Hepatitis C Virus (HCV) FibroSure®

TEST: 550123
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CPT: 81596
Updated on 11/12/2024
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Synonyms

  • ActiTest
  • FibroSure®
  • FibroTest

Special Instructions

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

Expected Turnaround Time

3 - 5 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Related Documents

For more information, please view the literature below.

Hepatitis C Virus (HCV) FibroSURE®: Noninvasive Assessment of Liver Fibrosis and Necroinflammatory Activity for Patients With Chronic HCV

LabCorp offers the leading HCV menu for complete care decisions

One-time HCV Testing for Baby Boomers

Specimen Requirements

Specimen

Serum

Volume

3.5 mL

Minimum Volume

2 mL

Container

Red-top tube or gel-barrier tube

Collection

Separate serum from cells within two hours of collection, and transfer serum to a transfer tube.

Separate serum from cells within two hours of collection.

Separate serum from cells within two hours of collection, and transfer serum to a transfer tube.

Storage Instructions

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.

Stability Requirements

TemperaturePeriod
Room temperature72 hours (stability provided by manufacturer or literature reference)
Refrigerated72 hours (stability provided by manufacturer or literature reference)
Frozen7 days (stability provided by manufacturer or literature reference)
Freeze/thaw cyclesStable x1 (stability provided by manufacturer or literature reference)

Patient Preparation

Patient should be fasting for at least eight hours.

Causes for Rejection

Gross hemolysis; gross lipemia; improper labeling; nonfasting specimen; patient younger than 14 years of age

Test Details

Use

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

Limitations

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

Methodology

See individual test components.

Reference Interval

See tables.

METAVIR Group Scoring System
Fibrosis Stage (FibroTest)Range
F0−No fibrosis0.00−0.21
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 activity0.00−0.17
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

See tables.

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

See tables.

METAVIR Group Scoring System
Fibrosis Stage (FibroTest)Range
F0−No fibrosis0.00−0.21
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 activity0.00−0.17
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

References

Bedossa P, Dargère D, Paradis V. Sampling variability of liver fibrosis in chronic hepatitis C. Hepatol. 2003 Dec; 38(6):1449-1457. 14647056
Clark PJ, Patel K. Noninvasive tools to assess liver disease.Curr Opin Gastroenterol. 2011 May; 27(3):210-216. 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. 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. 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. 15192028

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