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HPV 6&11 Real Time PCR Kit *CE Marked


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1. Intended Use
HPV 6&11 real time PCR kit is used for the detection of HPV 6&11 in genital swabs samples by
using real time PCR systems.

2. Product Description
The human papilloma virus (HPV) is one of the most common virus groups in the world to affect
the skin and mucosal areas of the body. Different types of the HPV’s are known to infect different
parts of the body. Genital warts are known technically as condylomata acuminatum and are
generally associated with two HPV types, numbers 6 and 11 and can be sexually transmitted. HPV
6&11 real time PCR kit contains a specific ready-to-use system for the detection of the HPV 6&11
by polymerase chain reaction in the real-time PCR system. The master contains reagents and
enzymes for the specific amplification of the HPV 6&11 DNA. Fluorescence is emitted and
measured by the real time systems´ optical unit during PCR. The detection of amplified HPV 6&11
DNA fragment is performed in fluorimeter channel FAM with the fluorescent quencher BHQ1.
DNA extraction buffer is available in the kit and genital swabs samples are used for the extraction
of the DNA. In addition, the kit contains a system to identify possible PCR inhibition by measuring
the HEX/VIC/JOE fluorescence of the internal control (IC). An external positive control
(1×107 copies/ml) contained, allow the determination of the gene load. For further information,
please refer to section 9.3 Quantitation.


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