Mycoplasma genitalium

ResistancePlus® MG

Detect Mycoplasma genitalium and macrolide resistance markers

MgPa for M. genitalium detection, plus five 23S rRNA mutations (A2058G, A2059G, A2059C, A2058T, A2058C) in a single-well multiplex qPCR test

 

Enabling Resistance Guided Therapy

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.

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

SpeeDx Resistance Plus MG product box
Scientist using thermocycler

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% 92.5%
Specificity 100% 100%

Specifications

ResistancePlus® MG simultaneously detects Mycoplasma genitalium and 5 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), A2058G, A2059G, A2059C, A2058T, A2058C, Internal control

 

Sample types

  • Urine: Male and female
  • Swabs: anal, rectal, cervical, endocervical, vaginal, and urethral
  • 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, Health Canada cleared

Resources

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

Safety Data Sheets

 

Current Software Version

  • ResistancePlus® MG (LC480) v3.0
  • ResistancePlus® MG (7500) v2.0
  • ResistancePlus® MG (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.

Resistance Guided therapy. Journal. Infectious Diseases Society of America

Resistance-guided Antimicrobial Therapy Using Doxycycline-Moxifloxacin and doxycycline-2.5g Azithromycin for the Treatment of Mycoplasma Genitalium Infection: Efficacy and Tolerability

Durukan D et al. Clinical Infectious Diseases 2019 Oct 20;ciz1031. doi: 10.1093/cid/ciz1031.

Used ResistancePlus® MG to support Resistance Guided Therapy for Mgen infections, curing 92% and 95% of macrolide-resistant and macrolide-susceptible infections. Providing an evidence-base for current UK, Australian and European guidelines for the treatment of Mgen.

M. genitalium

Prevalence of Mycoplasma Genitalium Infection in Women With Bacterial Vaginosis

Nye M et al. BMC Womens Health 2020 Mar 26;20(1):62.

Used ResistancePlus® MG to investigate over 1500 symptomatic vaginitis patients. Mgen infection was more prevalent in women with bacterial vaginosis (BV) (7.0% Mgen positive) compared with non-BV vaginitis (3.6% Mgen positive). Macrolide resistance mediating mutations observed in over 37% of Mgen positive samples.

Mycoplasma genitalium – Management in the Era of Escalating Antimicrobial Resistance

Mycoplasma genitalium – Management in the Era of Escalating Antimicrobial Resistance

Bradshaw C et al. SpeeDx Satellite Symposium (STI & HIV World Congress) July 12, 2017.

Results shared from the flagship Resistance Guided Therapy study demonstrating significant increases in cure rate of Mgen infections from  less than 60% to over 92% using ResistancePlus® MG to identify macrolide sensitive and resistance infections to inform patient treatment.

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® MG* LC480 II 100 reactions 20001L-01
25 reactions 2000125
ABI 7500 / ABI 7500 Fast /
ABI 7500 Fast Dx҂
100 reactions 2000201
25 reactions 2000225
CFX96 IVD/CFX96 Touch# 100 reactions 2000301
25 reactions 2000325
ResistancePlus® MG Analysis Software* LC480 II 1 unit 99002
ABI 7500 / ABI 7500 Fast /
ABI 7500 Fast Dx
1 unit 99003
CFX96 IVD/CFX96 Touch 1 unit 99008
PlexPCR® Colour Compensation*^ kit LC480 II 2 reactions 90001
ResistancePlus® MG Positive Control* kit All platforms 10 reactions 95001

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