ELF scores in the higher range (Table) are associated with higher risk of disease progression, defined as development of cirrhosis or liver-related events; scores in the lower range (Table) are associated with lower risk (Table).
Test Code: 10350
The Enhanced Liver Fibrosis (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 nonalcoholic steatohepatitis (NASH), to assess the likelihood of progression to cirrhosis and liver-related clinical events.”1
The ELF score is based on the combined quantitative measurements of 3 direct markers of hepatic fibrosis: hyaluronic acid (HA), amino-terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of matrix metalloproteinase 1 (TIMP-1).
Together, these assays measure qualitative and quantitative extracellular matrix (ECM) changes. The ECM refers to a set of macromolecules that comprise the extracellular scaffolding of the liver. Some ECM markers reflect fibrogenesis and others reflect fibrosis regression, allowing for a dynamic evaluation of ECM activity.
ELF scores in the higher range (Table) are associated with higher risk of disease progression, defined as development of cirrhosis or liver-related events; scores in the lower range (Table) are associated with lower risk (Table).
The package insert states the following: “In the Mid group, the risk of disease progression is similar to the pre-test risk. Pre-test risk refers to the likelihood of disease progression in the overall intended use population without considering the ELF score.” “Results should always be interpreted in conjunction with the patient’s medical history, clinical presentation, and other findings.”
ELF scores ≥7.7 may suggest the need for further specialized assessment when accompanied by other measurements indicating the presence of liver disease. The AACE 2022 NAFLD guideline for primary care and endocrinology (co-sponsored by AASLD) recommends that the following persons should be referred to a gastroenterologist or hepatologist for further assessment: (1) those with persistently elevated alanine transaminase (ALT) or aspartate aminotransferase (AST) levels and (2) those with hepatic steatosis on imaging and indeterminate or high risk based on imaging or blood tests, such as ELF score ≥7.7.2
Yes, the ELF test is supported by guidance from the following medical societies:
References
This FAQ is provided for informational purposes only and is not intended as medical advice. A physician’s test selection and interpretation, diagnosis, and patient management decisions should be based on the physician’s education, clinical expertise, and assessment of the patient.
Document FAQS.296 Version: 0
Version 0 effective 09/22/2023 to present