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Hepatitis C Fibrosure

Item Value
Approval req'd? Yes, if not ordered by GI service or Hepatologist
Available Stat? No
Test code HCVF
Test group Hepatitis C
Performed by LabCorp via Quest
Sendout? Yes
Method Multiple tests
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
Sample type Serum
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)
Male 0-55 IU/L
Female 0-40 IU/L

A2-macroglobulin 110-276 mg/dL

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

Bilirubin, total
Newborns term and near term:
24 hours old 0.0-8.0 mg.dL
48 hours old 0.0-13.2 mg/dL
72 hours old 0.0-15.6 mg/dL
96 hours old 0.0-16.6 mg/dL
≥ 1 month old 0.0-1.2 mg/dL
Adults 0.0-1.2 mg/dL

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

Haptoglobin 34-200 mg/dL

Metavir scale:
Fibrosis stage (Fibro test):
F0 - no fibrosis 0.00-0.21
F0-F1 0.21-0.27
F1 - portal fibrosis 0.27-0.31
F1-F2 0.31-0.48
F2 - bridging fibrosis with few septa 0.48-0.58
F3 - bridging fibrosis with many septa 0.58-0.72
F3-F4 0.72-0.74
F4 - cirrhosis 0.74 - 1.00

Activity grade (ActiTest):
A0 - no activity 0.00-0.17
A0-A1 0.17-0.29
A1 - minimal activity 0.29-0.36
A1-A2 0.36-0.52
A2 - moderate activity 0.52-0.60
A2-A3 0.60-0.62
A3 - severe activity 0.62-1.00
Synonyms HCV fibrosure
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).

Fibrosis Scoring:
<0.21 Stage F0 - No fibrosis
0.21 - 0.27 Stage F0 - F1
0.27 - 0.31 Stage F1 - Portal fibrosis
0.31 - 0.48 Stage F1 - F2
0.48 - 0.58 Stage F2 - Bridging fibrosis with few septa
0.58 - 0.72 Stage F3 - Bridging fibrosis with many septa
0.72 - 0.74 Stage F3 - F4
>0.74 Stage F4 - Cirrhosis

Necroinflamm Activity Scoring:
<0.17 Grade A0 - No Activity
0.17 - 0.29 Grade A0 - A1
0.29 - 0.36 Grade A1 - Minimal activity
0.36 - 0.52 Grade A1 - A2
0.52 - 0.60 Grade A2 - Moderate activity
0.60 - 0.62 Grade A2 - A3
>0.62 Grade A3 - Severe activity

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.
CPT coding 83883-90,83010-90,82172-90,82247-90,82977-90,84460-90
LOINC code 48796-7
Last Updated 3/26/2013 1:55:34 PM
Entry Number 1193
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