TABLE 2.

Examples of commercial molecular tests for detection of M. genitalium that have been CE marked and/or FDA cleared^a

Product	Manufacturer(s); platform(s)	Method(s) of detection	Pathogen(s) detected	M. genitalium target(s)	Detection of macrolide resistance mutationsb	Regulatory status	Selected reference(s)
Aptima Mycoplasma genitalium	Hologic, Marlborough, MA; Panther	TMA, HPA, PCR	M. genitalium	16S rRNA	No	FDA, CE	107–110, 113, 174, 200–207
cobas TV/MG detection	Roche Molecular Systems, Pleasanton, CA; cobas 6800/8800	PCR	M. genitalium, T. vaginalis	16S rRNA	No	FDA, CE	112 – 114
Alinity m STI	Abbott Molecular Diagnostics, Des Plaines, IL; Alinity m	PCR	N. gonorrhoeae, C. trachomatis, T. vaginalis, M. genitalium	rRNA	No	FDA, CE	208
STI Plus ELITe MGB	ELITechGroup, Bothell, WA; ELITe InGenius	PCR	N. gonorrhoeae, C. trachomatis, T. vaginalis, M. genitalium	23S rRNA	No	CE	114
Allplex STI Essential	Seegene, Seoul, South Korea; Bio-Rad Cfx96	PCR	N. gonorrhoeae, C. trachomatis, M. genitalium, T. vaginalis, M. hominis, U. urealyticum, U. parvum	mgpA	No	CE	108, 109, 114, 178, 207
Bio-Rad Dx CT/NG/MG	Bio-Rad, Marnes-la-Coquette, France; Bio-Rad Dx real-time system	PCR	N. gonorrhoeae, C. trachomatis, M. genitalium	mgpA	No	CE	2, 116, 117
Hyplex STD mycoplasma test system	Amplex Biosystems, Lich, Germany	PCR	M. genitalium, M. hominis, U. urealyticum, U. parvum	mgpA	No	CE	2, 118
N. gonorrhoeae/C. trachomatis/M. genitalium/T. vaginalis Real-TM	Sacace Biotechnologies, Como, Italy	PCR	N. gonorrhoeae, C. trachomatis, T. vaginalis, M. genitalium	Undisclosed	No	CE	114
FTD Urethritis Plus	Fast-Track Diagnostics, Luxembourg	PCR	N. gonorrhoeae, C. trachomatis, T. vaginalis, M. genitalium, U. urealyticum, U. parvum, M. hominis	Undisclosed	No	CE	2, 114
AmpliSens N. gonorrhoeae/C. trachomatis/M. genitalium/T. vaginalis-Multiprime FRT assay	InterLabService, Moscow, Russia	PCR	N. gonorrhoeae, C. trachomatis, T. vaginalis, M. genitalium	gyrB	No	CE	2, 111
S-DiaMGTV	Diagenode, Liege, Belgium	PCR	M. genitalium, T. vaginalis	mgpA, MG219	No	CE	2, 115, 209, 210
ResistancePlus MG FleXible	SpeeDx/Cepheid, Sydney, Australia, Cepheid GeneXpert, Sunnyvale, CA	PlexZyme, PlexPrime technology, PCR	M. genitalium	mgpA	Yes, 4 mutations, A2058G/C/T and A2059C	CE	167, 177–180
ResistancePlus MG	SpeeDx, Sydney, Australia	PlexZyme, PlexPrime technology, PCR	M. genitalium	mgpA	Yes, 5 mutations, A2058G/C/T and A2059C/G	CE	109, 110, 123, 133, 136, 154, 170–175, 203
Macrolide-R/MG ELITe MGB	ELITechGroup, Bothell, WA; ELITe InGenius	PCR	M. genitalium	23S rRNA	Yes, 5 mutations, A2058G/C/T and A2059G/C, and WT	CE	160, 180
Allplex MG & AziR	Seegene, Seoul, South Korea; Bio-Rad Cfx 96	PCR	M. genitalium	mgpA	Yes, 6 mutations, A2058G/C/T and A2059G/C/T	CE	109, 180
S-DiaMGRes	Diagenode, Liege, Belgium	PCR	M. genitalium	MG219	Yes, 5 mutations, A2058G/C/T and A2059G/C	CE	173, 176, 208
Real-Accurate TVMGres	Pathofinder, Maastricht, Netherlands	PCR	M. genitalium, T. vaginalis	mgpA	Yes, 4 mutations, A2058G/C/T and A2059G	CE	173

^aAdapted from Table 4 in reference 211. TMA, transcription-mediated amplification; HPA, hybridization protection assay; CE-IVD, approved Communauté Européenne marking on in vitro diagnostic medical devices; FDA, U.S. Food and Drug Administration; WT, wild type.

^b23S rRNA mutations that are known to confer macrolide resistance in M. genitalium (E. coli numbering).