NASH FibroSure® Plus

Serum

3.5 mL

2 mL

Gel-barrier tube is preferred. Red-top tube is acceptable.

Patient should be fasting for at least eight hours.

This test is a noninvasive assessment of liver status in patients with nonalcoholic fatty liver disease (NAFLD), now known as metabolic dysfunction-associated steatotic liver disease (MASLD). Quantitative results of 10 biochemicals in combination with age and gender are analyzed using a computational algorithm to provide a quantitative surrogate marker (0.0-1.0) of liver fibrosis (Metavir F0-F4), hepatic steatosis (0.0-1.0, S0-S3), and nonalcoholic steatohepatitis (NASH) (0.0-0.75, N0-N2). The absence of steatosis (S<0.41) precludes the diagnosis of NASH, now known as metabolic dysfunction-associated steatohepatitis (MASH).

NASH FibroSure® Plus is recommended for patients with suspected NAFLD, now known as metabolic dysfunction-associated steatotic liver disease (MASLD). It is not recommended for patients with other liver diseases. It is also not recommended in patients with Gilbert disease, acute hemolysis, acute viral hepatitis, drug induced hepatitis, genetic liver disease, autoimmune hepatitis and/or extra- hepatic cholestasis. Any of these clinical situations may lead to inaccurate quantitative predictions of fibrosis.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

See individual test components.