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Test Name:

  • SBMF No:
  • Performance Lab Name:
    Laboratory Corporation of America (via ARUP)
  • Test Mnemonic:
  • ABN:
    Required – Not FDA-Approved
  • CPT Code:
  • Ref Lab Test No:
    ARUP# 2008868 | LabCorp# 550140
  • Test Includes:
    Alpha 2-Macroglobulins, Qn; Haptoglobin; Apolipoprotein A-1; Bilirubin, Total; GGT; ALT (SGPT) P5P; AST (SGOT) P5P; Cholesterol, Total; Glucose, Serum; Triglycerides
  • Also Known As:
    Fatty Liver Disease; NAFLD; Nonalcoholic Fatty Liver Disease; Steatohepatitis
  • Also See:

    Ordering Guidance:
    Only intended for use in patients with non-alcoholic liver disease (NAFLD); results may be inaccurate in patients with other etiologies of liver disease.

  • Patient Prep:
    Patient should be fasting for at least eight hours.
  • Spec Collect:
    Red top (serum) or Gold top (SST) tube. Mix by inverting tube 5 times.
  • Spec Process:
    Allow specimen to clot completely at room temperature. Centrifuge to separate from cells ASAP or within 2 hours of collection and transfer 3.5 mL serum to a screw-capped plastic transport tube. (Min: 2 mL)
  • Spec Store Transport:
    CRITICAL FROZEN. Separate specimens must be submitted when multiple tests are ordered.
  • Spec Stability:
    Room temperature: Unacceptable
    Refrigerated: 72 hours
    Frozen: Indefinitely
  • Spec Reject:
    Gross hemolysis; gross lipemia; improper labeling; nonfasting specimen; patient less than 14 years of age
  • Spec Remarks:
    Patient age, gender, height, and weight must be included on the test request form. (Required for result calculations)
  • Methodology:
    Semi-Quantitative Immunologic; Colorimetry; Kinetic; Nephelometry
  • 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, 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 nonalcoholic steatohepatitis (NASH) (0.0‑0.75, N0‑N2). The absence of steatosis (S<0.38) precludes the diagnosis of NASH.
  • Interpretive Data:

    NASH FibroSure® is recommended for patients with suspected nonalcoholic fatty liver disease. It is not recommended for patient with other liver diseases. It is also not recommended in patients with Gilbert disease, acute hemolysis, acute hepatitis, acute inflammation of the liver, autoimmune hepatitis, 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.

  • Day Run:
  • Time Reported:
    Within 2 weeks
  • Test Type:
  • Medicare HCPCSCode:
    This test is a Multianalyte Assay with Algorithmic Analysis (MAAA). Some payers, including Medicare, do not recognize MAAA CPT codes for payment and require the individual CPTs for each analyte in the analysis. Consult the payer being billed to determine which CPT code(s) to use. The analytes included in this MAAA are: Apolipoprotein A1 (CPT 82172); Bilirubin, Total (CPT 82247); Cholesterol, Total (CPT 82465); Glucose, Serum (CPT 82947); Gamma-Glutamyl Transferase (GGT) (CPT 82977); Haptoglobin (CPT 83010); Alpha-2-Macroglobulin (CPT 83883); Aspartate Aminotransferase (AST) (CPT 84450); Alanine Aminotransferase (ALT) (CPT 84460); and Triglycerides (CPT 84478).