NASH FibroSure® Plus

CPT: [MAAA: 0003M] or 82172; 82247; 82465; 82947; 82977; 83010; 83883; 84450; 84460; 84478
Updated on 08/20/2024
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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



Related Documents


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

TemperaturePeriod
Room temperature72 hours (stability provided by manufacturer or literature reference)
Refrigerated72 hours (stability provided by manufacturer or literature reference)
Frozen7 days (stability provided by manufacturer or literature reference)
Freeze/thaw cyclesStable 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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