Abstract
Data from a large prospective multicenter clinical validation study of a nucleic acid amplification in vitro diagnostic test for Mycoplasma genitalium were analyzed to describe the prevalence of M. genitalium infection, risk factors, and disease associations in female and male patients seeking care in diverse geographic regions of the United States. Among 1,737 female and 1,563 male participants, the overall prevalence of M. genitalium infection was 10.3% and was significantly higher in persons ages 15 to 24 years than in persons ages 35 to 39 years (for females, 19.8% versus 4.7% [odds ratio {OR} = 5.05; 95% confidence interval {CI} = 3.01 to 8.46]; for males, 16.5% versus 9.4% [OR = 1.91; 95% CI = 1.20 to 3.02]). The risk for M. genitalium infection was higher in black than in white participants (for females, 12.0% versus 6.8% [OR = 1.88; 95% CI = 1.30 to 2.72]; for males, 12.9% versus 6.9% [OR = 2.02; 95% CI = 1.38 to 2.96]) and higher in non-Hispanic than in Hispanic participants (for females, 11.2% versus 6.0% [OR = 1.97; 95% CI = 1.25 to 3.10]; for males, 11.6% versus 6.8% [OR = 1.80; 95% CI = 1.14 to 2.85]). Participants reporting urogenital symptoms had a significantly elevated risk of M. genitalium infection compared to that for asymptomatic individuals (for females, OR = 1.53 [95% CI = 1.09 to 2.14]; for males, OR = 1.42 [95% CI = 1.02 to 1.99]). Women diagnosed with vaginitis and cervicitis had a higher prevalence of M. genitalium infection than women without those diagnoses, although this was statistically significant only for vaginitis (for vaginitis, OR = 1.88 [95% CI = 1.37 to 2.58]; for cervicitis, OR = 1.42 [95% CI = 0.61 to 2.96]). A diagnosis of urethritis in men was also significantly associated with M. genitalium infection (OR = 2.97; 95% CI = 2.14 to 4.13). Few characteristics distinguished asymptomatic from symptomatic M. genitalium infections. These results from persons seeking care in the United States suggest that M. genitalium infection should be considered in young persons presenting with urogenital symptoms.
Highlights
Data from a large prospective multicenter clinical validation study of a nucleic acid amplification in vitro diagnostic test for Mycoplasma genitalium were analyzed to describe the prevalence of M. genitalium infection, risk factors, and disease associations in female and male patients seeking care in diverse geographic regions of the United States
Infection with Mycoplasma genitalium has been linked with female cervicitis, pelvic inflammatory disease (PID), and preterm delivery [5, 6], as well as with male urethritis [7], but the causal relationship between infection and adverse sequelae in women is not well understood, and screening is not currently recommended, as some of these associations may be inconsistent [6]
We estimated the prevalence of M. genitalium infection and disease associations in a large, diverse population of patients from broad geographic settings across the United States
Summary
Data from a large prospective multicenter clinical validation study of a nucleic acid amplification in vitro diagnostic test for Mycoplasma genitalium were analyzed to describe the prevalence of M. genitalium infection, risk factors, and disease associations in female and male patients seeking care in diverse geographic regions of the United States. While a number of nucleic acid amplification tests (NAAT), including research-use-only assays and Conformité Européenne (CE)-marked assays, have been in use since the early 1990s, the U.S Food and Drug Administration (FDA) cleared the first M. genitalium NAAT, the Aptima Mycoplasma genitalium (AMG) assay (Hologic, Inc., San Diego, CA), in early 2019, paving the way for the more widespread consideration of this organism in clinical care in the United States This is important, because recommended empirical therapy for these syndromes [6] is suboptimal for M. genitalium, and more widely available diagnostic tests will permit clinicians to better target appropriate treatment to the infecting pathogen. We estimated the prevalence of M. genitalium infections and evaluated the association of M. genitalium infection with reproductive tract symptoms, signs, and diagnoses in persons seeking care at geographically diverse locations in the United States
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