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Hepatitis C Fibrosure
|Approval req'd?||Yes, if not ordered by GI service or Hepatologist|
|Test group||Hepatitis C|
|Performed by||LabCorp via Quest|
|Patient Preparation||Patient should fast for at least 8 hours prior to sample collection.|
|Collection Instructions||Deliver sample to laboratory immediately after collection.|
|Container type||Gold top or Red top|
|Amount to Collect||7 mL blood|
|Preferred volume||3 mL serum|
|Min. Volume||3 mL serum|
|Processing notes||Separate serum from cells within 1 hour of collection. Freeze serum at -20C. Order Quest test # 17611X.
For Brown & Toland patients, order LabCorp test # 550123.
|Units||See individual tests|
|Normal range|| Reference ranges for individual tests:
Alanine aminotransferase (ALT)
Newborns term and near term:
Gamma glutamyl transpeptidase (GGT)
Fibrosis stage (Fibro test):
Activity grade (ActiTest):
|Stability||Refrigerated 3 days, frozen at -20C 4 months|
|Turn around times||Performed 5x per week. Turnaround 4-8 days|
|Additional information|| Quantitative results of 6 biochemical tests are analyzed using a computational algorithm to provide a quantitative surrogate marker (0.0-1.0) for liver fibrosis (METAVIR F0-F4) and for necroinflammatory activity (METAVIR A0-A3).
Necroinflamm Activity Scoring:
The negative predictive value of a Fibrotest score <0.31 (absence of clinically significant fibrosis) was 85% when compared to liver biopsy in 1,270 HCV infected patients with a 38% prevalence of significant liver fibrosis (F2, 3 or 4). The positive predictive value of a Fibrotest score >0.48 (F2, 3, 4) was 61% in that same patient cohort.
HCV FibroSURE is not recommended in patients with Gilbert Disease, acute hemolysis (e.g. HCV ribavirin therapy mediated hemolysis) acute hepatitis of the liver, extra-hepatic cholestasis, transplant patients, and/or renal insufficiency patients. Any of these clinical situations may lead to inaccurate quantitative predictions of fibrosis and necroinflammatory activity in the liver.
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.
|Last Updated||3/26/2013 1:55:34 PM|