For in vitro diagnostic use. Others Resistance Plus GC IVD ResistancePlus® GC RMD-Speedx-002 Multiplex real-time PCR assay for the detection of Neisseria gonorrhoeae and markers associated with susceptibility and resistance to ciprofloxacin 09 257 241 001 9 257 241 001 09257241001 9257241001 09257241001 ResistancePlus GC ResistancePlus GC 07613336207949 Reagents, kits 100 tests Not Available true The ResistancePlus® GC kit simultaneously detects the bacterium Neisseria gonorrhoeae (GC) and the gyrA S91 (wild type) or gyrA S91F (mutant) markers that are associated with susceptibility or resistance to the fluoroquinolone antibiotic, ciprofloxacin.The ResistancePlus® GC kitis a 1-wellreal-timePCR multiplex consisting of 5 readouts: Readout 1) GC opa gene, Readout 2) GC porA gene, Readout 3) gyrA S91 (wild type), Readout 4) gyrA S91F (mutant), and Readout 5) Internal control (to monitor extraction efficiency and PCR inhibition). The ResistancePlus® MG kit utilises PlexZyme® and PlexPrime® for specificity and superior multiplexing capability.The assay is compatible with samples extracted using the MagNA Pure 96 System (Roche), EZ1 Advanced XL (Qiagen), QIAsymphony® SP (QIAGEN) and real-time detection on the LightCycler® 480 Instrument II (LC480 II, Roche), cobas z 480 analyser (z 480). en The ResistancePlus® GC kit is a qualitative real-time PCR assay for the detection of Neisseria gonorrhoeae and gyrA S91 wild type and gyrA S91F mutantDNA markers that are associated with susceptibility or resistance to ciprofloxacin.The ResistancePlus® GC kit is intended to aid in the diagnosis of Neisseria gonorrhoeae and gyrA status andshould be used in conjunction with clinical and other laboratory information.The ResistancePlus® GC kit may be used with the following specimen types: male and female urine, and anal, rectal, cervical, endocervical, vaginal, urethral, pharyngeal and eye swabs, from symptomatic and asymptomatic patients.The ResistancePlus® GC kit is intended to be used in professional settings such as hospitals, or reference or state laboratories. It is not intended for self-testing, home use, or point of care use. en Real-time PCR (qPCR) can be used to amplify and detect specific target nucleic acids from pathogens. Plex PCR®is a qPCR technology utilising PlexZyme® enzymes that detect and report the amplified product through the generation of a fluorescent signal ( Figure 1). Plex Prime® primers for specific amplification of mutant sequences which is coupled with mutant specific PlexZyme® detection ( Figure 2).PlexZyme® enzymes are catalytic DNA complexes composed of two DNA oligos referred to as “Partial Enzymes”. Each Partial Enzyme has a target-specific region, a catalytic core and a universal probe binding region. When the target product is present, the two Partial Enzymes bind adjacently to form the active PlexZyme® which has catalytic activity to cleave a labelled probe. Cleavage separates the fluorophore and quencher dyes, producing a fluorescent signal that can be monitored in real time. PlexZyme® enzymes have additional specificity compared to alternate detection technologies, since two Partial Enzymes are required to bind for detection. PlexZyme® enzymes are also multiple turnover enzymes, and multiple probes can be cleaved during each PCR cycle, resulting in a strong and sensitive signal. PlexZyme® assays are highly sensitive and specific and are ideally suited for the multiplexed detection of pathogens.Plex Prime® primershave three functional regions. The long 5’ region anchors the primer to a particular location, and the short 3’ region selectively targets extension from the mutant base. An Insert sequence lies between the 5’ and 3’ regions and acts as a bridging structure which inserts atarget-independent sequence into the resulting amplicon and increases the selective pressure of the 3’ region. In multiplex, each Plex Prime® primer is designed to target a specific mutant base and will incorporate a unique Insert sequence, thus producing distinct mutant amplicon sequences. Unlike other probe-based detection technologies, the PlexZyme® enzyme can be overlapped with the Plex Prime® primer to target the specific mutant amplicon containing the mutant base and incorporated Insert sequence. The unique combination of Plex Prime® primers coupled to PlexZyme® enzymes allows the specific amplification of mutant sequences, and sensitive and specific detection in multipllex. en

ResistancePlus^® GC

Multiplex real-time PCR assay for the detection of Neisseria gonorrhoeae and markers associated with susceptibility and resistance to ciprofloxacin

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