Qualitative Neisseria gonorrhoeae Test Kit - Vietnam Registration 2403716ĐKLH/BYT-HTTB

The GeneProof Neisseria gonorrhoeae PCR Kit uses the principle of real-time PCR to qualitatively detect N. gonorrhoeae based on the amplification of the 16S rRNA gene sequence and the porA pseudogene, which is specific to N. gonorrhoeae, and measures the increase in fluorescence signal. The presence of N. gonorrhoeae is determined by the increase in the FAM fluorescence channel signal. The kit includes an internal control (IS – Internal Standard), which is detected in the HEX fluorescence channel, and is used as a control for both PCR inhibition and the efficiency of nucleic acid purification. The GeneProof Neisseria gonorrhoeae PCR Kit is a certified diagnostic tool for clinical diagnostic equipment, as per the In Vitro Diagnostic Medical Devices Directive 98/97/EC of the European Union, and is designed for specialized use in research and clinical laboratories.