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.
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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
| 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.
| 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 |
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See tables.
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See tables.
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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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