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.1 Today, 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.

Resistance
Plus
® 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
Channel and target table, NG

 

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

In development

 

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.