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NASH FibroSure® Plus
CPT:
[MAAA: 0003M] or 82172; 82247; 82465; 82947; 82977; 83010; 83883; 84450; 84460; 84478
Synonyms
- Fatty Liver Disease
- Liver Fibrosis
- MASH
- MASLD
- Metabolic Dysfunction-Associated Steatohepatitis
- Metabolic Dysfunction-Associated Steatotic Liver Disease
- Nonalcoholic Steatohepatitis
- Noninvasive Liver Biopsy
Special 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.
Expected Turnaround Time
4 - 6 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Information
Related Documents
For more information, please view the literature below.
NASH FibroSure® Plus: Non-invasive testing for assessing NASH
Specimen Requirements
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, and transfer serum to a transfer tube.
|
Separate serum from cells within two hours of collection |
|
Separate serum from cells within two hours of collection, and transfer serum to a transfer tube. |
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.
Stability Requirements
| Temperature | Period |
|---|---|
| Room temperature | 72 hours (stability provided by manufacturer or literature reference) |
| Refrigerated | 72 hours (stability provided by manufacturer or literature reference) |
| Frozen | 7 days (stability provided by manufacturer or literature reference) |
| Freeze/thaw cycles | Stable x1 (stability provided by manufacturer or literature reference) |
Patient Preparation
Patient should be fasting for at least eight hours.
Causes for Rejection
Gross hemolysis; gross lipemia; improper labeling; nonfasting specimen; patient younger than 14 years of age
Test Details
Use
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).
Limitations
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.
Methodology
See individual test components.
References
Poynard T, Peta V, Munteanu M, et al. The diagnostic performance of a simplified blood test (SteatoTest-2) for the prediction of liver steatosis. Eur J Gastroenterol Hepatol. 2019 Mar;31(3):393-402.30516570
Poynard T, Munteanu M, Charlotte F, et al. Diagnostic performance of a new noninvasive test for nonalcoholic steatohepatitis using a simplified histological reference. Eur J Gastroenterol Hepatol. 2018 May;30(5):569-577.29406435
Ratziu V, Massard J, Charlotte F, et al. Diagnostic value of biochemical markers (FibroTest-FibroSURE) for the prediction of liver fibrosis in patients with non-alcoholic fatty liver disease. BMC Gastroenterol. 2006 Feb 14;6:6.16503961
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