Evaluation of Mycoplasma genitalium positivity and co-infection with Chlamydia trachomatis and/or Neisseria gonorrhoeae at various care sites across the United States

Objectives We evaluated Mycoplasma genitalium (MG) positivity and co-infection with Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG), based on results from a trial assessing clinical performance of the Cobas® Liat CT/NG/MG point-of-care test. Methods A prospective, US, multicenter, noninterventional study assessed MG positivity in prospective urine samples (male) and clinician-collected vaginal swabs (female) from symptomatic/asymptomatic patients aged ≥14 years attending various clinical settings. Participants were designated positive or negative for MG, CT, and NG based on combined results from three US Food and Drug Administration-approved assays and one laboratory-developed test. MG co-infection with CT and/or NG was assessed. Results Among 4818 evaluable participants, median age was 35.0 years (range: 15.0-81.0), 40.3% were symptomatic, and 51.6% were assigned female sex at birth. MG positivity was 9.6% overall (symptomatic participants: 11.6%; asymptomatic participants: 8.2%). Among 4811 participants with valid results for all analytes, 0.1% were positive for MG, CT, and NG, 1.0% were co-infected with MG/CT; and 0.3% were co-infected with MG/NG. Conclusions MG positivity was high and MG co-infection with CT was common. These findings improve understanding of MG prevalence and may help inform the targeting of MG screening to specific patient populations. Co-infection data support using multiplex testing to facilitate targeted treatment decisions.