Fast and Accurate Diagnosis of Chlamydia and Gonorrhea
M. genitalium is a recognised Sexually Transmitted Infection (STI), treated syndromically, with clinical presentation similar to that of Chlamydia trachomatis.1
Prevalence of M. genitalium infections in the general population ranges from 1-4%2, and its treatment is challenging due to high levels of macrolide resistance.5
- Macrolide resistance testing is recommended by international and local guidelines on management of M. genitalium infections.3,4,6-8
- Macrolide resistance testing can guide appropriate treatment choice enabling Resistance Guided Therapy.6
- Resistance Guided Therapy is clinically demonstrated to improve patient cure rate and overall patient management.9
- Fast detection of macrolide resistance can reduce time to cure, preventing ongoing transmission.9
- ResistancePlus® MG FleXible detects both M. genitalium and macrolide resistance in ~ 2 hours.
- ResistancePlus® MG FleXible offers a fast and simple solution in combination with GeneXpert®Systems. Easily implemented into your existing workflow or setting, with minimal preparation time ~ 10 mins.
- High performance test validates a wide range of specimen types and collection devices, including urine and swabs (vaginal, cervical, rectal).**
Improving patient management
ResistancePlus® MG FleXible provides therapeutic guidance recommendations, enabling clinicians to make informed treatment decisions. Resistance guided therapy is clinically demonstrated to increase overall patient cure rate.9
ResistancePlus® MG FleXible is validated on a wide range of sample types including rectal, male and female urine, and common collection swab kits including Xpert® CT/NGVaginal/Endocervical Specimen Collection kit and Xpert® CT/NG Urine Specimen Collection Kit.**
CE-IVD in Vitro Diagnostic Medical Device. Not available in all countries.
*Exclusively distributed by Cepheid under the FleXible by GeneXpert® System program
**Validated specimens: male and female urine, vaginal swab, cervical swab, rectal swab, urethral swab, from symptomatic and asymptomatic patients. Validated collection kits: Xpert® Vaginal/Endocervical and Xpert® Urine Specimen Collection Kits, Neat urine, Regular FLOQSwab™ in 3 ml of UTM™ media, cobas PCR collection media. For details refer to the ResistancePlus® MG FleXible Instructions For Use (IF-IV0012)
1. Manhart LE and Kay N.Mycoplasma genitalium: Is It a Sexually Transmitted Pathogen? Curr. Infect. Dis. Reps. 2010; 12(4):306-313.
2. Cools et al, Lancet Infectious DiseasesVol. 20No. 11p1222–1223
3. 2018 BASHH UK national guideline for the management of infection withMycoplasma genitalium. Available online at https://www.bashhguidelines.org/media/1198/mg-2018.pdf
4. Jensen et al. 2016 European guideline onMycoplasma genitalium infections. J Eur Acad Dermatol Venereol. 2016 Oct;30(10):1650-1656.
5. Unemo, M et al. Antimicrobial-resistant sexually transmitted infections: gonorrhoea andMycoplasma genitalium. Nat Rev Urol. 2017 Mar;14(3):139-152.
6. Horner PJ et al. 2016 European guideline on the management of non-gonococcal urethritis. Int J STD AIDS. 2016 Oct;27(11):928-37.
7. Australian STI Management Guidelines – Mycoplasma genitalium 2018. http://www.sti.guidelines.org.au/sexually-transmissible-infections/mycoplasma-genitalium
8. Groupe Infectiologie Dermatologique et Infections Sexuellement GRIDIST and Société Fançaise de Dermatologie – Press Release. Available online at: https://www.sfdermato.org/actualites/communique-commun-gridist-et-sfd.html
9. Read TRH et al. Outcomes of Resistance-guided Sequential Treatment of Mycoplasma genitalium Infections: A Prospective Evaluation. Clin Infect Dis. 2019 Feb 1;68(4):554-560.
ResistancePlus® MG FleXible tests are developed and manufactured by SpeeDx Pty Ltd, Sydney. PlexPCR® & ResistancePlus® are trademarks of SpeeDx Pty Ltd. Other copyright and trademarks are the property of the respective owners. SpeeDx Pty Ltd products may be covered by one or more local or foreign patents. Visit www.plexpcr.com/patents for comprehensive patent information
ResistancePlus® MG FleXible
10 testsCatalog #: S2A-2000410
ResistancePlus®MG S2A Positive Control
10 testsCatalog #: S2A-95004
Xpert Vaginal/Endocervical Specimen Collection kits – 50 ready-to-use individual kitsCatalog #: SWAB/A-50, SWAB/G-50
50 Ready-To-Use Individual KitsCatalog #: URINE/A-50
Evaluation of ResistancePlus® MG FleXible
Evaluation of ResistancePlus MG FleXible, a 'near-patient' test for the detection of Mycoplasma genitalium and macrolide resistance mutations, using freshly collected clinical samples