This diagnostic kit is an in vitro nucleic acid amplification test for the quantification of Human Hepatitis B Virus (HBV) DNA in human serum. It is intended for use as an aid in diagnosing an HBV infection and observing drug efficacy. Test results should not be taken as the only indicator for illness evaluation. Clinical symptoms should also be considered. This test can not be applied for blood screening.
The diagnostic kit uses magnetic-bead technology to extract HBV-DNA from clinical serum or plasma. By applying real-time fluorescence quantitative PCR technology, this test utilizes a pair of specific primers (PCR) which are designed to target at a conserved sequence of HBV-DNA, a specific fluorescence probe (TaqMan probe is labeled with FAM at the 5’ end), accompanied with PCR mix,to achieve quantitative detection of HBV-DNA through fluorescent signal changes.
The PCR detection system uses an internal positive control (TaqMan probe of HBV internal control is labeled with HEX at the 5’ end ) 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 PCR negative result. This diagnostic kit uses UNG enzyme + dUTP system to remove carry-over contamination. When specimens are pretreated at 50°C before PCR amplification, the UNG enzyme shall degrade possible unwanted PCR side products sufficiently to avoid a false positive result.
The PCR detection system uses ROX reference dye to eliminate variations occurring in specimen adding and existing among different tubes, as well as to facilitate the instrument’s automatic analysis of the ratio between reported fluorescence and the internal reference fluorescence (ROX), achieving more accurate quantification.
CFDA Marked, CE Pending