Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR, Serum

Casandra

Casandra Test Code MC16687Version 1 (DRAFT)

Performing Lab

Lab Mayo Clinic LabLab Test ID HCVQNCPT Code 87522

Hepatitis C Virus (HCV) RNA Detection and Quantification by Real-Time Reverse Transcription-PCR, Serum

Clinical Use

Use

This test is crucial for detecting acute hepatitis C virus (HCV) infection before the appearance of HCV antibodies in serum and for confirming chronic HCV infections. It provides quantification of HCV RNA levels, essential for monitoring disease progression in chronic HCV infection and assessing response to antiviral therapy. The test also helps determine cure and detect relapse after completion of therapy. It acts as a baseline for HCV viral load before starting antiviral treatment, making it integral for therapeutic monitoring and determining sustained virologic response.

Special Instructions

A reflex test is implemented for serum specimens that are HCV antibody screen-reactive. This test is appropriate for high-risk or immunosuppressed individuals who may be HCV antibody negative but require a diagnosis of acute hepatitis C. It should be used to establish a baseline HCV viral load for monitoring treatment progress and detecting relapse post-therapy.

Limitations

The test can't accurately quantify HCV RNA levels below 15 IU/mL due to the lower detection limit of the assay. False-negative results may occur in cases of transient viremia or in the presence of inhibitory substances in the submitted specimen. Subsequent testing with new specimen collection may be required if the result is inconclusive.

Test Details

FDA Approved