This test is a noninvasive assessment of liver status in patients with nonalcoholic fatty liver disease (NAFLD). 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.

NASH FibroSure® Plus is recommended for patients with suspected nonalcoholic fatty liver disease. 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.

Patient should be fasting for at least eight hours.

Marble Serum Seperator Tube (SST) 8.5 mL

Immediatley following collection, mix sample by inverting 5 times

1. Allow sample to clot for a minimum of 30 minutes
2. Spin within two (2) hours of sample collection
3. Transfer serum to a Screw-cap polypropylene frozen transport vial/tube - 4mL (LabCorp), labelled as serum
4. Freeze

Screw-cap polypropylene frozen transport vial/tube - 4mL (LabCorp)

Red serum vial/tube, 10 mL

or 

Two (2) Gold serum separator (SST) tube

1. Allow sample to clot for a minimum of 30 minutes
2. Spin within two (2) hours of sample collection
3. Transfer serum to a Screw-cap polypropylene frozen transport vial/tube - 4mL (LabCorp), labelled as serum
4. Freeze

Screw-cap polypropylene frozen transport vial/tube - 4mL (LabCorp)

Patient's age and gender

Frozen (preferred) - 7 days

Refrigerated - 72 hours

Ambient - 72 hours

• Gross hemolysis
• Gross lipemia
• Improper labeling
• Nonfasting specimen
• Patient <14 years of age

An interpretive report will be provided

Medical necessity