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.
Table showing ELF Score Ranges and Risk of Disease Progression.
Click the table to open up a larger image
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:
- American Diabetes Association (ADA)
In the updated 2023 Standards of Diabetes Care, Recommendation 4.12 states the following:
“Adults with type 2 diabetes or prediabetes with an indeterminate or high fibrosis-4 index should have additional risk stratification by liver stiffness measurement with transient elastography, or the blood biomarker enhanced liver fibrosis.”3 - American Association for the Study of Liver Diseases (AASLD)
In the 2023 NAFLD practice guidance, Figure 2 comments state the following:
“In patients with FIB4 ≥1.3, a secondary assessment should be done [preferentially vibration-controlled elastography (VCTE) or Enhanced Liver Fibrosis (ELF) initially] or the patient referred for further risk stratification (if being seen in a nongastroenterology/hepatology setting).”4 - American Association of Clinical Endocrinology (AACE)
In the 2022 NAFLD clinical practice guideline (co-sponsored by AASLD), Recommendation 2.2.2 states the following:
“Clinicians should consider persons belonging to the “high-risk” groups (as defined under R2.1.1) who have an indeterminate or high FIB-4 score for further workup with an LSM (transient elastography) or ELF test, as available.”2 - American Gastroenterological Association (AGA):
In the 2022 clinical practice update on NAFLD in lean individuals, advice includes the following:
“ELF test may be used as a confirmatory prognostic test in patients with lean NAFLD until further data are available.”5
References
- Enhanced Liver Fibrosis (ELF™). Package insert. Siemens Healthcare Diagnostics Inc; 2022.
- Cusi K, Isaacs S, Barb D, et al. American Association of Clinical Endocrinology Clinical Practice Guideline for the Diagnosis and Management of Nonalcoholic Fatty Liver Disease in Primary Care and Endocrinology Clinical Settings: Co-Sponsored by the American Association for the Study of Liver Diseases (AASLD). Endocr Pract. 2022;28(5):528-562. doi:10.1016/j.eprac.2022.03.010
- ElSayed NA, Aleppo G, Aroda VR, et al. 4. Comprehensive Medical Evaluation and Assessment of Comorbidities: Standards of Care in Diabetes-2023 [published update appears in Diabetes Care. 2023;46(9):1718–1720]. Diabetes Care. 2023;46(Suppl 1):S49-S67. doi:10.2337/dc23-S004
- Rinella ME, Neuschwander-Tetri BA, Siddiqui MS, et al. AASLD Practice Guidance on the clinical assessment and management of nonalcoholic fatty liver disease. Hepatology. 2023;77(5):1797-1835. doi:10.1097/HEP.0000000000000323
- Long MT, Noureddin M, Lim JK. AGA Clinical Practice Update: Diagnosis and Management of Nonalcoholic Fatty Liver Disease in Lean Individuals: Expert Review. Gastroenterology. 2022;163(3):764-774.e1. doi:10.1053/j.gastro.2022.06.023
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.
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