A profile of the FDA-approved and CE/IVD-marked Aptima Mycoplasma genitalium assay (Hologic) and key priorities in the management of M. genitalium infections

References

• Horner PJ, Martin DH. Mycoplasma genitalium infection in men. J Infect Dis. 2017;216:S396.
   PubMed Web of Science ®Google Scholar
• Jensen JS, Cusini M, Gomberg M, et al. European guideline on Mycoplasma genitalium infections. J Eur Acad Dermatol Venereol. 2016;30:1650–1656.
   PubMed Web of Science ®Google Scholar
• Taylor-Robinson D, Jensen JS. Mycoplasma genitalium: from chrysalis to multicolored butterfly. Clin Microbiol Rev. 2011;24:498–514.
   PubMed Web of Science ®Google Scholar
• Wiesenfeld HC, Manhart LE. Mycoplasma genitalium in women: current knowledge and research priorities for this recently emerged pathogen. J Infect Dis. 2017;216:S389–S395.
   PubMed Web of Science ®Google Scholar
• Lis R, Rowhani-Rahbar A, Manhart LE. Mycoplasma genitalium infection and female reproductive tract disease: a meta-analysis. Clin Infect Dis. 2015;61:418–426.
   PubMed Web of Science ®Google Scholar
• Sonnenberg P, Ison CA, Clifton S, et al. Epidemiology of Mycoplasma genitalium in British men and women aged 16–44 years: evidence from the third National Survey of Sexual Attitudes and Lifestyles (Natsal-3). Int J Epidemiol. 2015;44:1982–1994.
   PubMed Web of Science ®Google Scholar
• Manhart LE, Gaydos CA, Taylor SN, et al. Characteristics of Mycoplasma genitalium urogenital infections in a diverse patient sample from the United States; results from the Aptima Mycoplasma genitalium Evaluation Study (AMES). J Clin Microbiol. 2020;58:e00165–20.
   PubMed Web of Science ®Google Scholar
• Soni S, Horner P, Rayment M, et al. British Association for Sexual Health and HIV national guideline for the management of infection with Mycoplasma genitalium (2018). Int J STD AIDS. 2019;30:938–950.
   PubMed Web of Science ®Google Scholar
• Edlund M, Blaxhult A, Bratt G. The spread of Mycoplasma genitalium among men who have sex with men. Int J STD AIDS. 2012;23:455–456.
   PubMed Web of Science ®Google Scholar
• Baumann L, Cina M, Egli-Gany D, et al. Prevalence of Mycoplasma genitalium in different population groups: systematic review and meta-analysis. Sex Transm Infect. 2018;94:255–261.
   PubMed Web of Science ®Google Scholar
• Unemo M, Jensen JS. Antimicrobial-resistant sexually transmitted infections: gonorrhoea and Mycoplasma genitalium. Nat Rev Urol. 2017;14:139–152.
   PubMed Web of Science ®Google Scholar
• Jensen JS, Bradshaw C. Management of Mycoplasma genitalium infections - can we hit a moving target? BMC Infect Dis. 2015;15:343.
   PubMed Web of Science ®Google Scholar
• Machalek DA, Tao Y, Shilling H, et al. Prevalence of mutations associated with resistance to macrolides and fluoroquinolones in Mycoplasma genitalium: a systematic review and meta-analysis. Lancet Infect Dis. 2020;S1473–3099:30154–30157.
   Google Scholar
• Jensen JS, Bradshaw CS, Tabrizi SN, et al. Azithromycin treatment failure in Mycoplasma genitalium – positive patients with nongonococcal urethritis is associated with induced macrolide resistance. Clin Infect Dis. 2008;47:1546–1553.
   PubMed Web of Science ®Google Scholar
• Deguchi T, Maeda S, Tamaki M, et al. Analysis of the gyrA and parC genes of Mycoplasma genitalium detected in first-pass urine of men with non-gonococcal urethritis before and after fluoroquinolone treatment. J Antimicrob Chemother. 2001;48:742–744.
   PubMed Web of Science ®Google Scholar
• Kikuchi M, Ito S, Yasuda M, et al. Remarkable increase in fluoroquinolone-resistant Mycoplasma genitalium in Japan. J Antimicrob Chemother. 2014;69:2376–2382.
   PubMed Web of Science ®Google Scholar
• Murray G, Bodiyabadu K, Danielewski J, et al. Moxifloxacin and sitafloxacin treatment failure in Mycoplasma genitalium infection: association with parC mutation G248T (S83I) and concurrent gyrA mutations. J Infect Dis. 2020;221:1017–1024.
