Test Id : ELF
Enhanced Liver Fibrosis (ELF), Serum
Useful For
Suggests clinical disorders or settings where the test may be helpful
As a prognostic marker in conjunction with other laboratory findings and clinical assessments to assess the likelihood of progression to cirrhosis and liver-related clinical events in patients with advanced fibrosis (F3 or F4) due to metabolic dysfunction-associated steatohepatitis (MASH)
Method Name
A short description of the method used to perform the test
Direct Chemiluminescent Immunoassay
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Liver Fibrosis
ELF
Hepatitis
Hepatic Inflammation
Testing Alias
Specimen Type
Describes the specimen type validated for testing
Serum
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Patient Preparation: For 12 hours before specimen collection, patient should not take multivitamins or dietary supplements (eg, hair, skin, and nail supplements) containing biotin (vitamin B7).
Supplies: Sarstedt Aliquot Tube, 5 mL (T914)
Collection Container/Tube:
Preferred: Serum gel
Acceptable: Red top
Submission Container/Tube: Plastic vial
Specimen Volume: 1 mL Serum
Collection Instructions: Within 2 hours of collection, centrifuge and aliquot serum into a plastic vial. Specimens that have not been aliquoted will be rejected.
Forms
If not ordering electronically, complete, print, and send Gastroenterology and Hepatology Test Request (T728) with the specimen.
Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.
Serum: 0.5 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | Reject |
| Gross lipemia | OK |
| Gross icterus | OK |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 7 days | |
| Ambient | 48 hours | ||
| Frozen | 365 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
As a prognostic marker in conjunction with other laboratory findings and clinical assessments to assess the likelihood of progression to cirrhosis and liver-related clinical events in patients with advanced fibrosis (F3 or F4) due to metabolic dysfunction-associated steatohepatitis (MASH)
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Chronic liver disease is a major cause of morbidity and mortality throughout the world. Typical disease etiologies that lead to chronic liver disease include metabolic dysfunction-associated steatotic liver disease (MASLD), alcoholic liver disease, primary sclerosing cholangitis, primary biliary cholangitis, and viral hepatitis due to chronic infection with hepatitis B virus and hepatitis C virus.
Metabolic dysfunction-associated steatotic liver disease is now the most common underlying cause of chronic liver disease.
Within MASLD, metabolic dysfunction-associated steatohepatitis (MASH) is the more severe form, characterized by hepatic steatosis (fatty infiltration of the liver), inflammation, and hepatocyte injury (ballooning).
The clinical course of chronic liver disease is highly variable, but the typical progression involves the advancement of fibrosis, leading to cirrhosis followed by either decompensation or hepatocellular carcinoma, and ultimately liver transplantation or death.
Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
| ELF score | Risk of disease progression |
| > or =9.20 | Diagnostic cut-off for clinically significant fibrosis (fibrosis stage 2 or greater) |
| > or =11.30 | Prognostic cut-off for higher risk of progression to liver-related clinical events |
Interpretation
Provides information to assist in interpretation of the test results
A prognostic risk assessment using the enhanced liver fibrosis (ELF) score, in conjunction with other laboratory findings and clinical assessments, may be useful in determining which patients could benefit from additional examinations, increased monitoring, and potential lifestyle changes and treatment interventions.
The ELF score quantifies analytes that are components of the extracellular matrix (ECM), which directly contribute to liver fibrosis. Hyaluronic acid, a glycosaminoglycan produced by hepatic stellate cells, is an essential component within the connective matrix. Amino-terminal propeptide of type III procollagen (PIIINP), produced by fibroblasts in the liver, is a marker of fibrogenesis and inflammation. Tissue inhibitor of matrix metalloproteinase 1 is a circulating inhibitor of matrix metalloproteinase enzymes that can inhibit fibrolysis and fibrosis repair. Together, these analytes reflect qualitative and quantitative changes in the ECM associated with progression of liver disease.
The ELF score is a prognostic marker for patients with advanced fibrosis (F3 or F4) due to metabolic dysfunction-associated steatohepatitis. ELF is used to assess the risk of progression to cirrhosis and future liver-related clinical events up to 3.9 years following baseline ELF score.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Biotin concentrations greater than 150 ng/L falsely decreases propeptide of type iii procollagen and enhanced liver fibrosis score.
In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies [HAMA] or heterophile antibodies), which may cause interference in some immunoassays. Caution should be used in interpretation of results, and the laboratory should be alerted if the result does not correlate with the clinical presentation.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
1. 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
2. Palladino A, Gee M, Shalhoub V, Kiaei D. Analytical performance of the Enhanced Liver Fibrosis (ELF) Test on the Atellica IM Analyzer. Clin Chim Acta. 2023;548:117461. doi:10.1016/j.cca.2023.117461
3. Sanyal AJ, Shankar SS, Yates KP, et al. Diagnostic performance of circulating biomarkers for non-alcoholic steatohepatitis. Nat Med. 2023;29(10):2656-2664. doi:10.1038/s41591-023-02539-6
Method Description
Describes how the test is performed and provides a method-specific reference
The enhanced liver fibrosis (ELF) score uses the measured concentrations of hyaluronic acid (HA), amino-terminal pro-peptide of type III procollagen (PIIINP), and tissue inhibitor of matrix metalloproteinase 1 (TIMP-1), abbreviated as CHA, CPIINP, and CTIMP-1, respectively, in the equation below. Testing is performed using the fully automated ADVIA Centaur instrument with the ADVIA Centaur HA, ADVIA Centaur PIIINP, and ADVIA Centaur TIMP-1 reagents. These reagents are based on 2-site sandwich assay methodology and direct chemiluminescent technology. The concentrations of HA, PIIINP, and TIMP-1 are not reported individually.(Package insert: Advia Centaur XPT ELF. Siemens Healthcare Diagnostics Inc.; 11205858_EN Rev. 02, 10/2022)
The ELF score is calculated from the concentration of the 3 measured analytes using the following equation:
ELF (score) = 2.278 + 0.851 ln(CHA) + 0.751 ln(CPIIINP) + 0.394 ln(CTIMP-1)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.
Monday through Friday
Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.
- Authorized users can sign in to Test Prices for detailed fee information.
- Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
- Prospective clients should contact their account representative. For assistance, contact Customer Service.
Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.
This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.
CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
CPT codes are provided by the performing laboratory.
CPT codes are provided by the performing laboratory.
81517
LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.
| Test Id | Test Order Name | Order LOINC Value |
|---|---|---|
| ELF | ELF (Enhanced Liver Fibrosis), S | 88055-9 |
| Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
|---|---|---|
| ELFSC | ELF Score | 88055-9 |