ASH FibroSure®

CPT: [MAAA: 0002M] or 82172; 82247; 82465; 82947; 82977; 83010; 83883; 84450; 84460; 84478
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Test Details

Synonyms

  • Alcoholic Liver Disease
  • Noninvasive Liver Biopsy
  • Steatohepatitis

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.

Specimen Requirements

Specimen

Serum

Volume

3.5 mL

Minimum Volume

2 mL

Container

Red-top tube or gel-barrier tube

Patient Preparation

Patient should be fasting for at least eight hours.

Collection

Separate serum from cells within two hours of collection.

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

Clinical Information

Special Instructions

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

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. 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. 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. 16580087

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
550180 ASH FibroSure 550191 Fibrosis Score 48795-9
550180 ASH FibroSure 550192 Fibrosis Stage 48794-2
550180 ASH FibroSure 550181 Steatosis Score N/A
550180 ASH FibroSure 550183 Steatosis Grade N/A
550180 ASH FibroSure 550184 ASH Score 48792-6
550180 ASH FibroSure 550185 ASH Grade 48793-4
550180 ASH FibroSure 550199 Height: in 3137-7
550180 ASH FibroSure 550201 Weight: LBS 3141-9
550180 ASH FibroSure 122137 Alpha 2-Macroglobulins, Qn mg/dL 1835-8
550180 ASH FibroSure 001629 Haptoglobin mg/dL 4542-7
550180 ASH FibroSure 016874 Apolipoprotein A-1 mg/dL 1869-7
550180 ASH FibroSure 001100 Bilirubin, Total mg/dL 1975-2
550180 ASH FibroSure 001960 GGT IU/L 2324-2
550180 ASH FibroSure 001547 ALT (SGPT) P5P IU/L 1743-4
550180 ASH FibroSure 001125 AST (SGOT) P5P IU/L 30239-8
550180 ASH FibroSure 001067 Cholesterol, Total mg/dL 2093-3
550180 ASH FibroSure 001036 Glucose, Serum mg/dL 2345-7
550180 ASH FibroSure 001175 Triglycerides mg/dL 2571-8
550180 ASH FibroSure 550188 Interpretation: N/A
550180 ASH FibroSure 550107 Fibrosis Scoring: N/A
550180 ASH FibroSure 550189 Steatosis Grading N/A
550180 ASH FibroSure 550190 ASH Scoring N/A
550180 ASH FibroSure 550135 Limitations: 8251-1
550180 ASH FibroSure 550193 Comment: 77202-0
550180 ASH FibroSure 123098 Comment: 77202-0

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