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Test ID: FHFIB    
Hepatitis C Virus (HCV) FibroSURE

Useful For Suggests clinical disorders or settings where the test may be helpful

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. Non-invasive assessment of liver status in patient

who are at increased risk of complications from a liver biopsy.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

TESTS

REFERENCE INTERVAL

HCV FibroSURE Results:

 

Fibrosis Score

0.00 – 0.21

Fibrosis Stage

 

Necroinflammat Activity Score

0.00 – 0.17

Necroinflammat Activity Grade

 

 

Analysis:

Alpha-2-Macroglobins, QN

 

110 – 276

mg/dL

Haptoglobin

 

34 – 200

mg/dL

Apolipotprotein A-1

Females:

110 – 205

mg/dL

 

Males:

110 – 180

mg/dL

Bilirubin, Total

 

0.0 – 1.2

mg/dL

GGT

Females:

0 – 60

IU/L

 

Males:

0 – 65

IU/L

ALT (SPGT)

Females:

0 – 40

IU/L

 

Males:

0 – 55

IU/L

 

Interpretations:

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

Limitations:
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.

 

Test Performed by:       Lab-Corp Burlington

                                    1447 York Court

                                    Burlington, NC 57215-2230