   PubMed Web of Science ®Google Scholar
• Gaydos CA. Mycoplasma genitalium: accurate diagnosis is necessary for adequate treatment. J Infect Dis. 2017;216:S406–S411.
   PubMed Web of Science ®Google Scholar
• Jensen JS, Björnelius E, Dohn B, et al. Use of TaqMan 5′ nuclease real-time PCR for quantitative detection of Mycoplasma genitalium DNA in males with and without urethritis who were attendees at a sexually transmitted disease clinic. J Clin Microbiol. 2004;42:683–692.
   PubMed Web of Science ®Google Scholar
• Hilmarsdóttir I, Arnardóttir EM, Jóhannesdóttir ER, et al. Prevalence of Mycoplasma genitalium and antibiotic resistance-associated mutations in an Icelandic STI population, and comparison of the S-DiaMGTV and Aptima Mycoplasma genitalium assays for diagnosis. J Clin Microbiol. 2020.
   PubMed Web of Science ®Google Scholar
• Van Der Pol B. A profile of the cobas® TV/MG test for the detection of Trichomonas vaginalis and Mycoplasma genitalium. Expert Rev Mol Diagn. 2020;20:381–386.
   PubMed Web of Science ®Google Scholar
• Van Der Pol B, Waites KB, Xiao L, et al. Mycoplasma genitalium detection in urogenital specimens from symptomatic and asymptomatic men and women using the cobas TV/MG test. J Clin Microbiol. 2020;58:e02124–19.
   PubMed Web of Science ®Google Scholar
• Braam JF, van Marm S, Severs TT, et al. Sensitive and specific assay for the simultaneous detection of Mycoplasma genitalium and macrolide resistance-associated mutations. Eur J Clin Microbiol Infect Dis. 2018;37:2137–2144.
   PubMed Web of Science ®Google Scholar
• Drud ST, Njuguna P, Ebeyan S, et al. Evaluation of the ResistancePlus MG FleXible assay for detection of wild-type and 23S rRNA-mutated Mycoplasma genitalium strains. J Clin Microbiol. 2020;58:e01900–19.
   PubMed Web of Science ®Google Scholar
• Sweeney EL, Mhango LP, Ebeyan S, et al. Evaluation of the ResistancePlus MG FleXible cartridge for near-point-of-care testing of Mycoplasma genitalium and associated macrolide resistance mutations. J Clin Microbiol. 2020;58:e01897–19.
   PubMed Web of Science ®Google Scholar
• Murray GL, Danielewski J, Bradshaw CS, et al. Performance of the ResistancePlus MG diagnostic test for Mycoplasma genitalium using samples collected with hologic Aptima specimen collection kits. J Med Microbiol. 2020;69:244–248.
   PubMed Web of Science ®Google Scholar
• Su JP, Tan LY, Garland SM, et al. Evaluation of the SpeeDx ResistancePlus MG diagnostic test for Mycoplasma genitalium on the applied biosystems 7500 fast quantitative PCR platform. J Clin Microbiol. 2018;56:e01245–17.
   PubMed Web of Science ®Google Scholar
• Tabrizi SN, Su J, Bradshaw CS, et al. Prospective evaluation of ResistancePlus MG, a new multiplex quantitative PCR assay for detection of Mycoplasma genitalium and macrolide resistance. J Clin Microbiol. 2017;55:1915–1919.
   PubMed Web of Science ®Google Scholar
• Le Roy C, Le Hen I, Clerc M, et al. The first performance report for the Bio-Rad Dx CT/NG/MG assay for simultaneous detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium in urogenital samples. J Microbiol Methods. 2012;89:193–197.
   PubMed Web of Science ®Google Scholar
• Yoshida T, Deguchi T, Ito M, et al. Quantitative detection of Mycoplasma genitalium from first-pass urine of men with urethritis and asymptomatic men by real-time PCR. J Clin Microbiol. 2002;40:1451–1455.
   PubMed Web of Science ®Google Scholar
• Ursi D, Crucitti T, Smet H, et al. Evaluation of the Bio-Rad Dx CT/NG/MG® assay for simultaneous detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium in urine. Eur J Clin Microbiol Infect Dis. 2016;35:1159–1163.
   PubMed Web of Science ®Google Scholar
• De Salazar A, Espadafor B, Fuentes-López A, et al. Comparison between Aptima Assays (Hologic) and the Allplex STI Essential Assay (Seegene) for the diagnosis of sexually transmitted infections. PLoS ONE. 2019;14:1–9.
   Web of Science ®Google Scholar
• Le Roy C, Bébéar C, Pereyre S. Clinical evaluation of three commercial PCR assays for the detection of macrolide resistance in Mycoplasma genitalium. J Clin Microbiol. 2020;58:1–22.
