Test ID: FHFIB    
Hepatitis C Virus (HCV) FibroSURE

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.

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-Macroglobulins, Qn                   110 - 276           mg/dL

Haptoglobin                                            34 – 200          mg/dL

Apolipoprotein A-1              Females:     110 – 205          mg/dL

                                          Males:        110 – 180          mg/dL

Bilirubin, Total

                                                     Newborns, term and near term:

                                                        24 hours old:  0.0 –  8.0 mg/dL

                                                        48 hours old:  0.0 – 12.2 mg/dL

                                                        72 hours old:  0.0 – 15.6 mg/dL

                                                        96 hours to 1 month old:  0.0 – 1.2 mg/dL

                                                      Children 1 month and older and

                                                      Adults:  0.0 – 1.2 mg/dL

GGT                                       Females:             0 – 60   IU/L

                                              Males:                 0 – 65   IU/L

ALT (SGPT)                            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

Macroinflamm 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.

Comment:

 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.

Results and Interpretation Provided By:

Lab-Corp RTP

1912 Alexander Drive

Research Triangle Park, NC 27709

Test Performed By:      Lab-Corp Burlington

                                   1447 York Court

                                   Burlington, NC 27215-2230