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SPD SCIENTIFIC PTE LTD
Class D IVD
The HCV VL Assay, performed on GeneXpert® Instrument Systems, is designed for the rapid quantitation of Hepatitis C Virus (HCV) RNA in human serum or plasma (EDTA) from HCV-infected individuals. The test utilizes automated reverse transcriptase polymerase chain reaction (RT-PCR) using fluorescence to detect the RNA of interest for the quantitation of HCV. The HCV VL Assay quantifies HCV genotypes 1–6 over the range of 10 to 100,000,000 IU/mL.The HCV VL Assay is intended for use as an aid in the management of HCV infected patients undergoing antiviral therapy. The test measures HCV RNA levels at baseline and during treatment and can be utilized to predict sustained and nonsustained virological responses to HCV therapy. Results from the HCV VL Assay may also be used to confirm HCV infection in anti-HCV positive individuals. The assay is not intended to be used as a donor screening test for HCV.