Focus of the Report: This report focuses on the HCV-FibroSure blood test for detection and staging of liver damage in patients infected with hepatitis C virus (HCV).
Technology Description: The FibroSure test (marketed as FibroTest outside the United States) measures blood levels of bilirubin, gamma-glutamyl transferase, alanine aminotransferase (ALT), α2-macroglobulin, apolipoprotein-A1, and haptoglobin, which are combined with patient age and sex. The first 3 markers are common in liver function test panels.
Liver biopsy is considered the reference standard for diagnosing inflammation, fibrosis, and cirrhosis in patients with chronic liver disease. Less invasive or noninvasive tests have been developed as alternatives since liver biopsy has limitations, including pain, bleeding, and other complications, as well as sampling error. The goals of blood tests to detect biomarkers of liver damage, such as FibroSure, are to accurately assess the presence and extent of fibrosis, to predict long-term outcomes such as hepatic decompensation and need for liver transplant, and to guide treatment decisions.
Controversy: The FibroSure test is more complex than many other blood tests for evaluating liver disease in patients with HCV since it requires measurement of several uncommon blood markers. Compared with simpler methods, the FibroSure test may not provide a large enough increase in accuracy to support its use for most patients.
What is the accuracy of FibroSure relative to histopathology in detecting and staging hepatic fibrosis (clinical validity) in patients infected with HCV?
What is the accuracy of FibroSure relative to other technologies in detecting and staging hepatic fibrosis in patients infected with HCV?
Does FibroSure provide useful information for predicting clinical outcomes (clinical validity) in patients with HCV infection?
Does the use of FibroSure change treatment decisions or improve health outcomes (clinical utility)?
Are there any safety issues associated with the FibroSure test?
Have definitive patient selection criteria been established for the use of FibroSure in detecting and staging hepatic fibrosis in patients infected with HCV?
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