1. Intended Use
HBV quantitative and YMDD mutation real time PCR kit is used for the detection of HBV YMDD
mutation in serum or plasma by using the real time PCR systems.
2. Product Description
Hepatitis B virus (HBV) is one of the most common infectious diseases in the world. More than 300
million people worldwide are estimated to have chronic HBV infection. Ten percent of these patients
will die as a direct consequence of persistent viral infection. Nucleoside analogue therapy allows safe,
long-term suppression of HBV and is a major milestone in the treatment of chronic hepatitis B.
Lamivudine, the first of these agents approved worldwide, effectively suppresses viral replication,
reduces disease activity, improves liver histology, and delays clinical progression. However, the
development of lamivudine resistant mutations occurs in 14%-32% of patients after 1 year of therapy.
The longer the treatment is continued, the more frequently resistance is seen (65% at 5 years).
Therefore, it is necessary to monitor chronic hepatitis B patients before and during lamivudine
HBV quantitative and YMDD mutation real time PCR kit contains a specific ready-to-use system for
the detection of HBV and HBV YMDD in one reaction using PCR (polymerase chain reaction) in the
real-time PCR system. The master contains reagents and enzymes for the specific amplification of
HBV DNA and HBV YMDD DNA fragment. Fluorescence is emitted and measured by the real time
systems´ optical unit during PCR. The detection of amplified HBV DNA fragment for YMDD
mutation is performed in fluorimeter channel FAM with the fluorescent quencher BHQ1. DNA
extraction buffer is available in the kit. In addition, an external HBV-YMDD positive control
(1×107IU/ml) is contained in the kit to allow the determination of the gene load. For further
information, please refer to section 9.2 Quantitation.