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Currently not for sale in the USA





ResistancePlus® MG


Enabling Resistance Guided Therapy

Detect Mycoplasma genitalium and macrolide resistance markers MgPa for M. genitalium detection, plus four 23S rRNA mutations (A2058T, A2058C, A2058G, A2059G) in a single-well multiplex qPCR test.




Why use ResistancePlus® MG?

Resistance to the macrolide treatment (Azithromycin) is of growing concern when managing M. genitalium (Mgen) infections. Guidelines around the world now call for the practice of Resistance Guided Therapy to guide appropriate treatment decisions, reduce potential for spreading infection among vulnerable populations, and support antibiotic stewardship.

  • Resistance Guided Therapy is clinically demonstrated to improve patient cure rate and overall patient management.

  • Detection of macrolide resistance can reduce time to cure, preventing ongoing transmission.

Tested on thousands of clinical samples, ResistancePlus® MG demonstrates excellent sensitivity and specificity.





ResistancePlus® MG workflow solution

Streamline your workflow and increase productivity for rapid, routine diagnostics. Full automation options include 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 sample collection devices

  • Validated on a range of sample extraction and qPCR platforms

 

SpeeDx analysis software is included in contract pricing, is license free, and installed on a high security and GDPR compliant platform. Designed to support the IVD laboratory environment, features include:

  • 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® MG Performance Specifications

Demonstrated clinical performance – for more detail please see the ResistancePlus® MG Instructions for Use.

Performance of ResistancePlus® MG


MG detection

Resistance markers

Sensitivity

98.8%

96.3%

Specificity

100%

91.3%


ResistancePlus® MG simultaneously detects Mycoplasma genitalium and 4 mutations at positions 2058 and 2059 in the 23S rRNA gene (E. coli numbering) that are associated with resistance to azithromycin (macrolide-based antibiotic).





Targets

Single well: M. genitalium (MgPa), A2058T, A2058C, A2058G, A2059G, Internal control

 

Sample types

Urine: Male and female

Swabs: vaginal

 

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. Not for sale in the USA.

 

Current software

ResistancePlus MG (LC480) v2.0

ResistancePlus MG (7500) v1.0

ResistancePlus MG (CFX) v1.0


Regulatory status

CE-IVD, UKCA, TGA cleared, Health Canada cleared, IVDR Certified, MoH Cleared




Learn more about ResistancePlus® MG



ResistancePlus® MG — a commercial product for over 10 years — has a well-documented history of provided clinical insights to assist with global antimicrobial resistance strategies – watch the video to learn more!


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® MG

LC480 II

100 reactions

20001L-01

ResistancePlus® MG

LC480 II

25 reactions

2000125

ResistancePlus® MG

ABI 7500 / ABI 7500 Fast / ABI 7500 Fast Dx

100 reactions

2000201

ResistancePlus® MG

ABI 7500 / ABI 7500 Fast / ABI 7500 Fast Dx

25 reactions

2000225

ResistancePlus® MG

CFX96 Dx / CFX96 Touch

100 reactions

2000301

ResistancePlus® MG

CFX96 Dx / CFX96 Touch

25 reactions

2000325

Accessory products

ResistancePlus® MG Analysis Software

LC480 II

1 unit

99003

ResistancePlus® MG Analysis Software

ABI 7500 / ABI 7500 Fast /ABI 7500 Fast Dx

1 unit

99002

ResistancePlus® MG Analysis Software

CFX96 Dx / CFX96 Touch

1 unit

99008

LC480 II

2 reactions

90001

All platforms

10 reactions

95001

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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