   Web of Science ®Google Scholar
• Rumyantseva T, Golparian D, Nilsson CS, et al. Evaluation of the new AmpliSens multiplex real-time PCR assay for simultaneous detection of Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, and Trichomonas vaginalis. APMIS. 2015;123:879–886.
   PubMedGoogle Scholar
• Müller EE, Venter JME, Magooa MP, et al. Development of a rotor-gene real-time PCR assay for the detection and quantification of Mycoplasma genitalium. J Microbiol Methods. 2012;88:311–315.
   PubMed Web of Science ®Google Scholar
• Cao B, Wang S, Tian Z, et al. DNA microarray characterization of pathogens associated with sexually transmitted diseases. PLoS ONE. 2015;10:e0133927.
   PubMed Web of Science ®Google Scholar
• Kirkconnell B, Weinbaum B, Santos K, et al. Design and validation of transcription-mediated-amplification nucleic acid amplification tests for Mycoplasma genitalium. J Clin Microbiol. 2019;57:1–9.
   Web of Science ®Google Scholar
• Unemo M, Salado-Rasmussen K, Hansen M, et al. Clinical and analytical evaluation of the new Aptima Mycoplasma genitalium assay, with data on M. genitalium prevalence and antimicrobial resistance in M. genitalium in Denmark, Norway and Sweden in 2016. Clin Microbiol Infect. 2018;24:533–539.
   PubMed Web of Science ®Google Scholar
• Gaydos CA, Manhart LE, Taylor SN, et al. Molecular testing for Mycoplasma genitalium in the United States: results from the AMES prospective multicenter clinical study. J Clin Microbiol. 2019;57:1–12.
   Web of Science ®Google Scholar
• Tabrizi SN, Costa AM, Su J, et al. Evaluation of the Hologic Panther transcription-mediated amplification assay for detection of Mycoplasma genitalium. J Clin Microbiol. 2016;54:2201–2203.
   PubMed Web of Science ®Google Scholar
• Le Roy C, Pereyre S, Hénin N, et al. French prospective clinical evaluation of the Aptima Mycoplasma genitalium CE-IVD assay and macrolide resistance detection using three distinct assays. J Clin Microbiol. 2017;55:3194–3200.
   PubMed Web of Science ®Google Scholar
• Chernesky M, Jang D, Gilchrist J, et al. Head-to-head comparison of second-generation nucleic acid amplification tests for detection of Chlamydia trachomatis and Neisseria gonorrhoeae on urine samples from female subjects and self-collected vaginal swabs. J Clin Microbiol. 2014;52:2305–2310.
   PubMed Web of Science ®Google Scholar
• Mushanski LM, Brandt K, Coffin N, et al. Comparison of the BD Viper System with XTR Technology to the Gen-Probe APTIMA COMBO 2 Assay using the TIGRIS DTS system for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae in urine specimens. Sex Transm Dis. 2012;39:514–517.
   PubMed Web of Science ®Google Scholar
• Levett PN, Brandt K, Olenius K, et al. Evaluation of three automated nucleic acid amplification systems for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in first-void urine specimens. J Clin Microbiol. 2008;46:2109–2111.
   PubMed Web of Science ®Google Scholar
• Marlowe EM, Gohl P, Steidle M, et al. Trichomonas vaginalis detection in female specimens with cobas® TV/MG for use on the cobas® 6800/8800 systems. Eur J Microbiol Immunol. 2019;9:42–45.
   Web of Science ®Google Scholar
• Moncada J, Shayevich C, Philip SS, et al. Detection of Chlamydia trachomatis and Neisseria gonorrhoeae in rectal and oropharyngeal swabs and urine specimens from men who have sex with men with Abbott’s m2000 realtime. Sex Transm Dis. 2015;42:650–651.
   PubMed Web of Science ®Google Scholar
• Gaydos CA, Van Der Pol B, Jett-Goheen M, et al. Performance of the Cepheid CT/NG Xpert rapid PCR test for detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol. 2013;51:1666–1672.
   PubMed Web of Science ®Google Scholar
• Williams JA, Eddleman L, Pantone A, et al. Time-motion analysis of four automated systems for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae by nucleic acid amplification testing. J Lab Autom. 2014;19:423–426.
   PubMedGoogle Scholar
• Aretzweiler G, Leuchter S, Simon CO, et al. Generating timely molecular diagnostic test results: workflow comparison of the cobas® 6800/8800 to Panther. Expert Rev Mol Diagn. 2019;19:951–957.
