Mgen

ResistancePlus® MG FleXible

Detect Mycoplasma genitalium and macrolide resistance markers

Sample-to-answer solution validated for all Cepheid GeneXpert® Systems

Why use ResistancePlus® MG FleXible?

Mycoplasma genitalium (Mgen) infections contribute to significant portion of non-chlamydial non-gonococcal urethritis in men and in women and treatment is challenging due to high levels of macrolide resistance.

ResistancePlus® MG FleXible offers simultaneous detection and identification of M. genitalium and azithromycin (macrolide) resistance to support appropriate treatment decisions at the earliest opportunity for improved patient management.

Validated on hundreds of clinical samples, ResistancePlus® MG FleXible demonstrates excellent sensitivity and specificity.

MG FleXible product

ResistancePlus® MG FleXible workflow solution

ResistancePlus® MG FleXible brings accuracy and simplicity to your lab in combination with GeneXpert® Systems for a complete solution. Easily implemented into your existing workflow or setting.

  • Minimal preparation time ~ 10 mins
  • Actionable results in around 2 hours
  • Validated on a range of specimen types and collection devices

ResistancePlus® MG FleXible Performance Specifications

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

Performance of ResistancePlus® MG FleXible
MG detection Resistance markers
Sensitivity 100% 92.9%
Specificity 96.3% 100%

Specifications

The ResistancePlus® MG FleXible assay is a qualitative multiplexed in vitro diagnostic real-time PCR test for the identification of M. genitalium and detection of mutations in the 23S rRNA gene, that are associated with resistance to azithromycin (macrolide antibiotic).

Targets

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

 

Sample types

  • Urine: Male and female
  • Swabs: vaginal, cervical, rectal, and urethral

 

Amplification instrument

  • GeneXpert® Instrument Systems (Cepheid)

Shipping Conditions

The components of the ResistancePlus® MG FleXible kit (P/N:2000410-R) are shipped on dry ice or ice gel packs and stored at -20°C. ResistancePlus® MG FleXible Cartridges (P/N:2000410-CART) are shipped and stored 2°C – 28°C.

Each shipment will include a ResistancePlus® MG FleXible CD (P/N:CD-MG-FLEX), containing Instructions for Use (IFU) and the Assay Definitiion File (ADF) needed to run the ResistancePlus® MG FleXible kit on the GeneXpert® Instrument.

 

Storage & stability

Expiry dates are stated on the labels. It is recommended that freeze/thaw cycles be limited to less than 8. Store protected from light at – 20°C.

 

Intended use

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

 

Regulatory status

CE-IVD (may not be available in all countries), TGA cleared

Resources

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

Information Brochures

 

Package Inserts

 

Clinical Performance Studies

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.

Diagnostic Microbiolody and infectious Diseases

Clinical evaluation of the ResistancePlus MG FleXible test on the GeneXpert Infinity-48 s instrument: A near-patient assay for simultaneous detection of Mycoplasma genitalium and macrolide resistance

Fernández-Huerta M et al. Diagnostic Microbiology and infectious Disease In Press Available online 17 April 2020

ResistancePlus® MG FleXible performance compared with Seegene Allplex STI essential assay and against Sanger sequencing. Tested146 samples (95 Mgen positive, 51 Mgen Negative) resulting in 94.7% positive agreement, and 100% negative agreement for Mgen detection and 94.1% positive agreement and 96.0% negative agreement.

Journal of Clinical Microbiology

Evaluation of the ResistancePlus MG FleXible Cartridge for Near-Point-of-Care Testing of Mycoplasma Genitalium and Associated Macrolide Resistance Mutations

Sweeney EL et al. Journal of Clinical Microbiology 2020 Feb 24;58(3):e01897-19.

Tested 181 clinical samples tested with ResistancePlus® MG FleXible and compared with in-house Mgen assay and open platform ResistancePlus® MG. Results demonstrated the cartridge test was highly sensitive and specific for the detection of M. genitalium and 23S rRNA mutations.

Journal of Clinical Microbiology

Evaluation of the ResistancePlus MG FleXible Assay for Detection of Wild-Type and 23S rRNA-Mutated Mycoplasma Genitalium Strains

Drud ST et al. Journal of Clinical Microbiology 2020 Feb 24;58(3):e01900-19.

ResistancePlus® MG FleXible was evaluated for analytical sensitivity, specificity, reproducibility, inhibition, plus clinical sensitivity compared with a reference real-time PCR assay. Found to be more sensitive than the reference MgPa assay, and concluded it may increase ease of use and considerably decrease hands-on time for sample preparation.

Distributed exclusively by Cepheid

SpeeDx Pty. Ltd. announced an agreement with Cepheid to manufacture their market-leading ResistancePlus® MG tests for use on the GeneXpert® System. ResistancePlus® MG FleXible is the first test in Cepheid’s FleXible Cartridge program.

 

For more information, contact your Cepheid representative or email cepheid@cepheideurope.fr

Want ResistancePlus® MG in your laboratory?