ELF test (Enhanced Liver Fibrosis)
Topic Status Complete
The Enhanced Liver Fibrosis test for diagnosing advanced fibrosis in metabolic dysfunction-associated steatotic liver disease.
Outcome of the appraisal
The evidence supports the routine adoption of a change to the Enhanced Liver Fibrosis (ELF) test score cut-off from 10.51 to 9.8 to diagnose advanced fibrosis (AF) in people with metabolic dysfunction-associated steatotic liver disease (MASLD) in any healthcare setting.
Evidence for use of a two-step pathway using the Fibrosis-4 (FIB-4) index, followed by an ELF test for people with an indeterminate FIB-4 score in primary care, is promising, but insufficient to support routine adoption.
Evidence exists for the diagnostic accuracy of the ELF test at a cut-off of 9.8 to diagnose AF in people with MASLD. Use of a two-step pathway may reduce unnecessary referrals to secondary care.
Health economic assessment estimates that reducing the ELF test cut-off from 10.51 to 9.8 is likely to be cost effective, with an incremental cost-effectiveness ratio of £14,842 per quality-adjusted life year gained. Cost effectiveness remained in a scenario reducing the ELF test cut-off in a two-step pathway following an indeterminate FIB-4.
Why was this topic appraised?
MASLD is a key driver for a global increase in liver disease, causing liver fibrosis. In early stages, liver fibrosis can be reversed but it is often asymptomatic until end-stage liver disease has developed. Advanced liver fibrosis (AF) represents a point where damage can still be halted. Liver fibrosis is diagnosed using liver biopsy, but this is invasive and expensive. The National Institute of Health and Care Excellence (NICE) suggests that people with MASLD are offered testing for AF in primary care using the non-invasive ELF test with a cut-off of 10.51 to diagnose AF [NG49]. The manufacturers of ELF recommend a reduction in the cut-off to 9.8 and proposed that use of a two-step diagnostic pathway to diagnose AF in people with MASLD in primary care may reduce unnecessary referrals to hepatology. The two-step pathway involves calculating the FIB-4 index as a first line test and using the ELF test as second line for people with an indeterminate FIB-4.
The topic was submitted by a commercial manufacturer. ELF is a trademark of Siemens Healthcare Diagnostics.
Plain language summary
The liver is a large organ located in the upper abdomen. The liver cleanses the blood and aids in digestion. Liver fibrosis occurs when the healthy tissue of a liver becomes scarred and cannot work as well. Fibrosis is the first stage of liver scarring. Some fibrosis can be reversible. Advanced liver fibrosis can result in liver failure and often requires a liver transplant. Liver fibrosis can be the result of drinking alcohol or it can be caused by inflammation due to excess fat cells.
The enhanced liver fibrosis (ELF) test is a blood test that gives a score to reflect the severity of liver fibrosis. The test has the potential to identify people at high risk of advanced liver fibrosis earlier than the current standard of care. This may help better determine what care a person needs and may lead to a reduction in unnecessary referrals to specialists and in the number of unnecessary liver biopsies.
Health Technology Wales looked for evidence on the ELF test for people considered at intermediate risk of advanced liver fibrosis. There is evidence for adequate diagnostic accuracy of the ELF test within certain parameters.
Topic Exploration Report
TER506 02.2024
Evidence Appraisal Review
EAR061 10.20224
Guidance
GUI061 10.2024
Health Technology Wales Partners