   PubMed Web of Science ®Google Scholar
• Ratnam S, Jang D, Gilchrist J, et al. Workflow and maintenance characteristics of five automated laboratory instruments for the diagnosis of sexually transmitted infections. J Clin Microbiol. 2014;52:2299–2304.
   PubMed Web of Science ®Google Scholar
• Jang D, Ratnam S, Gilchrist J, et al. Comparison of workflow, maintenance, and consumables in the GeneXpert Infinity 80 and Panther Instruments while testing for Chlamydia trachomatis and Neisseria gonorrhoeae. Sex Transm Dis. 2016;43:377–381.
   PubMed Web of Science ®Google Scholar
• Hologic, Inc. Aptima Mycoplasma genitalium assay. Package insert [Internet]. [cited 2020 Jul 10]. Available from: https://www.hologic.com/sites/default/files/2019-04/AW-14170-001_007_01.pdf
   Google Scholar
• Hologic, Inc. Aptima unisex swab specimen collection kit for endocervical and male urethral swab specimens. Package insert [Internet]. [cited 2020 Jul 11]. Available from: https://www.hologic.com/sites/default/files/2018-07/502135EN-IFU-PI_005_01.pdf
   Google Scholar
• Hologic, Inc. Aptima specimen transfer kit. Package insert [Internet]. [cited 2020 Jul 11]. Available from: https://www.hologic.com/sites/default/files/2019-05/AW-11586-001_005_01.pdf
   Google Scholar
• Hologic, Inc. Aptima urine specimen collection kit for male and female urine specimens. Package insert [Internet]. [cited 2020 Jul 11]. Available from: https://www.hologic.com/sites/default/files/2018-10/502136EN-IFU-PI_005_01_1.pdf
   Google Scholar
• Hologic, Inc. Aptima multitest swab specimen collection kit for patient-collected specimens. Package insert [Internet]. [cited 2020 Jul 11]. Available from: https://www.hologic.com/sites/default/files/2020-07/AW-14334-001_006_01_0.pdf
   Google Scholar
• Chernesky M, Jang D, Smieja M, et al. Urinary meatal swabbing detects more men infected with Mycoplasma genitalium and four other sexually transmitted infections than first catch urine. Sex Transm Dis. 2017;44:489–491.
   PubMed Web of Science ®Google Scholar
• Dize L, Barnes P, Barnes M, et al. Performance of self-collected penile-meatal swabs compared to clinician-collected urethral swabs for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium by nucleic acid amplification assays. Diagn Microbiol Infect Dis. 2016;86:131–135.
   PubMed Web of Science ®Google Scholar
• Frølund M, Lidbrink P, Wikström A, et al. Urethritis-associated pathogens in urine from men with nongonococcal urethritis: A case-control study. Acta Derm Venereol. 2016;96:689–695.
   PubMed Web of Science ®Google Scholar
• Pitcher DG, Windsor D, Windsor H, et al. Mycoplasma amphoriforme sp. nov., isolated from a patient with chronic bronchopneumonia. Int J Syst Evol Microbiol. 2005;55:2589–2594.
   PubMed Web of Science ®Google Scholar
• Pereyre S, Renaudin H, Touati A, et al. Detection and susceptibility testing of Mycoplasma amphoriforme isolates from patients with respiratory tract infections. Clin Microbiol Infect. 2010;16:1007–1009.
   PubMed Web of Science ®Google Scholar
• Taylor-Robinson D, Gilroy CB, Keane FE. Detection of several Mycoplasma species at various anatomical sites of homosexual men. Eur J Clin Microbiol Infect Dis. 2003;22:291–293.
   PubMed Web of Science ®Google Scholar
• Wu JR, Wang B, Chen LS, et al. Alarming incidence of genital mycoplasmas among HIV-1-infected MSM in Jiangsu, China. Eur J Clin Microbiol Infect Dis. 2014;33:189–195.
   PubMed Web of Science ®Google Scholar
• Schachter J, Chernesky M. Alternate nucleic acid targets can be used to create a composite standard to evaluate clinical performance of nucleic acid amplification tests. J Clin Microbiol. 2019;57(8):e00661–19.
   PubMed Web of Science ®Google Scholar
• Hokynar K, Hiltunen-Back E, Mannonen L, et al. Prevalence of Mycoplasma genitalium and mutations associated with macrolide and fluoroquinolone resistance in Finland. Int J STD AIDS. 2018;29:904–907.
   PubMed Web of Science ®Google Scholar
• Gratrix J, Plitt S, Turnbull L, et al. Prevalence and antibiotic resistance of Mycoplasma genitalium among STI clinic attendees in Western Canada: A cross-sectional analysis. BMJ Open. 2017;7:e016300.
