South Bend Medical Foundation - Your Community Laboratory

test directorySearch Results

Click here to search again.

Test Name:
Hepatitis C Virus (HCV) FibroSURE

• SBMF No:
  43190
• Performance Lab Name:
  Laboratory Corporation of America
• Test Mnemonic:
  HCV FIBROS
• ABN:
  Required – Not FDA-Approved
• CPT Code:
  82172; 82247; 82977; 83010; 83883; 84460
• LOINC Code:
  19146-0
• Ref Lab Test No:
  550123 (Quest# S50584)
• Test Includes:
  Alanine aminotransferase (ALT)
  A₂-macroglobulin
  Apolipoprotein A-1
  Bilirubin, total
  Gamma glutamyl transferase (GT)
  Haptoglobin
• Also Known As:
  ActiTest
  FibroSURE
  FibroTest
  HCV FibroSURE
• Spec Type:
  Serum
• Spec Container:
  Gold top (SST) or red top (serum) tube
• Min Vol:
  3.0 mL
• Fasting:
  Yes (8 hours)
• Patient Prep:
  Patient should fast for at least eight hours prior to collection
• Spec Collect:
  Routine venipuncture
  Separate samples must be submitted when multiple tests are ordered
• Spec Process:
  Clot 30 minutes
  Promptly centrifuge 15 minutes
  Immediately transfer serum to separate plastic tube and freeze
• Spec Store Transport:
  Frozen
• Spec Stability:
  After separation from cells:
  72 hours refrigerated (2-8°C)
  6 months frozen (-20°C) – Do not use frost-free units that undergo repeated freeze/thaw cycles
• Spec Reject:
  Grossly hemolyzed or lipemic sample
• Spec Remarks:
  Separate serum from cells within one hour of collection
• Methodology:
  Patented artificial intelligence algorithm combines patient’s age, gender, and the results of six biomarkers to generate a measure of fibrosis and necroinflammatory activity in the liver.
• Use:
  

  HCV FibroSure can be used for
   • Assessment of liver status following a diagnosis of HCV
   • Baseline determination of liver status before initiating HCV therapy
   • Post-treatment assessment of liver status six months after completion of therapy
   • Noninvasive assessment of liver status in patients who are at increased risk of complications from a liver biopsy.

  Contraindications
  HCV FibroSURE is not recommended for patients during combined interferon/ribavirin therapy, since ribavirin may induce hemolysis, low haptoglobin levels, and falsely elevated fibrosis and activity scores. HCV FibroSURE should not be used for patients with Gilbert disease, acute hemolysis, acute viral hepatitis, drug-induced hepatitis, genetic liver disease, autoimmune hepatitis, and/or extrahepatic cholestasis. Any of these clinical situations may lead to inaccurate quantitative predictions of fibrosis.

• Reference Range:
  

  Alanine aminotransferase (ALT)
  Male: 0-55 IU/L
  Female: 0-40 IU/L

  Alpha-2-macroglobulin
  110-276 mg/dL

  Apolipoprotein A-1
  Male: 110-180 mg/dL
  Female: 110-205 mg/dL

  Bilirubin, total
  0.1-1.2 mg/dL

  Gamma glutamyl transferase (GGT)
  Male: 0-65 IU/L
  Female: 0-60 IU/L

  Haptoglobin
  34-200 mg/dL

  Metavir Scoring System

  Fibrosis Stage (FibroTest)
  	F0 - No fibrosis F0 - F1 F1 - Portal fibrosis F1 - F2 F2 - Bridging fibrosis with few septa F3 - Bridging fibrosis with many septa   F3 - F4 F4 - Cirrhosis	< 0.21 0.21 - 0.27 0.27 - 0.31 0.31 - 0.48 0.48 - 0.58 0.58 - 0.72 0.72 - 0.74 > 0.74
  Activity Grade (ActiTest)
  	A0 - No activity A0 - A1 A1 - Minimal activity A1 - A2 A2 - Moderate activity A2 - A3 A3 - Severe activity	< 0.17 0.17 - 0.29 0.29 - 0.36 0.36 - 0.52 0.52 - 0.60 0.60 - 0.62 > 0.62

• Additional Test Info:
  

  The performance characteristics of this test have been determined by LabCorp. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not currently required. LabCorp is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and is certified to perform high complexity testing.

  This test is referred through Quest Diagnostics Nichols Institute.

• Day Run:
  Mon-Fri
• Time Reported:
  Within 8 days
• Test Type:
  CHEMISTRY