ResistancePlus® GC

ResistancePlus® GC

Detect Neisseria gonorrhoeae and ciprofloxacin susceptibility markers

Dual N. gonorrhoeae targets (opaporA), gyrA S91F mutant, & gyrA S91 wildtype in a single-well multiplex qPCR test

 

Smarter diagnostics. Simplified patient care

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.

SpeeDx Resistance Plus GC product box
Scientist using thermocycler

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 96.9% 100%
Specificity 99.7% 98.6%

Specifications

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, cervical, endocervical, vaginal, urethral, pharyngeal, and eye
  • Pre-extracted samples

 

Amplification instruments

  • LightCycler® 480 Instrument II (LC480 II, Roche)
  • Applied Biosystems® 7500 Fast (7500 Fast)
  • Applied Biosystems® 7500 Fast Dx (7500 Fast Dx)
  • Bio-Rad CFX96 IVD (CFX96 IVD)
  • Bio-Rad CFX96 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 – 20°C.

 

Intended use

For in vitro diagnostic use. Not for sale in the USA.

 

Regulatory status

CE-IVD, TGA cleared

Resources

Please contact your local representative if you can’t find what you are looking for.

Safety Data Sheets

 

Current Software Version

  • ResistancePlus® GC (LC480) v1.0
  • ResistancePlus® GC (7500) v1.0
  • ResistancePlus® GC (CFX) v1.0

 

Related Products

Certificate of Analysis

For information contact tech@speedx.com.au

 

Instructions for use

For information contact tech@speedx.com.au

 

Software Download

For information contact tech@speedx.com.au

Publications & Media

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.

The Journal of Antimicrobial Chemotherapy

Evaluation of the ResistancePlus GC (Beta) Assay: A Commercial Diagnostic Test for the Direct Detection of Ciprofloxacin Susceptibility or Resistance in Neisseria Gonorrhoeae

Ebeyan, S et al. Journal of Antimicrobial Chemotherapy 2019 Jul 1;74(7):1820-1824.

Evaluating the performance of the ResistancePlus® GC (beta) assay for the simultaneous detection of Neisseria gonorrhoeae and gyrA S91 markers of resistance (S91F) and susceptibility (WT) to ciprofloxacin, from both clinical specimens and isolates.

The Journal of Antimicrobial Chemotherapy

Improved Determination of Neisseria Gonorrhoeae Gyrase A Genotype Results in Clinical Specimens

Allan-Blitz L-T et al. Journal of Antimicrobial Chemotherapy 2019 Oct 1;74(10):2913-2915.

The ResistancePlus® GC (beta) assay showed improved N. gonorrhoeae gyrA genotype determination compared with a prior gyrA genotypic high-resolution melt assay.

Professor David Whiley SpeeDx IUSTI Asia Pacific Satellite Dinner 2018

Towards Individualised Treatment of Gonorrhoea 

Whiley D et al. SpeeDx Satellite Symposium (IUSTI Asia Pacific Sexual Health Congress) Nov 2, 2018, Auckland, New Zealand.

Discussion on the evolution of resistance in gonorrhoea, and to the design and application of diagnostic molecular tests for antibiotic resistance in gonorrhoea. Speaks to the mutations linked to ciprofloxacin susceptibility and resistance and introduces the broad-reaching clinical trials ongoing in Australia.

Ordering Information

Please contact SpeeDx for information about offering SpeeDx diagnostics in your clinic or for a list of current pathology clinics where SpeeDx testing is available.

Product Compatible Size Catalogue
ResistancePlus® GC* LC480 II 100 reactions 2011001
25 reactions 2011025
ABI 7500 / ABI 7500 Fast /
ABI 7500 Fast Dx҂
100 reactions 2013001
25 reactions 2013025
CFX96 IVD/CFX96 Touch# 100 reactions 2015001
25 reactions 2015025
ResistancePlus® GC Analysis Software* LC480 II 1 unit 99010
ABI 7500 / ABI 7500 Fast /
ABI 7500 Fast Dx
1 unit 99009
CFX96 IVD/CFX96 Touch 1 unit 99015
PlexPCR® Colour Compensation*^ kit LC480 II 2 reactions 90001
ResistancePlus® GC Control* kit All platforms 10 reactions 95003

*Not for sale in USA
Validated on LightCycler 480 II
҂Validated on ABI 7500 Fast and ABI 7500 Fast Dx
#Validated on CFX96 IVD and CFX96 Touch
^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.

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