For in vitro diagnostic use. Others Resistance Plus MG IVD ResistancePlus® MG RMD-Speedx-001 Multiplex real-time PCR assay for the identification of Mycoplasma genitalium and detection of mutations associated with resistance to azithromycin 09 257 233 001 9 257 233 001 09257233001 9257233001 09257233001 ResistancePlus MG ResistancePlus MG 07613336207932 Reagents, kits 100 tests Not Available true The ResistancePlus® MG kit simultaneously detects M. genitalium and 5 mutations at positions 2058 and 2059 in the 23S rRNA gene (E. coli numbering) that are associated with resistance to azithromycin (macrolide-based antibiotic).The ResistancePlus® MG kit is a 1-wellreal-timePCR multiplex consisting of 3 readouts. Readout 1 indicates the presence or absence of M. genitalium through detection of the MgPa gene; Readout 2 indicates the presence of a A2058G, A2059G, A2058T, A2058C or A2059C mutation in the 23S rRNA gene; and Readout 3 is an internal control to monitor extraction efficiency and qPCR inhibition. The ResistancePlus® MG kit utilises PlexZyme® and PlexPrime® for specificity and superior multiplexing capability.The assay is validated onsamples extracted using the MagNA Pure 96 System (Roche), MICROLAB STARlet IVD (Hamilton), NUCLISENS® easyMAG® (Biomérieux) and real-time detection on the Roche LightCycler® 480 Instrument II (LC480 II) andcobas z 480 analyser (z480). en The ResistancePlus® MG kit is a qualitative multiplexed in vitro diagnostic real-time PCR test for the identification of M. genitalium and detection of 5 mutations in the 23S rRNA gene (A2058G, A2059G, A2058T, A2058C, and A2059C, Escherichia coli numbering) that are associated with resistance to azithromycin (macrolide antibiotic). It is intended to aid in the diagnosis of M. genitalium and detects mutations associated with azithromycin resistance in M. genitalium and should be used in conjunction with clinical and other laboratory information.The ResistancePlus® MG kit may be used with the following specimen types: male and female urine, and anal, rectal, cervical, endocervical, vaginal, urethral, penile, penile meatal and pharyngeal swabs, from symptomatic and asymptomatic patients.Negative results do not preclude M. genitalium infections and do not provide confirmation of azithromycin susceptibility as there may be other mechanisms of treatment failure.The ResistancePlus® MG 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^® MG

Multiplex real-time PCR assay for the identification of Mycoplasma genitalium and detection of mutations associated with resistance to azithromycin

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ResistancePlus^® MG

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