FIB-4 With Reflex to NASH FibroSure® Plus
Also known as: Fatty Liver Disease, Liver Fibrosis, NAFLD, NASH, Nonalcoholic Fatty Liver Disease
Use
FIB-4 index is reported to be a simple, accurate, non-invasive, and readily available laboratory test index that can help in evaluation of patients with HCV and Non-Alcoholic Fatty Liver Disease (NAFLD) for the presence of liver fibrosis indication for liver biopsy, and other liver-related complications.
Special Instructions
Special instructions include submitting the patient's age and gender, but height and weight are not required for NASH FibroSure® Plus testing. It is vital that the patient's serum is separated from cells within 45 minutes of collection, and whole blood in EDTA tubes should be inverted immediately post-collection to prevent clotting.
Limitations
The test is not recommended for patients with liver conditions other than suspected nonalcoholic fatty liver disease. Specific exclusion criteria include Gilbert disease, acute hemolysis, acute hepatitis, acute inflammation of the liver, autoimmune hepatitis, extrahepatic cholestasis, transplant patients, and renal insufficiency patients, as these conditions could skew results. Clumping may result in false low platelet counts, and satellitism may cause pseudothrombocytopenia. Certain cellular fragments could lead to falsely elevated results in other parts of the assay. The test has not undergone FDA clearance or approval as such processes are deemed unnecessary by the FDA.
Methodology
Other
Biomarkers
LOINC Codes
- 98488-0
- 1920-8
- 1742-6
- 777-3
- 98488-0
Result Turnaround Time
1 day
Related Documents
For more information, please review the documents below
Specimen
Serum
Volume
4 mL
Minimum Volume
3 mL
Container
Gel-barrier tube or red-top tube
Collection Instructions
Separate from cells within 45 minutes of collection.
Patient Preparation
Patient should be fasting for at least eight hours.
Storage Instructions
Serum sample for initial testing and whole blood can be stored room temperature. Serum sample for possible reflex can be stored refrigerated at 2°C to 8°C for 72 hours.
Causes for Rejection
Gross hemolysis; gross lipemia; improper labeling; nonfasting specimen; patient younger than 14 years of age
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 7 days |
| Refrigerated | 14 days |
| Frozen | Unstable |