ASH FibroSure®

CPT: [MAAA: 0002M] or 82172; 82247; 82465; 82947; 82977; 83010; 83883; 84450; 84460; 84478
Updated on 11/12/2024
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Synonyms

  • Alcoholic Liver Disease
  • Noninvasive Liver Biopsy
  • Steatohepatitis

Special Instructions

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


Expected Turnaround Time

3 - 6 days



Related Documents


Specimen Requirements


Specimen

Serum


Volume

3.5 mL


Minimum Volume

2 mL


Container

Red-top tube or gel-barrier tube


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.

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
Room temperature
Period72 hours (stability provided by manufacturer or literature reference)
Refrigerated
Period72 hours (stability provided by manufacturer or literature reference)
Frozen
Period7 days (stability provided by manufacturer or literature reference)
Freeze/thaw cycles
PeriodStable x1 (stability provided by manufacturer or literature reference)
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 intended for noninvasive assessment of liver status in patients with alcoholic liver disease. Quantitative results of 10 biochemicals in combination with age, gender, height, and weight 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 alcoholic steatohepatitis (ASH) (0.0-1.0, H0-H3).


Limitations

ASH FibroSure® is recommended for patients with suspected alcoholic 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 hepatitis, acute inflammation of the liver, extrahepatic cholestasis, transplant patients, and/or renal insufficiency patients. 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 US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.


References

Naveau S, Raynard B, Ratziu V, et al. Biomarkers for the prediction of liver fibrosis in patients with chronic alcoholic liver disease. Clin Gastroenterol Hepatol. 2005 Feb; 3(2):167-174. PubMed 15704051
Poynard T, Ratziu V, Naveau S, et al. The diagnostic value of biomarkers (SteatoTest) for the prediction of liver steatosis. Comp Hepatol. 2005 Dec 23; 4:10. PubMed 16375767
Thabut D, Naveau S, Charlotte F, et al. The diagnostic value of biomarkers (AshTest) for the prediction of alcoholic steatohepatitis in patients with chronic alcoholic liver disease. J Hepatol. 2006 Jun; 44(6):1175-1185. PubMed 16580087

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