This test is intended for use as an aid in the management of HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and non-sustained virological response to HCV therapy. The results from this test must be interpreted within the context of all relevant clinical and laboratory findings.
The Panther HCV test is an FDA approved in vitro nucleic acid amplification test. It provides Real-Time PCR HCV viral load results in human plasma from 1 IU/mL to 100,000,000 IU/mL. The test also has been validated for qualitative detection of HCV RNA down to 1 IU/mL across all six genotypes. One International Unit (IU) is equivalent to approximately 2.7 copies of HCV RNA.