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CPT:
[MAAA: 0002M] or 82172; 82247; 82465; 82947; 82977; 83010; 83883; 84450; 84460; 84478
Synonyms
- Alcoholic Liver Disease
- Noninvasive Liver Biopsy
- Steatohepatitis
Special Instructions
The patient's age, gender, height, and weight at the time of collection must be submitted for FibroSure® testing.
Expected Turnaround Time
3 - 6 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 Information
Related Documents
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
This test is intended for noninvasive assessment of liver status in patients with alcoholic liver disease. Quantitative results of 10 biochemicals in combination with age, gender, height, and weight are analyzed using a computational algorithm to provide a quantitative surrogate marker (0.0-1.0) of liver fibrosis (Metavir F0-F4), hepatic steatosis (0.0-1.0, S0-S3), and alcoholic steatohepatitis (ASH) (0.0-1.0, H0-H3).
Limitations
ASH FibroSure® is recommended for patients with suspected alcoholic liver disease. It is not recommended for patients with other liver diseases. It is also not recommended in patients with Gilbert disease, acute hemolysis, acute hepatitis, acute inflammation of the liver, extrahepatic cholestasis, transplant patients, and/or renal insufficiency patients. Any of these clinical situations may lead to inaccurate quantitative predictions of fibrosis.
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.
References
Naveau S, Raynard B, Ratziu V, et al. Biomarkers for the prediction of liver fibrosis in patients with chronic alcoholic liver disease. Clin Gastroenterol Hepatol. 2005 Feb; 3(2):167-174. 15704051
Poynard T, Ratziu V, Naveau S, et al. The diagnostic value of biomarkers (SteatoTest) for the prediction of liver steatosis. Comp Hepatol. 2005 Dec 23; 4:10. 16375767
Thabut D, Naveau S, Charlotte F, et al. The diagnostic value of biomarkers (AshTest) for the prediction of alcoholic steatohepatitis in patients with chronic alcoholic liver disease. J Hepatol. 2006 Jun; 44(6):1175-1185. 16580087
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