ResistancePlus® GC
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
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.
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, IVDR Certified
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 (z480) v1.0
- ResistancePlus® GC (7500) v1.0
- ResistancePlus® GC (CFX) v1.0
- REFLEX ResistancePlus® GC (LC480) v1.0
- REFLEX ResistancePlus® GC (z480) v1.0
- REFLEX ResistancePlus® GC (7500) v1.0
- REFLEX ResistancePlus® GC (CFX) v1.0
Certificate of Analysis
For information contact [email protected]
Instructions for use
For information contact [email protected]
Software Download
For information contact [email protected]
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.
Evaluation of the molecular detection of ciprofloxacin resistance in Neisseria gonorrhoeae by the ResistancePlus® assay (SpeeDx)
Cotton, S et al. Diagnostic Microbiology and Infectious Diseases 2020 Nov 12;99(4):115262.
Samples were selected from a range of sites with corresponding cultures isolated from the same patient episode. The ResistancePlus® GC assay displayed high sensitivity for N. gonorrhoeae detection (98.5%) and gyrA detection (97.1%). There was high agreement (98.9%) between the ResistancePlus® GC assay and culture phenotype.
Reflex detection of ciprofloxacin resistance in Neisseria gonorrhoeae using the SpeeDx ResistancePlus® GC Assay
Lee D.Y.J. et al. Journal of Clinical Microbiology 2020 Mar 3:JCM.00089. doi: 10.1128/JCM.00089-21.
Of the concordant N. gonorrhoeae – positive samples, (86.8%) possessed gyrA S91F mutation, highly predictive of ciprofloxacin resistance. Authors confirmed Resistance Guided Therapy (RGT) for gonorrhoea may reduce unnecessary use of broad spectrum antibiotics.
From the lab to the clinic: Finding your feet with molecular resistance testing
Winter A et al. SpeeDx Symposium (STI & HIV 2021 World Congress) July 16, 2021.
Drs Winter and Moss share practical learning from their experience of introducing molecular resistance testing for gonorrhoea into a large urban population. They discuss implementation considerations and describe how these systems helped influence treatment decisions. Including examples where molecular resistance testing made a difference in patient management.
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.
