The study objective is to evaluate the clinical utility of the DxN HCV assay as an aid in the management of patients chronically infected with hepatitis C and undergoing antiviral therapy.
Negative predictive value (NPV) and positive predictive value (PPV) for achieving a sustained viral response (SVR), and odd ratios of an association between viral loads during treatment and SVR, will be calculated based on achievement of rapid viral response (RVR) at week 4 of therapy, early viral response (EVR) at week 12 of therapy, and extended rapid viral response (eRVR) based on type of therapy as defined in section 6.
Concordance in virologic response, including RVR, EVR, eRVR, treatment futility, and SVR between the DxN HCV assay and the viral load assay that is the standard of care at the institution will also be calculated.
Proposed Intended Use and Indications for Use
Proposed Intended Use
The DxN Hepatitis C virus (HCV) assay is an in vitro nucleic acid amplification real-time polymerase chain reaction (PCR) assay for the quantitative determination of HCV nucleic acid in human K2EDTA plasma and serum of HCV-infected individuals using the DxN instrument for automated sample processing, amplification and detection. Specimens containing HCV genotypes 1 – 6 have been validated for quantitation in the assay.
Proposed Indications for Use
The DxN HCV assay is intended for use as an aid in the management of HCV-infected individuals undergoing antiviral therapy. The assay measures HCV RNA levels at baseline and during treatment and can be used to predict sustained and non-sustained virologic response to HCV therapy. The results from the DxN HCV assay must be interpreted within the context of all relevant clinical and laboratory findings.
This assay is not intended for use as a screening test for the presence of HCV in blood or blood products or as a diagnostic test to confirm the presence of HCV infection.
Principal Investigator: Juan Gallegos-Orozco