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Currently not for sale in the USA






ResistancePlus® GC


Smarter diagnostics. Simplified patient care.

Detect Neisseria gonorrhoeae and ciprofloxacin susceptibility markers: dual N. gonorrhoeae targets (opa & porA), gyrA S91F mutant, & gyrA S91 wildtype in a single-well multiplex qPCR test

 



Why use ResistancePlus® GC?

Antibiotic resistance in gonorrhoea infections is a global concern. There are limited effective treatment options and novel antibiotics are not readily available. Smarter and more directed use of antibiotics can be achieved through Resistance Guided Therapy.

  • Global surveillance data indicate 50-70% of gonorrhoea infections remain susceptible to ciprofloxacin.

  • Guidelines for gonorrhoea management call to preserve ceftriaxone and recommend use of ciprofloxacin when susceptibility information is available.

  • Azithromycin resistance is rising, compromising dual-therapy options.


Tested on hundreds of clinical samples, ResistancePlus® GC demonstrates excellent sensitivity and specificity.







ResistancePlus® GC workflow solution

Streamline your workflow and increase productivity for rapid, routine diagnostics. Full automation options including sample and qPCR set-up, through to validated software solutions for automated result calling and simple data processing.

  • Validated on a range of specimen types and collection devices

  • Unique triple target solution, ideal for confirming GC positives or for upfront testing with simultaneous resistance status

 

SpeeDx analysis software included in contract pricing is license free and installed on a high security and GDPR compliant platform:

  • audit trails

  • user traceability

  • LIS connectivity

  • QA and batch management


Increase capacity of your existing qPCR instrumentation through universal run conditions compatible with all ResistancePlus® products.




ResistancePlus® GC Performance Specifications

Demonstrated clinical performance — for more detail please see the ResistancePlus® GC Instructions for Use

Performance of ResistancePlus® GC


GC detection

gyrA S91F Detection

Sensitivity

100%

100%

Specificity

99.2%

100%


ResistancePlus® GC 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.





Targets

Single well: N. gonorrhoeae (Opa), N. gonorrhoeae (PorA), Ciprofloxacin resistance, Ciprofloxacin susceptibility, Internal control

 

Sample types

Urine: Male and female

Swabs: anal, rectal, vaginal, and pharyngeal

Pre-extracted samples

 

Amplification instruments

Roche LightCycler® 480 Instrument II (LC480 II)

Thermo Fisher Applied Biosystems® 7500 Fast Real-Time PCR System (7500 Fast)

Thermo Fisher Applied Biosystems® 7500 Fast Dx Real-Time PCR System (7500 Fast Dx)

Bio-Rad CFX96 Dx (CFX96 Dx)

Bio-Rad CFX96 Touch (CFX96 Touch)


Shipping Conditions

Products are shipped on dry ice or ice gel packs.

 

Storage & Stability

Expiry dates are stated on the labels. It is recommended that freeze/thaw cycles be limited to less than 15. Store protected from light at – 25°C to – 15°C.

 

Intended use

For in vitro diagnostic use.

 

Current software

ResistancePlus GC (LC480) v1.0

ResistancePlus GC (7500) v1.0

ResistancePlus GC (CFX) v1.0


Regulatory status

CE-IVD, UKCA, TGA cleared, IVDR Certified





Combating Antimicrobial Resistance (AMR) with ResistancePlus® GC




Antimicrobial Resistance is set to grow 15 times by the year 2050




Specifications

Product Resources

Publications

We are committed to supporting continued scientific discovery and generation of clinically relevant data. Collaborations with key researchers and clinicians around the globe help us improve diagnostics and address urgent clinical needs.


Product

Compatible

Size

Catalog

ResistancePlus® GC

LC480 II

100 reactions

2011001

ResistancePlus® GC

LC480 II

25 reactions

2011025

ResistancePlus® GC

ABI 7500 / ABI 7500 Fast / ABI 7500 Fast Dx

100 reactions

2013001

ResistancePlus® GC

ABI 7500 / ABI 7500 Fast / ABI 7500 Fast Dx

25 reactions

2013025

ResistancePlus® GC

CFX96 Dx / CFX96 Touch

100 reactions

2015001

ResistancePlus® GC

CFX96 Dx / CFX96 Touch

25 reactions

2015025

Accessory Products

ResistancePlus® GC Analysis Software

LC480 II

1 unit

99010

ResistancePlus® GC Analysis Software

ABI 7500 / ABI 7500 Fast / ABI 7500 Fast Dx

1 unit

99009

ResistancePlus® GC Analysis Software

CFX96 Dx / CFX96 Touch

1 unit

99015

LC480 II


2 reactions


90001

All platforms

10 reactions

95003

Validated on instrument. ^Supplied upon request. This kit is only required for initial set-up to establish calibration of PlexPCR® and ResistancePlus® kits on the LC480 instrument, see instruction for use for details.




Ordering Information

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