Siemens Healthcare Diagnostics has announced that its enhanced liver fibrosis (ELF) test has been CE-marked for use on Advia Centaur immunoassay systems.
The fully automated standardised direct biomarker panel is said to offer clinicians a quick, reliable and minimally invasive blood test option to assess liver fibrosis, a leading indicator of chronic liver disease (CLD), with results in less than one hour.
With the addition of the ELF test, Siemens offers an integrated portfolio of diagnostic solutions for managing liver health, which includes routine chemistry tests, hepatitis serology tests, viral load testing and ultrasound systems.
The ELF test is a simple, standardised blood test that 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, the current standard of care for liver fibrosis diagnosis.
The ELF test has been clinically validated on an Immuno-1 auto analyser in an international multi-centre study with a mix of patient groups, including viral hepatitis, non-alcoholic fatty liver disease (NAFLD), and alcoholic patient groups.
Additionally, a seven-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.
