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New standard for liver fibrosis assessment

Siemens Healthineers Haberleri | 10-02-2012

Siemens' Enhanced Liver Fibrosis (ELF) blood test1, for use outside the U.S. on the ADVIA Centaur® Immunoassay Systems, is an innovative, automated, standardized direct biomarker panel for the assessment of liver fibrosis– a leading indicator of chronic liver disease (CLD), such as cirrhosis and liver cancer, which are among the top ten causes of death worldwide.2, 3 

The ELF test offers clinicians a quick, reliable, minimally invasive test option to assess liver fibrosis with results in less than one hour. With the addition of the ELF test, Siemens is currently the only company to offer an integrated portfolio of diagnostic solutions for managing liver health, which includes routine chemistry tests, hepatitis serology tests, viral load testing, and ultrasound systems.

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The ELF test score

The ELF test assesses the severity of liver fibrosis by combining three direct serum biomarkers – hyaluronic acid (HA), procollagen III amino terminal peptide (PIIINP), and tissue inhibitor of metalloproteinase 1 (TIMP-1) – in an algorithm. The result is an ELF score, which correlates to the level of liver fibrosis assessed by liver biopsy,3 the current standard of care for liver fibrosis diagnosis. 

“The discovery of the ELF markers represents a significant advance in the diagnosis of patients with liver disease,” said William Rosenberg, MBBS, D. Phil, Peter Scheuer Chair in Liver Diseases Joint Director of the Centre for Hepatology University College London, UK. “Of particular benefit, the ELF test can help to identify patients with mild-to-moderate liver fibrosis, which is usually asymptomatic, so that clinicians are able to intervene before significant damage to the liver occurs.”

Easy assessment

“While liver biopsy is the standard for assessing liver fibrosis, unfortunately, there are challenges with this procedure, including patient discomfort and difficulties in interpreting the results,” explains Dave Hickey, CEO, Chemistry, Immunoassay, Automation, and Diagnostics IT Business Unit, Siemens Healthcare Diagnostics. “By offering an automated, routine, minimally invasive blood test, Siemens provides an additional tool to physicians to aid them to easily assess the severity of liver fibrosis in their patients with chronic liver disease.”

Clinically validated

The ELF test has been clinically validated on an IMMUNO-1 auto analyzer in an international multicentre study with a mix of patient groups, including viral hepatitis, non-alcoholic fatty liver disease (NAFLD), and alcoholic patient groups. Additionally, a 7-year follow-up study involving more than 450 patients has shown that the ELF markers are at least comparable to liver histology at predicting clinical outcomes of CLD.

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1 Not available for sale in the U.S.

2 Griffiths et al., (2005) “Leading Causes of Death in England and Wales—How Should We Group Causes?” Health Statistics Quarterly 28:6–17.

3 Bosetti et al., (2007) “Worldwide Mortality from Cirrhosis: An Update to 2002,” Journal of Hepatology 46(5):827–39. 

4 Rosenberg et al, (2004), “Serum Markers Detect the Presence of Liver Fibrosis: A Cohort Study,” Gastroenterology 127:1704-1703 

5 Parkes et al., (2010) “Enhanced Liver Fibrosis Test Can Predict Clinical Outcome in Patients with Chronic Liver Disease,” Gut (online Aug 2010)

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