From the Guidelines
FibroTest is considered medically necessary for assessing liver fibrosis in patients with chronic liver disease, particularly chronic hepatitis B and C, alcoholic liver disease, and non-alcoholic fatty liver disease (NAFLD). This blood test measures six serum biomarkers to calculate a score that correlates with the degree of liver fibrosis. According to the most recent study 1, FibroTest had an AUC, sensitivity, and specificity of 0.90,79%, and 93% for diagnosing significant fibrosis and 0.87,80%, and 84% for diagnosing cirrhosis, respectively.
Key Points
- FibroTest is a non-invasive alternative to liver biopsy for assessing liver fibrosis
- It is most useful when liver biopsy is contraindicated, unavailable, or refused by the patient
- The test provides a score that correlates with the degree of liver fibrosis, guiding treatment decisions and monitoring disease progression
- Its accuracy may be affected by certain conditions like Gilbert's syndrome, hemolysis, or acute inflammation
- FibroTest should be interpreted alongside clinical findings, other laboratory tests, and imaging studies for comprehensive liver disease management
Limitations and Considerations
- The test can generate false-negative results due to acute inflammation and false-positive results due to hemolysis
- Confirming the results of FibroTest can be time-consuming due to the need for various indicators
- The high cost of the test limits its widespread use
- Ethnic disparities have been observed in the diagnostic performance of VCTE for significant fibrosis and cirrhosis among patients with CHB in Europe and Asia 1
Clinical Application
- FibroTest is considered a cost-effective alternative to liver biopsy for appropriate patients in many healthcare systems
- It is particularly valuable for initial assessment and follow-up monitoring of fibrosis progression or regression in response to treatment
- The test should be used in conjunction with other diagnostic tools and clinical findings to ensure accurate diagnosis and effective management of liver disease.
From the Research
Medically Necessary Use of FibroTest
The use of FibroTest as a medically necessary diagnostic tool is supported by several studies. Key points include:
- FibroTest has been found to have high diagnostic value for fibrosis and necroinflammatory histological activity in patients with chronic hepatitis C 2.
- The test has been shown to be a cost-effective alternative to liver biopsy for the assessment of liver injury in patients with chronic hepatitis C 3.
- FibroTest has been validated in patients with chronic hepatitis C, as well as in those with chronic hepatitis B, alcoholic liver disease, and non-alcoholic fatty liver disease 4.
Diagnostic Accuracy
The diagnostic accuracy of FibroTest has been compared to other non-invasive tests, including transient elastography (FibroScan) and the aspartate transaminase to platelets ratio index (APRI). Key findings include:
- FibroTest has been found to have similar performance to FibroScan and APRI for the diagnosis of significant fibrosis and cirrhosis 5.
- The combined use of FibroScan and FibroTest has been shown to improve diagnostic accuracy and may avoid the need for liver biopsy in most patients with chronic hepatitis C 5.
- A systematic review of diagnostic test accuracy found that FibroTest and FibroScan have excellent utility for the identification of HCV-related cirrhosis, but lesser accuracy for earlier stages of fibrosis 6.
Clinical Use
The clinical use of FibroTest as a medically necessary diagnostic tool is supported by the following points:
- FibroTest can be used as an alternative to liver biopsy for the assessment of liver injury in patients with chronic hepatitis C 2, 3.
- The test can be used to identify patients with significant fibrosis or cirrhosis, and to monitor disease progression 4, 5.
- FibroTest may be used in combination with other non-invasive tests, such as FibroScan, to improve diagnostic accuracy and avoid the need for liver biopsy 5, 6.