The ELF test from Siemens Healthcare Diagnostics is the first automated test for liver fibrosis, which is an important indicator of Chronic Liver Disease - the UK's fifth biggest killer.
According to Siemens, the use of a simple blood test to accurately identify those with significant liver disease will aid the appropriate targeting of aversion methods, such as weight loss, exercise and therapeutic interventions.
Liver fibrosis refers to the accumulation of tough, fibrous scar tissue in the liver.
The formation of this tissue, through the deposition of new collagen, is a normal bodily response to injury, but in fibrosis this healing process goes awry.
The traditional reference standard for detecting and assessing liver fibrosis has been trans-abdominal needle biopsy of the liver.
Siemens claims that small sample size and the patchy distribution of some liver pathology can result in a significant degree of sampling error.
Also, the procedure can be painful and hazardous, with bleeding caused in approximately one in 1,000 cases and death in one in 10,000 cases.
This first fully automated standardised direct biomarker panel is designed to offer doctors a quick, reliable and minimally invasive blood test option to assess liver fibrosis with results in less than one hour.
It was created to replace standard liver function tests, which do not accurately reflect the true extent of fibrotic damage or may detect it too late.
Fibrosis is not evenly distributed throughout the liver and because such a small amount of biological material is sampled, 55 per cent of 15mm biopsies may be misclassified.
Larger biopsies can be performed but even with 25mm sections, 45 per cent will be erroneous.
Siemens' ELF test, however, 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.
This automated, routine and minimally invasive blood test provides an additional tool to physicians to help them assess the severity of liver fibrosis in their patients with chronic liver disease.
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.