Hepatitis C Virus (HCV) FibroSure®

CPT: 81596
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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



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.


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

Temperature

Period

Room temperature

72 hours (stability provided by manufacturer or literature reference)

Refrigerated

72 hours (stability provided by manufacturer or literature reference)

Frozen

7 days (stability provided by manufacturer or literature reference)

Freeze/thaw cycles

Stable 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 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


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

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
550123 HCV FibroSure 48796-7 550102 Fibrosis Score 48795-9
550123 HCV FibroSure 48796-7 550132 Fibrosis Stage 48794-2
550123 HCV FibroSure 48796-7 550103 Necroinflammat Activity Score 48792-6
550123 HCV FibroSure 48796-7 550133 Necroinflammat Activity Grade 48793-4
550123 HCV FibroSure 48796-7 550398 Methodology: 62364-5
550123 HCV FibroSure 48796-7 122137 Alpha 2-Macroglobulins, Qn mg/dL 1835-8
550123 HCV FibroSure 48796-7 001629 Haptoglobin mg/dL 4542-7
550123 HCV FibroSure 48796-7 016874 Apolipoprotein A-1 mg/dL 1869-7
550123 HCV FibroSure 48796-7 001100 Bilirubin, Total mg/dL 1975-2
550123 HCV FibroSure 48796-7 001960 GGT IU/L 2324-2
550123 HCV FibroSure 48796-7 001547 ALT (SGPT) P5P IU/L 1743-4
550123 HCV FibroSure 48796-7 550106 Interpretations: N/A
550123 HCV FibroSure 48796-7 550107 Fibrosis Scoring: N/A
550123 HCV FibroSure 48796-7 550121 Necroinflamm Activity Scoring: N/A
550123 HCV FibroSure 48796-7 550105 Limitations: 8251-1
550123 HCV FibroSure 48796-7 550127 Comment: 77202-0
550123 HCV FibroSure 48796-7 123094 Comment: 77202-0

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