Multiplex Assay for Simultaneous Detection of Mycoplasma genitalium and Macrolide Resistance Using PlexZyme and PlexPrime Technology.
Mycoplasma genitalium is a cause of non-gonoccocal urethritis (NGU) in men and cervicitis and pelvic inflammatory disease in women. Recent international data also indicated that the first line treatment, 1 gram stat azithromycin therapy, for M. genitalium is becoming less effective, with the corresponding emergence of macrolide resistant strains. Increasing failure rates of azithromycin for M. genitalium has significant implications for the presumptive treatment of NGU and international clinical treatment guidelines. Assays able to predict macrolide resistance along with detection of M. genitalium will be useful to enable appropriate selection of antimicrobials to which the organism is susceptible and facilitate high levels of rapid cure. One such assay recently developed is the MG 23S assay, which employs novel PlexZyme™ and PlexPrime™ technology. It is a multiplex assay for detection of M. genitalium and 5 mutations associated with macrolide resistance. The assay was evaluated in 400 samples from 254 (186 males and 68 females) consecutively infected participants, undergoing tests of cure. Using the MG 23S assay, 83% (331/440) of samples were positive, with 56% of positives carrying a macrolide resistance mutation. Comparison of the MG 23S assay to a reference qPCR method for M. genitalium detection and high resolution melt analysis (HRMA) and sequencing for detection of macrolide resistance mutations, resulted in a sensitivity and specificity for M. genitalium detection and for macrolide resistance of 99.1/98.5% and 97.4/100%, respectively. The MG 23S assay provides a considerable advantage in clinical settings through combined diagnosis and detection of macrolide resistance.
Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, Victoria, Australia.|Department of Obstetrics and Gynecology, University of Melbourne, Victoria, Australia.|Murdoch Childrens Research Institute, Parkville, Victoria, Australia.
Sepehr N
SN
Tabrizi
SpeeDx Pty Ltd, Sydney, NSW, Australia.
Lit Y
LY
Tan
SpeeDx Pty Ltd, Sydney, NSW, Australia.
Samantha
S
Walker
Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, Victoria, Australia.|Department of Obstetrics and Gynecology, University of Melbourne, Victoria, Australia.
Jimmy
J
Twin
Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, Victoria, Australia.|Department of Obstetrics and Gynecology, University of Melbourne, Victoria, Australia.
Marin
M
Poljak
Melbourne Sexual Health Centre, Carlton, Victoria, Australia.|Central Clinical School, Monash University, Victoria, Australia.
Catriona S
CS
Bradshaw
Melbourne Sexual Health Centre, Carlton, Victoria, Australia.|Central Clinical School, Monash University, Victoria, Australia.
Christopher K
CK
Fairley
Melbourne Sexual Health Centre, Carlton, Victoria, Australia.
Melanie
M
Bissessor
SpeeDx Pty Ltd, Sydney, NSW, Australia.
Elisa
E
Mokany
SpeeDx Pty Ltd, Sydney, NSW, Australia.
Alison V
AV
Todd
Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, Victoria, Australia.|Department of Obstetrics and Gynecology, University of Melbourne, Victoria, Australia.|Murdoch Childrens Research Institute, Parkville, Victoria, Australia.
Suzanne M
SM
Garland
D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D015373:Bacterial Typing Techniques / Q000379:methods; D004252:DNA Mutational Analysis / Q000379:methods; D024881:Drug Resistance, Bacterial / Q000235:genetics*; D005260:Female; D006801:Humans; D018942:Macrolides / Q000627:therapeutic use*; D008297:Male; D008826:Microbial Sensitivity Tests / Q000379:methods; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods*; D009175:Mycoplasma Infections / Q000175:diagnosis* / Q000188:drug therapy / Q000382:microbiology; D045704:Mycoplasma genitalium / Q000187:drug effects / Q000235:genetics / Q000302:isolation & purification; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D014526:Urethritis / Q000175:diagnosis / Q000188:drug therapy / Q000382:microbiology
D000900:Anti-Bacterial Agents; D018942:Macrolides