Care.5
Literature Compendium Volume 2:
ELF Test in NAFLD/NASH
Diagnostic Accuracy and Cost-effectiveness
ELF Ranks First in Cost-Effectiveness Analysis
The population considered for analysis were persons with NAFLD who were suspected of having developed NASH with fibrosis or cirrhosis. This analysis found that, given a retesting frequency of 3 years, ELF was the highest ranking of the 13 tests compared at a cost-effectiveness threshold of £20,000 per QALY gained, followed by Siemens Healthineers ARFI.
The Guideline Development Group concluded that ELF is both the most cost-effective and the most appropriate test for advanced fibrosis in adults with NAFLD and should be offered to people with NAFLD.6
Advanced fibrosis test ranking based on diagnostic accuracy and cost-effectiveness
Cost-effectiveness = the value of the net monetary benefit (NMB) attributed to every test.
The comparator with the highest NMB is the most cost-effective option at the specified £20,000 per extra QALY threshold.
Clinical Guidelines
Multiple Clinical Guidelines Recommend Use of Non-invasive Markers
Chronic Liver Disease Foundation (CLDF)
"To date, the ELF score demonstrates good correlations with progression of fibrosis in a number of chronic liver diseases."
Younossi ZM, et al. Am J Gastro. 2020;00:1–9. https://doi.org/10.14309/ajg.0000000000001054
The National Institute for Health and Care Excellence (NICE)
"Consider using the Enhanced Liver Fibrosis (ELF) Test in people who have been diagnosed with NAFLD to test for advanced fibrosis.”
National Guideline Centre; Royal College of Physicians. NICE guideline NG492016. ISBN 978-1-4731-1996-3.
European Association for the Study of the Liver (EASL)
“Surrogate markers of fibrosis (NFS, FIB-4, ELF Test or FibroTest) should be calculated for every NAFLD patient, in order to rule out significant fibrosis (≥F2).”
EASL–EASD–EASO. J Hepatol. 2016;64:1388–1402.
American Association for the Study of Liver Diseases (AASLD)
“NFS or FIB-4 index are clinically useful tools for identifying NAFLD patients with higher likelihood of having bridging fibrosis (stage 3) or cirrhosis (stage 4).”
Chalasani N, et al. Hepatology. 2018;67:328–357.
American Diabetes Association (ADA)
"Noninvasive tests, such as elastography or fibrosis biomarkers, may be used to assess risk of fibrosis, but referral to a liver specialist and liver biopsy may be required for definitive diagnosis.”
American Diabetes Association. Diabetes Care. 2019;42(suppl1):S1–S193.
British Society of Gastroenterology (BSG)
"Patients with intermediate risk should undergo second-line non-invasive testing either by additional tests like ELF test or FibroTest or by measuring liver stiffness.7,8 If advanced fibrosis is ruled out, patients can be treated as low risk and referred back to primary care.”
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Eddowes PJ, Sasso M, Allison M, et al. Accuracy of FibroScan Controlled Attenuation Parameter and Liver Stiffness Measurement in Assessing Steatosis and Fibrosis in Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology 2019;156:1717-30.
Vilar-Gomez E, Chalasani N. Non-invasive assessment of non-alcoholic fatty liver disease: Clinical prediction rules and blood-based biomarkers. J Hepatol 2018;68:305-15.