ResistancePlus^® GC

Unlocking resistance guided therapy for NG

Antimicrobial resistance is on the rise. Neisseria gonorrhea (NG) — also known as Gonococcus (GC) — already developed resistance to multiple classes of antibiotics and is classified as “urgent threat” by the Centers for Disease Control and Prevention.¹Today, advances in testing can enable more accurate treatment, and aims to help healthcare professionals preserve last-line antibiotics for future use.

Through a partnership with SpeeDx, a developer of innovative molecular diagnostic solutions, Roche is ushering in a new era of resistance-focused diagnostics.

Non-empirical treatment strategy for Neisseria gonorrhea using ResistancePlus® GC

Non-empirical treatment workflow

Reflex testing (with resistance profiling) for all non-empirically treated patients, enables more targeted treatment to support the optimal outcome.

Assay design

Leveraging the flexible PlexPrime^® design allows for increased specificity and reduced competition while distinctly different amplicons aid in allele-specific detection in multiplexed format.

ResistancePlus^® GC is a multiplex qPCR test for detection of Neisseria gonorrhoeae and mutations linked with susceptibility or resistance to ciprofloxacin, validated for a range of specimen types.

argeting sequences inside a Neisseria gonorrhea bacterium

Multiplexing capability

Simultaneously detect NG and wild-type/mutant sequences as markers
of susceptibility to ciprofloxacin.

High specificity

Reduce instances of false positives from cross reaction with other
non-gonococcal Neisseria species found in the pharynx.

ResistancePlus® GC sensitivity and specificity performance diagram

ResistancePlus® GC features and benefits

Easy adoption: Fits into any laboratory workflow, providing both detection as well as ciprofloxacin susceptibility in a single test

Improved patient pathway: Delivers rapid resistance data, reducing the need for injectable antibiotics while freeing-up clinical staff

Antimicrobial stewardship: Informs a patient’s treatment pathway, ensuring the most appropriate antimicrobial is used for front-line therapy

Testing compliance: Meets current and emerging International, European and Australian guideline recommendations

Platform compatibility: Validated to work on a number of extraction platforms, with amplification/detection on the LightCycler^® 480 Instrument II and the cobas z 480 Analyzer

Inside PlexPCR^® Technology

PlexZyme^® technology offers high performance and reliable qPCR detection.

During PlexPCR^®, primers amplify target nucleic acid sequences and produce amplicons, which serve as a template for PlexZyme^® formation. Once the partzymes have assembled into PlexZyme^® enzymes, universal probes bind and enzymatic cleavage of the probes between fluorophore and quencher dye pairs generates fluorescence. Changes in fluorescence allow detection and/or quantification of the target nucleic acid in real time.

PlexPrime^® is a novel method for nucleic acid amplification that creates amplicons, which are distinctly different from the parent sequence. The combination of PlexPrime^® and PlexPrime^® technology enables multiplex mutation detection with high sensitivity and specificity.³

Learn more about ResistancePlus® GC

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Intended use

The ResistancePlus^® GC kit is a qualitative real-time PCR assay for the detection of Neisseria gonorrhoeae and the gyrA S91 wild-type and S91F mutant markers that are associated with susceptibility or resistance to ciprofloxacin. The ResistancePlus^® GC kit can be used with the specimen types listed in the Instructions for Use (IFU).

Registration status: CE-IVD, not yet available in the U.S.

References

1. Centers for Disease Control and Prevention. ANTIBIOTIC RESISTANCE THREATS IN THE UNITED STATES.
https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf Accessed March 1, 2020.

2. ResistancePlus^® GC Instructions for Use; IF-IV0009 v4 (March 2020)

3. Tan LY, et al. PLoS One. 2017;12(1):e0170087.

Contact your local Roche Representative for more information by clicking here.

ResistancePlus^® GC kits are developed and manufactured by SpeeDx Pty Ltd, Sydney and distributed by Roche.

LIGHTCYCLER^® and COBAS Z are trademarks of Roche.

PlexPCR^®, PlexZyme^®, PlexPrime^®, and ResistancePlus^® are trademarks of SpeeDx Pty Ltd.