Hepatitis C Virus (HCV) FibroSure®

Assessment of liver status following a diagnosis of HCV. Baseline determination of liver status before initiating HCVtherapy. Posttreatment assessment of liver status six months after completion of therapy. Noninvasive assessment of liver status in patients who are at increased risk of complications from a liver biopsy.

This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the US Food and Drug Administration(FDA). The FDA has determined that such clearance or approval is not necessary.

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Halfon P, Bourliere M, Deydier R, et al. Independent prospective multicenter validation of biochemical markers (fibrotest-actitest) for the prediction of liver fibrosis and activity in patients with chronic hepatitis C: The fibropaca study. Am J Gastroenterol. 2006 Mar; 101(3):547-555. PubMed 16542291

Poynard T, Imbert-Bismut F, Munteanu M, et al. Overview of the diagnostic value of biochemical markers of liver fibrosis (FibroTest, HCV FibroSure) and necrosis (ActiTest) in patients with chronic hepatitis C. Comp Hepatol. 2004 Sep 23; 3(1):8-19. PubMed 15387887

Poynard T, Munteanu M, Imbert-Bismut F, et al. Prospective analysis of discordant results between biochemical markers and biopsy in patients with chronic hepatitis C. Clin Chem. 2004 Aug; 50(8):1344-1355. PubMed 15192028