Hepatitis C Virus (HCV) FibroSure®
Also known as: ActiTest, FibroSure®, FibroTest
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. Patient should be fasting for at least eight hours prior to sample collection. For inquiries about the test, customer service can be contacted at 1-800-788-9223. Physicians can contact the lab directly at 800-222-7566. Specimens 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.
Limitations
The FibroSure® test was developed by LabCorp, and its performance characteristics were determined by LabCorp. It has not been cleared or approved by the FDA, as the FDA determined that such clearance or approval is not necessary. This test is not recommended for patients with Gilbert Disease, acute hemolysis, acute hepatitis of the liver, extra-hepatic cholestasis, transplant patients, or renal insufficiency patients due to possible inaccurate quantitative predictions.
Methodology
Other
Biomarkers
LOINC Codes
- 48796-7
- 48795-9
- 48794-2
- 48792-6
- 48793-4
- 62364-5
- 1835-8
- 4542-7
- 1869-7
- 1975-2
- 2324-2
- 1743-4
- 8262-8
- 8264-4
- 8266-9
- 8251-1
- 77202-0
Result Turnaround Time
3-5 days
Related Documents
For more information, please review the documents below
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.
Patient Preparation
Patient should be fasting for at least eight hours.
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.
Causes for Rejection
Gross hemolysis; gross lipemia; improper labeling; nonfasting specimen; patient younger than 14 years of age
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 72 hours |
| Refrigerated | 72 hours |
| Frozen | 7 days |