1. Intended Use
Neisseria Gonorrhoeae real time PCR kit is used for the detection of neisseria gonorrhoeae in
genital swabs or urine by using real time PCR systems.
2. Product Description
Gonorrhea is a sexually transmitted disease (STD). It is caused by Neisseria gonorrhoeae, a
bacterium that can grow and multiply easily in the warm, moist areas of the reproductive tract,
including the cervix, uterus, and fallopian tubes in women, and in the urethra in women and men.
Neisseria gonorrhoeae real time PCR kit contains a specific ready-to-use system for the detection
of neisseria gonorrhoeae by polymerase chain reaction (PCR) in the real-time PCR system. The
master contains reagents and enzymes for the specific amplification of neisseria gonorrhoeae DNA.
Fluorescence is emitted and measured by the real time systems´ optical unit during PCR. The
detection of amplified neisseria gonorrhoeae 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 internal control (IC). An
external positive control (1×107copies/ml) allows the determination of the gene load. For further
information, please refer to section 9.3 Quantitation.