Currently not for sale in the USA
ResistancePlus® MG FleXible
Sample-to-answer solution validated for all Cepheid GeneXpert® Systems.
Detect Mycoplasma genitalium and macrolide resistance markers.
Why use ResistancePlus® MG FleXible?
Mycoplasma genitalium (Mgen) infections contribute to a 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.
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 | ||
MG detection | Resistance markers | |
Sensitivity | 100% | 92.9% |
Specificity | 96.3% | 100% |
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), A2058T, A2058C, A2058G, A2059G and Internal control
Sample types
Urine: Male and female
Swabs: vaginal, cervical, rectal, and urethral
Amplification instruments
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 -25°C to -15°C. ResistancePlus® MG FleXible Cartridges (P/N:2000410-CART) are shipped and stored 2°C – 28°C.
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 – 25°C to – 15°C.
Intended use
For in vitro diagnostic use.
Regulatory status
CE-IVD (may not be available in all countries), TGA cleared, IVDR Certified
IFU and ADF files
Specifications
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.
Distributed exclusively by Cepheid
SpeeDx continues to partner 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
Product | Compatible | Size | Catalog |
ResistancePlus® MG FleXible | GeneXpert® (I, II, IV, XVI), and Infinity- (48s, 80) Instrument Systems | 10 reactions | S2A-2000410 |
SpeeDx has your control needs covered
Product | Compatible | Size | Catalog |
Cepheid GeneXpert® | 2 tests per positive control | S2A-95004 |
*Available in Australia and New Zealand. For EU/UK customers, please contact your Cepheid representative or email cepheid@cepheideurope.fr