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Test Code ELF Enhanced Liver Fibrosis (ELF), Serum


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

Serum

Specimen Minimum Volume

Serum: 0.5 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Refrigerated (preferred) 7 days
  Frozen  365 days
  Ambient  48 hours

Reject Due To

Gross hemolysis 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.

Reference Values

ELF score

Risk of disease progression

≥9.20

Diagnostic cut-off for clinically significant fibrosis (fibrosis stage 2 or greater)

≥11.30

Prognostic cut-off for higher risk of progression to liver-related clinical events

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.

 

Cautions

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.

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)

Day(s) Performed

Monday through Friday

Report Available

Same day/1 to 3 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ELF ELF (Enhanced Liver Fibrosis), S 88055-9

 

Result ID Test Result Name Result LOINC Value
ELFSC ELF Score 88055-9