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HPV 16&18 Real Time PCR Kit *CE Marked


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1. Intended Use
HPV 16&18 real time PCR kit is used for the detection of HPV 16&18 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. Two types of genital tract HPV
in particular, HPV 16 and HPV 18, are known to cause up to 95% of cervical cancers, and new studies
show that they may be linked to oral cancer as well. Both of these are genital viruses which are spread
through sexual contact. HPV 16&18 real time PCR kit contains a specific ready-to-use system for the
detection of HPV 16&18 by polymerase chain reaction in the real-time PCR system. The master
contains reagents and enzymes for the specific amplification of HPV 16&18 DNA. Fluorescence is
emitted and measured by the real time systems´ optical unit during PCR. The detection of amplified
HPV 16&18 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 DNA
extraction. 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(1×107copies/ml)
contained, allows the determination of the gene load. For further information, please refer to section 9.3

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