ELF Testing Service
Siemens Healthcare Laboratory - Our ELF™ Testing Services – are used extensively in metabolic therapy clinical trials
Siemens Enhanced Liver Fibrosis (ELF)™ Test*
A minimally invasive simple standardized blood test
Potential pharmaceutical applications
- Liver fibrosis related therapy trials (patient selection/prognosis/monitoring)
- Used in NASH, PBC, PSC therapy clinical trials
Availability in US
- Testing center for ELF in US for clinical trials testing applications
- 2019 - Launched ELF clinical testing service in US*
Clinical Use of the ELF Test™
- The National Institute for Health and Care Excellence (NICE) NAFLD guidelines recommend the ELF Test to test for and monitor liver fibrosis/advanced liver fibrosis in people diagnosed with NAFLD†
- Gilead Sciences and Renown Health have partnered with Siemens Healthineers to offer ELF testing for over 30,000 Nevada NASH study participants through Healthy Nevada
- The ELF Test* helps identify people most at risk for progressing to cirrhosis and liver-related outcomes
- The ELF™ Testing service is available in US from Siemens’ CLIA-certified lab in Berkeley, CA, USA for clinical trial applications
Test Description:
The Enhanced Liver Fibrosis (ELF)* test is a multivariate index immunoassay intended to provide an algorithm score based upon quantitative measurements of hyaluronic acid (HA), amino-terminal pro-peptide of type III pro-collagen (PIIINP), and tissue inhibitor of metalloproteinase 1 (TIMP-1) in human serum.
- Sample Type: Serum
- Sample Size: 1.0 mL Serum
- Specimen Storage: Freeze serum (separated from clot) at ≤ –20°C in a non-cycling freezer for no longer than 3 months or preferably –60 to –90°C for long term storage
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* Test Information: The ELF score is indicated, in conjunction with other laboratory findings and clinical assessments, as a prognostic marker in patients with chronic liver disease to assess the risk of progression to cirrhosis and liver-related clinical events. This test was developed and its performance characteristics determined by the Siemens Healthcare Laboratory. It has not been cleared or approved by the US Food and Drug Administration. The laboratory is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research.
† NICE guideline “Non-alcoholic fatty liver disease (NAFLD): assessment and management.” Published 6 July 2016
References:
Day J, Patel P, Parkes J, Rosenberg W. Derivation and performance of standardized Enhanced Liver Fibrosis (ELF) test thresholds for the detection and prognosis of liver fibrosis. The Journal of Applied Laboratory Medicine. 2018 Oct 11:jalm-2018
