abstract

This diagnostic kit is an in vitro nucleic acid amplification test for the quantification/existence of Human Hepatitis C Virus (HCV) RNA in human serum or plasma. It is intended for use as an aid in diagnosing an HCV infection and observing drug efficacy.

product performance

The diagnostic kit uses magnetic bead technology to extract HCV-RNA in clinical serum or plasma. By applying real-time fluorescence quantitative PCR technology, this test utilizes a pair of specific primers which are designed to target at a conserved sequence of HCV-RNA, a specific fluorescence probe, accompanied with PCR mix,to achieve quantitative detection of HCV RNA through fluorescent signal changes.

The PCR detection system uses an internal control to monitor the presence of PCR inhibitors in test specimens by detecting whether the internal control is normal or not, in order to avoid a false negative result.

The PCR detection system uses ROX reference dye to eliminate variations existing among different tubes and facilitate the instrument’s automatic analysis of the ratio between reported fluorescence and the reference fluorescence (ROX), achieving more accurate quantification/qualification.

CFDA Marked, CE Pending

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