ASH FibroSURE™

Test Code

900693

CPT Codes
0002M<br>Restricted Client Code

Preferred Specimen

5 mL serum collected in a red-top tube (no gel)

Patient Preparation
Patient should be fasting for at least eight hours

Minimum Volume

3 mL

Instructions

Separate serum from cells within 1 hour of collection. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit separate frozen specimens for each test requested.

Please indicate the patient's age, sex, height, and weight on the test request form.

Transport Temperature

Frozen

Specimen Stability

Room temperature: Unacceptable
Refrigerated: 72 hours
Frozen: 4 months

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Gross hemolysis • Gross lipemia • Improper labeling • Nonfasting specimen

Methodology
Nephelometric • Colorimetric, Kinetic

FDA Status
The performance characteristics of this test have been determined by LabCorp. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not currently required. LabCorp is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and is certified to perform high complexity testing.

Setup Schedule

Monday-Friday Morning
Report available: 7 Days

Reference Range

See Laboratory Report

Clinical Significance

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.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.