Hepatitis C Virus (HCV) FibroSure®

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Category:

Turnaround Time: 3 - 5 days
CPT Code:

81596

Test Type: 3.5 mL Serum
Stability Time:

Specimen can be stored refrigerated at 2°C to 8°C for 72 hours and frozen at -70°C for seven days. Frozen samples are stable for one freeze/thaw cycle.

Reference Range:

METAVIR Group Scoring System

Fibrosis Stage (FibroTest)

Range

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 Stage (ActiTest)

Range

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

>0.60−0.63

A3−Severe activity

>0.63−1.00

Overview:

Assessment of liver status following a diagnosis of HCV. Baseline determination of liver status before initiating HCVtherapy. Posttreatment 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.

This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the US Food and Drug Administration(FDA). The FDA has determined that such clearance or approval is not necessary.

Bedossa P, Dargère D, Paradis V. Sampling variability of liver fibrosis in chronic hepatitis C. Hepatol. 2003 Dec; 38(6):1449-1457. PubMed 14647056

Clark PJ, Patel K. Noninvasive tools to assess liver disease.Curr Opin Gastroenterol. 2011 May; 27(3):210-216. PubMed 21248634

Halfon P, Bourliere M, Deydier R, et al. Independent prospective multicenter validation of biochemical markers (fibrotest-actitest) for the prediction of liver fibrosis and activity in patients with chronic hepatitis C: The fibropaca study. Am J Gastroenterol. 2006 Mar; 101(3):547-555. PubMed 16542291

Poynard T, Imbert-Bismut F, Munteanu M, et al. Overview of the diagnostic value of biochemical markers of liver fibrosis (FibroTest, HCV FibroSure) and necrosis (ActiTest) in patients with chronic hepatitis C. Comp Hepatol. 2004 Sep 23; 3(1):8-19. PubMed 15387887

Poynard T, Munteanu M, Imbert-Bismut F, et al. Prospective analysis of discordant results between biochemical markers and biopsy in patients with chronic hepatitis C. Clin Chem. 2004 Aug; 50(8):1344-1355. PubMed 15192028

Collection Details:

Patient Preparation:

Patient should be fasting for at least eight hours.

Collection Instructions:

The patient's age and gender must be included on the test request form.

Red-top tube or gel-barrier tube.

Separate serum from cells within two hours of collection.

Specimen can be stored refrigerated at 2°C to 8°C for 72 hours and frozen at -70°C for seven days. Frozen samples are stable for one freeze/thaw cycle.