Clinical Benefits of The Enhanced Liver Fibrosis (ELF) Test
Assess the Risk of NAFLD/NASH Progression and Liver-related Events with a Simple Blood Test
The Enhanced Liver Fibrosis (ELF™) 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 Test1-6
Validated Across Multiple Settings
Applicability in Different Patients/Conditions
Economic Health Value
Add clinical value
Decrease unnecessary referrals
Simple blood test
Large installed base
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.7,8
- 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.10
- Enhance prognostic patient management with a test that has been shown to outperform biopsy for the risk assessment of progression to cirrhosis and LREs.10
ELF is featured in more than 200 peer-reviewed publications and has been evaluated in multiple forms of chronic liver disease
- Non-alcoholic fatty liver disease (NAFLD)
- Non-alcoholic steatohepatitis (NASH)
- Alcoholic liver disease (ALD)
- Primary sclerosing cholangitis (PSC)
- Primary biliary cirrhosis (PBC)
- Chronic HBV infection (CHB)
- Chronic HCV infection (CHC)
- Mixed chronic liver disease etiologies
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.6
Multiple NAFLD/NASH International Clinical Guidelines Recommend ELF
The ELF Test is included in multiple international clinical guidelines supporting ELF both as a diagnostic and prognostic marker in NAFLD/NASH.
American Association of Clinical Endocrinology (AACE)
"Clinicians should consider persons belonging to the 'high-risk' groups who have an indeterminate or high FIB-4 score for further workup with an LSM (transient elastography) or ELF test, as available."
American Gastroenterological Association (AGA)
“We concluded that the ELF Test may be used as a conﬁrmatory prognostic test in patients with lean NAFLD until further data are available.”
Long, M, et al. Gastroenterology. https://doi.org/10.1053/j.gastro.2022.06.023
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."
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
European AIDS Clinical Society (EACS)
"Whenever imaging tools are not available or feasible, serum biomarkers and scores (such as ELF) are an acceptable alternative for the diagnosis of NAFLD in PLWH."
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)."
French Association for the Study of the Liver (AFEF)
“A specialized blood marker (Fibrometer, Fibrotest, ELF) or a measurement of liver stiffness must be performed in second intention if a simple blood marker suggests the presence of an advanced chronic liver disease”
Boursier J, et al. AFEF. 2020
Korean Association for the Study of the Liver (KASL)
"When subjects are classified as intermediate risk by TE, FIB-4, or the NFS, additional tests such as M2BPGi, AsAGP, ELF, SWE, or MRE can be performed."
Kang H, et al. Clinical and Molecular Hepatology 2021;27:363-401
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.
Spanish Association for the Study of the Liver (AEEH)
"Patients in the gray zone could benefit from a second non-invasive method such as ELF or Owl-liver, which would allow defining which patients are at risk of advanced fibrosis."
Romero-Gómez M, et al. Gastroenterología y Hepatología. https://doi.org/10.1016/j.gastrohep.2022.04.001
Diagnostic Accuracy and Cost-effectiveness
ELF Ranks First in Analysis of Cost-effectiveness
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.16
Advanced fibrosis test ranking based on diagnostic accuracy and cost-effectiveness
Mean cost (£)
NMB (£) at £20,000/QALY
ELF Test at 10.51
ARFI at 4.24
MRE at 4.15
FibroTest at 0.47
NFS at 0.676
TE (M) at 7.8–7.9
APRI at 0.98-1
FIB-4 at 1.45
BARD at 2
AST/ALT at 0.8
TE (XL) at 5.7
No test—monitor all
Ferritin at 2x
No test—monitor nobody
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 quality-adjusted life year (QALY) threshold.
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The products/features (mentioned herein) are not commercially available in all countries. Their future availability cannot be guaranteed.
In the U.S., the ELF Test is indicated as a prognostic marker in conjunction with other laboratory findings and clinical assessments in patients with advanced fibrosis (F3 or F4) due to non-alcoholic steatohepatitis (NASH) to assess the likelihood of progression to cirrhosis and liver-related clinical events.