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Fibroscan Performance/FDA Approved
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FDA Approves FibroScan® for Non-invasive Liver Diagnosis - (05/22/13)
Diagnostic accuracy of FibroScan and comparison to liver fibrosis biomarkers in chronic viral hepatitis: A multicenter prospective study (the FIBROSTIC study)
Journal of Hepatology (December 2010)
http://www.natap.org/2010/HCV/120510_01.htm
"The overall accuracy of FibroScan® was as good as or better than that of other non-invasive methods......the comparison with FibroScan was based on results of 1197 (Fibrotest), 1204 (Fibrometre), 1272 (APRI), and 1238 patients (Hepascore)......The diagnostic accuracy of TE was significantly higher than that of any biomarker except Fibrometre® in diagnosing cirrhosis (p=0.007 to p<0.0001)........The diagnostic accuracy of non-invasive tests was high for cirrhosis, but poor for significant fibrosis. A clinically relevant gain in the likelihood of diagnosis was achieved in a low proportion of patients. Although the diagnosis of cirrhosis may rely on non-invasive tests, liver biopsy is warranted to diagnose intermediate stages of fibrosis.......The overall accuracy of FibroScan® was high (AUROC 0.89 and 0.90, respectively) and significantly higher than that of biomarkers in predicting cirrhosis (AUROC 0.77-0.86). All non-invasive methods had a moderate accuracy in predicting significant fibrosis (AUROC 0.72-0.78).........According to current practice guidelines, significant fibrosis (F2) is a frequent selection criterion for antiviral treatment of HCV and HBV chronic hepatitis, but the use of non-invasive tests to stage liver fibrosis remains highly controversial. In summary, our study has established that non-invasive tests, especially FibroScan®, may be useful in the prediction of cirrhosis. However, it supports guideline conclusions that non-invasive tests should not replace liver biopsy in routine clinical practice for the detection of significant fibrosis that may warrant treatment [2], [3]."
Technique recommended for Fibroscan®
The right lobe of the liver is targeted through an intercostal space access while the patient is lying in the dorsal decubitus position with the right arm in maximal abduction. An area of the liver at least 6 cm thick and free of large vessels is identified for examination under FibroScan® guidance. The rate of successful measurements, i.e. the ratio of validated to total measurements, is calculated by the machine. Liver elasticity is expressed as the median value of all valid measurements in kiloPascals (kPa).
Performance of Transient Elastography for the Staging of Liver Fibrosis: A Meta-Analysis
http://www.natap.org/2008/HCV/041908_02.htm
Gastroenterology April 2008
"Transient elastography can be performed with excellent diagnostic accuracy and independent of the underlying liver disease for the diagnosis of cirrhosis. However, for the diagnosis of significant fibrosis, a high variation of the AUROC was found that is dependent on the underlying liver disease."
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