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HelpTest Code LAB5169 ELF (Enhanced Liver Fibrosis), S
Specimen Required
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.
Useful For
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
Direct Chemiluminescent Immunoassay.
Reporting Name
ELF (Enhanced Liver Fibrosis), S
Specimen Type
Seurm.
Specimen Stability Information
| Specimen Type |
Temperature | Time | Special Container |
|---|---|---|---|
| Serum | Refrigerated (preferred) | 7 days | |
| Ambient | 48 hours | ||
| Frozen | 365 days |
Specimen Minimum Volume
Serum: 0.5 mL
Reject Due To
| Gross hemolysis | Reject |
| Thawing | Cold OK,Warm reject |
| Gross lipemia | OK |
| Gross icterus | OK |
Clinical Information
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.
Interpretation
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.
Method Description
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)
Report Available
Same day/1 to 3 days.
Reference Values
| ELF Score | Risk of disease progression |
| ≥ 9.20 |
Diagnostic cut-off for clinically significant fibrosis (fibrosi stage 2 or greater) |
| ≥ 11.30 | Prognostic cut-off for higher risk of progression to liver-related clinical events |
Test Classification
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
81517
Resultables
| Result ID | Result Name | LOINC Value |
|---|---|---|
| ELFSC | ELF Score | 88055-9 |