The Enhanced Liver Fibrosis (ELF) Test The first and only blood test authorized for use as a prognostic marker in patients with advanced fibrosis due to MASH.
The ELF® Test is a noninvasive test based on markers of active liver fibrosis, providing clinically meaningful insight into risk of disease progression[AT1] . Because fibrosis is the strongest predictor of liver-related outcomes and a key driver of MASLD/MASH* progression, tests measuring direct biomarkers of liver fibrosis can deliver critical value for patient management.1
Using a single serum sample on a fully automated immunoassay platform, the ELF Test enables objective, scalable testing that can help clinicians assess risk of disease progression in their MASH patients, support earlier intervention, and potentially improve patient care pathways and outcomes.
Benefits
Extensively supported in scientific literature and major guidelines, the ELF Test is the first blood test granted De Novo marketing authorization for use as a prognostic marker in patients with advanced fibrosis due to MASH.
- Outperformed liver biopsy in predicting liver-related events (LRE).2
- Demonstrated strong prediction of one-year LRE risk, outperforming other noninvasive tests.3
- Measures markers of fibrotic disease activity to generate a score used to predict risk of liver-related clinical outcomes and disease progression.4
Designed for operational simplicity and scalability, the ELF Test runs on both Atellica® immunoassay analyzers and ADVIA® Centaur systems, enabling seamless integration into existing workflows. With a simple blood draw and rapid access to results, clinicians can assess disease progression risk without the delays associated with lengthy referral pathways or invasive procedures. The ELF Test is also broadly accessible through national laboratory networks, leading health systems, and regional reference labs.
- No fasting required
- Simple blood test requiring only one additional red-top serum tube
- Consistent performance across diverse patient populations
- Fully automated ELF score calculation for standardization and reliable results
1. Lower risk of disease progression and liver-related events
2. Mid risk of disease progression and liver-related events
3. Higher risk of disease progression and liver-related events
The ELF Test is a simple, blood-based tool that measures three biomarkers of active liver fibrosis, which are central to fibrogenesis and fibrolysis. Together, these biomarkers reveal how the liver is remodeling in real time by generating a clear, easy-to-interpret numerical ELF Score that helps clinicians assess risk of disease progression and liver-related events to help guide patient management decisions.
Extensively supported in scientific literature and major guidelines, the ELF Test is the first blood test granted De Novo marketing authorization for use as a prognostic marker in patients with advanced fibrosis due to MASH.
- Outperformed liver biopsy in predicting liver-related events (LRE).2
- Demonstrated strong prediction of one-year LRE risk, outperforming other noninvasive tests.3
- Measures markers of fibrotic disease activity to generate a score used to predict risk of liver-related clinical outcomes and disease progression.4
Technical Details
Number of tests per kit
50
Sample type
- Serum
Hyaluronic Acid (HA)
20 µL
Amino-Terminal Propeptide of Type III Procollagen (PIIINP)
20 µL
Tissue Inhibitor of Matrix Metalloproteinase I (TIMP-1)
25 µL
Hyaluronic Acid (HA)
3.0-1000.00 ng/mL
Amino-Terminal Propeptide of Type III Procollagen (PIIINP)
1.0-150.00 ng/mL
Tissue Inhibitor of Matrix Metalloproteinase I (TIMP-1)
5.0–1300.0 ng/mL
On-board Stability
28 days
Atellica Solution
- Designed for high-volume labs managing broad cardiometabolic testing demands, the Atellica Solution delivers scalable automation, workflow efficiency, and standardized performance – including the ELF Test to help assess risk of disease progression and liver-related events in patients with advanced fibrosis (F3 or F4) due to MASH.
Atellica IM Analyzer
Designed for mid-size labs interested in immunoassay testing, the Atellica IM Analyzer helps streamline and automate liver disease risk assessment with the ELF Test while supporting operational efficiency and consistent, reliable performance.
Atellica CI Analyzer
Designed for lower-volume labs seeking integrated immunoassay and clinical chemistry capabilities in a compact footprint, the Atellica CI Analyzer helps support the growing needs of liver disease patient management by enabling access to the ELF Test alongside routine testing workflows.
More Information
Order the ELF Test
The ELF Test is currently available across multiple channels, health systems, and regional reference labs.
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