FIB-4 With Reflex to NASH FibroSure® Plus

Casandra

Casandra Test Code LC18305Version 1 (DRAFT)

Performing Lab

Lab LabcorpLab Test ID 402146CPT Code 84450

FIB-4 With Reflex to NASH FibroSure® Plus

Also known as: Fatty Liver Disease, Liver Fibrosis, NAFLD, NASH, Nonalcoholic Fatty Liver Disease

Clinical Use

Order Test

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.

Test Details

Methodology

Other

Biomarkers

2 components

FIB-4 Calculation and Initial TestsNASH FibroSure Plus Reflex

LOINC Codes

Order Codes

98488-0

Result Codes

1920-8
1742-6
777-3
98488-0

Result Turnaround Time

1 day

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.