Liver Fibrosis - FibroMeter Vibration Controlled Transient Elastography (FibroMeter plus FibroScan VCTE)
Noninvasive assessment of liver fibrosis in patients with chronic viral hepatitis B or C (with or without HIV coinfection) and in patients with hepatic steatosis. Test can be performed only if the patient has a FibroScan score. Result based on both a panel of serum biomarkers (FibroMeter) and the FibroScan Vibration Controlled Transient Elastography (VCTE), a noninvasive, diagnostic ultrasound-based test that measures liver fibrosis.
Quantitative Nephelometry/Quantitative Enzymatic/Quantitative Spectrophotometry/Automated Cell Count/Electromagnetic Mechanical Clot Detection/Vibration Controlled Transient Elastography
Patient must be 18 years of age or older. Platelet count should be performed on the EDTA whole blood sample at the client site within 3 days of submission for testing.
Lavender (K2EDTA) or Pink (K2EDTA) AND Serum Separator Tube (SST) AND Light Blue (Sodium Citrate).
Separate from cells ASAP or within 2 hours of collection. Transport 3 mL serum in an ARUP Standard Transport Tube. (Min: 1.2 mL) AND Transport 1 mL platelet-poor citrated plasma in an ARUP Standard Transport Tube. (Min: 0.5 mL) Do not send the EDTA whole blood to ARUP.
Plasma (citrated): CRITICAL FROZEN. Separate specimens must be submitted when multiple tests are ordered.
All required specimens not received. No platelet count received. VCTE performance date greater than 6 months from the specimen draw date and time. Hemolyzed specimens.
Include an automated platelet count. The Liver Stiffness result (in kPa) from the Fibroscan VCTE must be submitted with the samples. The performance date of the VCTE must also be submitted.
Serum: Ambient: 8 hours; Refrigerated: 1 week; Frozen: 2 weeks
Plasma: Ambient: 24 hours; Refrigerated: Unacceptable; Frozen: 2 weeks
Refer to report.
Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
Delays in test performance may result if the VCTE result and date of performance is not included with the requisition.
83883; 84450; 82977 (Alt code: 81599)
|Component Test Code*||Component Chart Name||LOINC|
|2005664||FibroMeter Platelet Count||26515-7|
|2005666||Fibrometer Prothrombin Index||6302-4|
|2010928||Aspartate Aminotransferase, FibroMeter||1920-8|
|2010930||Gamma Glutamyl Transferase, FibroMeter||2324-2|
|3001380||EER Fibrometer VCTE Report||11526-1|
|3001381||FibroMeter VCTE Metavir Classification||48794-2|
|3001382||FibroMeter VCTE Interpretation||48767-8|
|3001383||FibroScan VCTE Liver Stiffness||77615-3|
|3001384||FibroMeter VCTE Score||77616-1|