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NASH FibroSure® Plus
Test Code13006
CPT Codes
0003M<br><strong>This test is not available for New York patient testing</strong><br>Restricted Client Code
Preferred Specimen
3.5 mL serum collected in a gel-barrier tube
Patient Preparation
Patient should be fasting for at least 8 hours
Minimum Volume
2 mL
Other Acceptable Specimens
Red-top tube (no gel)
Instructions
The patient's age and gender must be submitted, but the patient's height and weight are not required for NASH FibroSure® Plus testing.
Separate serum from cells within two hours of collection.
Transport Temperature
Frozen
Specimen Stability
Room temperature: 72 hours
Refrigerated: 72 hours
Frozen: 7 days (Frozen samples are stable for 1 freeze/thaw cycle)
Refrigerated: 72 hours
Frozen: 7 days (Frozen samples are stable for 1 freeze/thaw cycle)
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Grossly lipemic • Improper labeling • Non-fasting specimen • Patient younger than 14 years of age
Methodology
Colorimetric • Immunologic • Enzymatic • Kinetic
FDA Status
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.
Setup Schedule
Set up: Mon-Fri; Report available: 4-6 days
Reference Range
See Laboratory Report
Clinical Significance
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.