   PubMed Web of Science ®Google Scholar
• Chernesky MA, Jang D, Martin I, et al. Mycoplasma genitalium antibiotic resistance-mediating mutations in Canadian women with or without Chlamydia trachomatis infection. Sex Transm Dis. 2017;44:433–435.
   PubMed Web of Science ®Google Scholar
• Getman D, Jiang A, O’Donnell M, et al. Mycoplasma genitalium prevalence, coinfection, and macrolide antibiotic resistance frequency in a multicenter clinical study cohort in the United States. J Clin Microbiol. 2016;54:2278–2283.
   PubMed Web of Science ®Google Scholar
• Read TRH, Jensen JS, Fairley CK, et al. Use of pristinamycin for macrolide-resistant Mycoplasma genitalium infection. Emerg Infect Dis. 2018;24:328–335.
   PubMed Web of Science ®Google Scholar
• Ong JJ, Aung E, Read TRH, et al. Clinical characteristics of anorectal Mycoplasma genitalium infection and microbial cure in men who have sex with men. Sex Transm Dis. 2018;45:522–526.
   PubMed Web of Science ®Google Scholar
• Read TRH, Fairley CK, Murray GL, et al. Outcomes of resistance-guided sequential treatment of Mycoplasma genitalium infections: A prospective evaluation. Clin Infect Dis. 2019;68:554–560.
   PubMed Web of Science ®Google Scholar
• Durukan D, Read TRH, Murray G, et al. Resistance-guided antimicrobial therapy using doxycycline-moxifloxacin and doxycycline-2.5g azithromycin for the treatment of Mycoplasma genitalium infection: efficacy and tolerability. Clin Infect Dis. 2019;95:307–313.
   Web of Science ®Google Scholar
• Glaser AM, Geisler WM, Ratliff AE, et al. Two cases of multidrug-resistant genitourinary Mycoplasma genitalium infection successfully eradicated with minocycline. Int J STD AIDS. 2019;30:512–514.
   PubMed Web of Science ®Google Scholar
• Deguchi T, Ito S, Yasuda M, et al. Emergence of Mycoplasma genitalium with clinically significant fluoroquinolone resistance conferred by amino acid changes both in GyrA and ParC in Japan. J Infect Chemother. 2017;23:648–650.
   PubMed Web of Science ®Google Scholar
• Jensen JS, Fernandes P, Unemo M. In vitro activity of the new fluoroketolide solithromycin (CEM-101) against macrolide-resistant and -susceptible Mycoplasma genitalium strains. Antimicrob Agents Chemother. 2014;58:3151–3156.
   PubMed Web of Science ®Google Scholar
• Hook EW, Golden M, Jamieson BD, et al. A phase 2 trial of oral solithromycin 1200 mg or 1000 mg as single-dose oral therapy for uncomplicated gonorrhea. Clin Infect Dis. 2015;61:1043–1048.
   PubMed Web of Science ®Google Scholar
• Damião Gouveia AC, Unemo M, Jensen JS. In vitro activity of zoliflodacin (ETX0914) against macrolide-resistant, fluoroquinolone-resistant and antimicrobial-susceptible Mycoplasma genitalium strains. J Antimicrob Chemother. 2018;73:1291–1294.
   PubMed Web of Science ®Google Scholar
• Waites KB, Crabb DM, Duffy LB, et al. In vitro antibacterial activity of AZD0914 against human mycoplasmas and ureaplasmas. Antimicrob Agents Chemother. 2015;59:3627–3629.
   PubMed Web of Science ®Google Scholar
• Jensen JS, Nørgaard C, Scangarella-Oman N, et al. In vitro activity of the first-in-class triazaacenaphthylene gepotidacin alone and in combination with doxycycline against drug-resistant and -susceptible Mycoplasma genitalium. Emerg Microbes Infect. 2020;9:1388–1392.
   PubMed Web of Science ®Google Scholar
• Waites KB, Crabb DM, Xiao L, et al. In vitro activities of gepotidacin (GSK2140944) and other antimicrobial agents against human mycoplasmas and ureaplasmas. Antimicrob Agents Chemother. 2017;61(10):e01064-17. DOI:10.1128/AAC.01064-17.
   Web of Science ®Google Scholar
• Paukner S, Gruss A, Jensen JS. In vitro activity of lefamulin against sexually transmitted bacterial pathogens. Antimicrob Agents Chemother. 2018;62:e02380–17.
   PubMed Web of Science ®Google Scholar
• Unemo M, Seifert HS, Hook EW, et al. Gonorrhoea. Nat Rev Dis Primers. 2019;5:79.
   PubMed Web of Science ®Google Scholar