Hepatitis C Virus (HCV) by Quantitative NAAT with Reflex to HCV High-Resolution Genotype by Sequencing

Casandra

Casandra Test Code AR87423Version 1 (DRAFT)

Performing Lab

Lab ARUP LaboratoriesLab Test ID 3000577CPT Codes 87522, 87902

Hepatitis C Virus (HCV) by Quantitative NAAT with Reflex to HCV High-Resolution Genotype by Sequencing

Also known as: HCVQT HGR

Clinical Use

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Use

This test is used to confirm active HCV infection following a positive HCV screen and reflexes to genotype determination to aid in prognosis and treatment selection, particularly when a high level of subtype resolution is required. It is intended for diagnosis and management of HCV infection in individuals with antibody evidence of HCV, those suspected of active infection, or those at risk of infection. This assay aids in monitoring antiviral therapy by measuring HCV RNA levels at baseline, during treatment, and at treatment completion to assess viral response.

Special Instructions

Specimens must be separated from cells within 24 hours of collection and transferred to an ARUP standard transport tube. The preferred sample types include lavender or pink (K2EDTA) tubes, plasma preparation tubes, or serum separator tubes. Specimens should be shipped frozen.

Limitations

The quantitative range of this test is 15-100,000,000 IU/mL. A 'Not Detected' result does not exclude the presence of inhibitors or HCV RNA below detection levels. Single viral load determinations should be interpreted with caution. This test is not intended for blood donor screening, associated reentry protocols, or screening of human cells or tissues. It is performed in a CLIA-certified laboratory but has not been cleared by the FDA.

Test Details

New York Approved