NASH FibroSure® Plus

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Category:

Turnaround Time: 3 - 6 days
CPT Code:  [MAAA: 0003M] or 82172; 82247; 82465; 82947; 82977; 83010; 83883; 84450; 84460; 84478
Test Type: 3.5 mL Serum

Overview:

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.

Collection Details:

Patient Preparation:

Patient should be fasting for at least eight hours.

Collection Instructions:

The patient's age, gender, height, and weight at the time of collection must be submitted for FibroSure® Plus testing.

Specimen: Serum

Volume: 3.5 mL

Minimum Volume: 2 mL

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

Collection: Separate serum from cells within two hours of collection.

Storage Instructions:  Specimen can be stored refrigerated at 2°C to 8°C for 72 hours and frozen at -70°C for seven days. Frozen samples are stable for one freeze/thaw cycle.