Recommendation for NHSScotland

Due to the limited comparative evidence available for the direct liver fibrosis tests of interest, SHTG is unable to provide advice to NHSScotland on the most accurate and cost-effective test for detecting and staging liver fibrosis. Further research is needed to inform advice on the diagnostic value of direct serum biomarkers compared with each other and with Fibroscan® and ARFI elastography. 

The two direct imaging tests (Fibroscan® and acoustic radiation force impulse (ARFI) elastography) had similar diagnostic accuracy for detecting significant fibrosis and cirrhosis, and are likely to be the most clinically useful direct liver fibrosis tests in secondary care settings. None of the identified studies evaluated fibrosis tests in a primary care setting.

The most cost-effective liver fibrosis testing option varied by underlying liver disease, was subject to uncertainty and sensitive to changes in model parameters or assumptions.

NHSScotland is required to consider the Scottish Health Technologies Group (SHTG) advice.

What were we asked to look at?

We were asked to review the published literature to provide advice on the most accurate and cost-effective direct test (ELF test™, hyaluronic acid, P3NP, Fibroscan® or ARFI elastography) for detecting and staging liver fibrosis and cirrhosis in patients with diagnosed or suspected nonalcoholic fatty liver disease, alcohol-related liver disease, or viral hepatitis.  

Why is this important?

Direct tests are potentially useful for detecting liver fibrosis and cirrhosis but there is currently a lack of consistency in access to, and use of, these tests in Scotland.

Identifying the most accurate and cost-effective test(s) for diagnosing liver fibrosis would facilitate early intervention to prevent disease progression, increase fibrosis diagnosis and help ensure that patients receive the most appropriate care.

Referred by

Scottish Clinical Biochemistry Managed Diagnostic Network