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The stage of fibrosis is the most important single predictor of significant morbidity and mortality in individuals with hepatitis C and other chronic liver diseases. Investigators have sought a noninvasive alternative to liver biopsy for both as an initial assessment and then as a monitoring tool to assess response to therapy. A variety of laboratory tests have been proposed as an alternative to liver biopsy. The most highly marketed test in the United States is FibroSURE, which is marketed by LabCorp.

Three different FibroSURE tests are available. HCV FibroSURE uses a combination of six serum markers of liver function plus age and gender in a patented algorithm to generate a measure of fibrosis and necroinflammatory activity in the liver corresponding to the METAVIR scoring system for stage of fibrosis and grade of necroinflammatory activity (NI). The serum markers include measurements of alpha-2 macroglobulin, haptoglobin, gamma glutamyl transpeptidase (GGT), ALT, and apolipoprotein A1. Quantitative results of 6 biochemical tests are analyzed using a computational algorithm to provide a quantitative surrogate marker (0.0-1.0) for liver fibrosis (METAVIR F0-F4) and for necroinflammatory activity (METAVIR A0-A3).

Fibrosis Score




Stage F0

No fibrosis

0.21 – 0.27



0.27 – 0.31


Portal Fibrosis

0.31 – 0.48

Stage F1 – F2


0.48 – 0.58

Stage F2

Bridging fibrosis few septa

0.58 – 0.72

Stage F3

Bridging fibrosis many septa

0.72 – 0.74

Stage F3 – F4



Stage F4


NI  Score





No Activity

0.17 – 0.29

A0 – A1


0.29 – 0.36


Minimal activity

0.36 – 0.52



0.52 – 0.60


Moderate activity

0.60 – 0.62





Severe activity

In patients with HCV infection FibroSURE has been used to determine liver status before initiation of HCV therapy and six months after completion of therapy. It is also ordered for patients who are at increased risk of complications from a liver biopsy.  In patients with HCV infection, the negative predictive value of a FibroSURE score <0.31 is 85% compared to liver biopsy and the positive predictive value of a Fibrotest score >0.48 is 61%.

Evidence based guidelines on the diagnosis, management and treatment of hepatitis C published by the American Association for the Study of Liver Diseases in 2004 stated that commercially available liver fibrosis markers are insufficiently accurate to support their routine use. The same organization published updated guidelines in 2009 and again indicated that noninvasive tests should not replace liver biopsy in routine clinical practice.

In a technical review on the management of hepatitis C, the American Gastroenterology Association (2006) also stated that laboratory markers do not accurately predict the degree of necroinflammatory activity or the level of fibrosis in the liver. Liver biopsy remains the gold standard for determining histologic grade and stage.

ASH FibroSURE consists of ten serum markers including ALT, A2-macroglobulin, apolipoprotein A-1, total bilirubin, GGT, haptoglobin, AST, glucose, total cholesterol and triglycerides. A prognostic algorithm is used to report quantitative scores for fibrosis, steatosis and alcoholic steatohepatitis. NASH FiborSURE includes the same ten biochemical assays as ASH FibroSURE but the algorithm is used to calculate scores for fibrosis, steatosis and nonalcoholic steatohepatitis.

The performance characteristics of FibroSURE have been determined by LabCorp. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Currently, evidence based data do not support the use of these markers. Insurance companies consider this test to be experimental, investigational and not medically necessary.

HCV FibroSURE should not be ordered if patients have any of the following conditions: Gilbert Disease, acute hemolysis associated with ribavirin therapy, acute hepatitis, extra-hepatic cholestasis, transplant patients, and/or renal insufficiency patients. Any of these clinical situations may lead to inaccurate quantitative predictions of fibrosis and necroinflammatory activity.

Specimen requirement is 5 mL of blood drawn into a plain red top tube or gel tube. Serum should be separated from cells within 1 hour and frozen in two plastic screw-capped tubes for transportation. All FibroSure tests are performed and interpreted by LabCorp.

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