NASH FibroSure® Plus
Also known as: Fatty Liver Disease, NAFLD, Nonalcoholic Fatty Liver Disease, Noninvasive Liver Biopsy, Steatohepatitis
Use
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.
Special Instructions
The patient's age and gender must be submitted. Fasting for at least eight hours is recommended.
Limitations
NASH FibroSure® Plus is recommended for patients with suspected NAFLD, now known as MASLD. It is not recommended for patients with other liver diseases. It is also not recommended for 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. If any markers are unusually high or low, the algorithm may not be able to calculate one or more of the scores accurately. This test has not been cleared or approved by the FDA.
Methodology
Other
Biomarkers
LOINC Codes
- 93691-4
- 48795-9
- 48794-2
- 93695-5
- 93696-3
- 93692-2
- 93693-0
- 62364-5
- 1835-8
- 4542-7
- 1869-7
- 1975-2
- 2324-2
- 1743-4
- 30239-8
- 2093-3
- 2345-7
- 2571-8
- 8264-4
- 93694-8
- 82364-5
Result Turnaround Time
4-6 days
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
3.5 mL
Minimum Volume
2 mL
Container
Gel-barrier tube is preferred. Red-top tube is acceptable.
Collection Instructions
Separate serum from cells within two hours of collection, and transfer serum to a transfer tube.
Patient Preparation
Patient should be fasting for at least eight hours.
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.
Causes for Rejection
Gross hemolysis; gross lipemia; improper labeling; nonfasting specimen; patient younger than 14 years of age
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 72 hours |
| Refrigerated | 72 hours |
| Frozen | 7 days |