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Hepatitis C Virus (HCV) FibroSure®

Test Number 550123
Test number copied
CPT

81596
Synonyms
  • ActiTest
  • FibroSure®
  • FibroTest

Test Details

Methodology

See individual test components.

Result 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

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.

Special Instructions

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

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.

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

Specimen Requirements

Specimen

Serum

Volume

3.5 mL

Minimum Volume

2 mL

Container

Red-top tube or gel-barrier tube

Collection Instructions

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

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)

Reference Range

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

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.

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

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
Order Code550123
Order Code NameHCV FibroSure
Order Loinc48796-7
Result Code550102
Result Code NameFibrosis Score
UofM
Result LOINC48795-9
Order Code550123
Order Code NameHCV FibroSure
Order Loinc48796-7
Result Code550132
Result Code NameFibrosis Stage
UofM
Result LOINC48794-2
Order Code550123
Order Code NameHCV FibroSure
Order Loinc48796-7
Result Code550103
Result Code NameNecroinflammat Activity Score
UofM
Result LOINC48792-6
Order Code550123
Order Code NameHCV FibroSure
Order Loinc48796-7
Result Code550133
Result Code NameNecroinflammat Activity Grade
UofM
Result LOINC48793-4
Order Code550123
Order Code NameHCV FibroSure
Order Loinc48796-7
Result Code550398
Result Code NameMethodology:
UofM
Result LOINC62364-5
Order Code550123
Order Code NameHCV FibroSure
Order Loinc48796-7
Result Code122137
Result Code NameAlpha 2-Macroglobulins, Qn
UofMmg/dL
Result LOINC1835-8
Order Code550123
Order Code NameHCV FibroSure
Order Loinc48796-7
Result Code001629
Result Code NameHaptoglobin
UofMmg/dL
Result LOINC4542-7
Order Code550123
Order Code NameHCV FibroSure
Order Loinc48796-7
Result Code016874
Result Code NameApolipoprotein A-1
UofMmg/dL
Result LOINC1869-7
Order Code550123
Order Code NameHCV FibroSure
Order Loinc48796-7
Result Code001100
Result Code NameBilirubin, Total
UofMmg/dL
Result LOINC1975-2
Order Code550123
Order Code NameHCV FibroSure
Order Loinc48796-7
Result Code001960
Result Code NameGGT
UofMIU/L
Result LOINC2324-2
Order Code550123
Order Code NameHCV FibroSure
Order Loinc48796-7
Result Code001547
Result Code NameALT (SGPT) P5P
UofMIU/L
Result LOINC1743-4
Order Code550123
Order Code NameHCV FibroSure
Order Loinc48796-7
Result Code550106
Result Code NameInterpretations:
UofM
Result LOINCN/A
Order Code550123
Order Code NameHCV FibroSure
Order Loinc48796-7
Result Code550107
Result Code NameFibrosis Scoring:
UofM
Result LOINCN/A
Order Code550123
Order Code NameHCV FibroSure
Order Loinc48796-7
Result Code550121
Result Code NameNecroinflamm Activity Scoring:
UofM
Result LOINCN/A
Order Code550123
Order Code NameHCV FibroSure
Order Loinc48796-7
Result Code550105
Result Code NameLimitations:
UofM
Result LOINC8251-1
Order Code550123
Order Code NameHCV FibroSure
Order Loinc48796-7
Result Code550127
Result Code NameComment:
UofM
Result LOINC77202-0
Order Code550123
Order Code NameHCV FibroSure
Order Loinc48796-7
Result Code123094
Result Code NameComment:
UofM
Result LOINC77202-0