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      Mycoplasma genitalium Detection in Urogenital Specimens from Symptomatic and Asymptomatic Men and Women by Use of the cobas TV/MG Test

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          Abstract

          Mycoplasma genitalium (MG) infections are a growing concern within the field of sexually transmitted infections. However, diagnostic assays for M. genitalium have been limited in the United States. As most infections are asymptomatic, individuals can unknowingly pass the infection on, and the prevalence is likely to be underestimated. Diagnosis of M. genitalium infection is recommended using a nucleic acid test. This multicenter study assessed the performance of the cobas Trichomonas vaginalis (TV)/MG assay (cobas) for the detection of M. genitalium, using 22,150 urogenital specimens from both symptomatic and asymptomatic men and women collected at geographically diverse sites across the United States.

          ABSTRACT

          Mycoplasma genitalium (MG) infections are a growing concern within the field of sexually transmitted infections. However, diagnostic assays for M. genitalium have been limited in the United States. As most infections are asymptomatic, individuals can unknowingly pass the infection on, and the prevalence is likely to be underestimated. Diagnosis of M. genitalium infection is recommended using a nucleic acid test. This multicenter study assessed the performance of the cobas Trichomonas vaginalis (TV)/MG assay (cobas) for the detection of M. genitalium, using 22,150 urogenital specimens from both symptomatic and asymptomatic men and women collected at geographically diverse sites across the United States. The performance was compared to a reference standard of three laboratory-developed tests (LDTs). The specificity of the cobas assay for M. genitalium ranged from 96.0% to 99.8% across symptomatic and asymptomatic men and women. The sensitivities in female vaginal swabs and urine samples were 96.6% (95% confidence interval [CI], 88.5 to 99.1%) and 86.4% (95% CI, 75.5 to 93.0%), respectively. The sensitivities in male urine and meatal swab samples were 100% (95% CI, 94.0 to 100%) and 85.0% (95% CI, 73.9 to 91.9%), respectively. This study demonstrated that the cobas assay was highly sensitive and specific in all relevant clinical samples for the detection of M. genitalium.

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          Most cited references36

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          Prevalence of Mycoplasma genitalium in different population groups: systematic review andmeta-analysis

          Background Mycoplasma genitalium is a common cause of non-gonococcal non-chlamydial urethritis and cervicitis. Testing of asymptomatic populations has been proposed, but prevalence in asymptomatic populations is not well established. We aimed to estimate the prevalence of M. genitalium in the general population, pregnant women, men who have sex with men (MSM), commercial sex workers (CSWs) and clinic-based samples. Methods We searched Embase, Medline, IndMED, African Index Medicus and LILACS from 1 January 1991 to 12 July 2016 without language restrictions. We included studies with 500 participants or more. Two reviewers independently screened and selected studies and extracted data. We examined forest plots and conducted random-effects meta-analysis to estimate prevalence, if appropriate. Between-study heterogeneity was examined using the I2 statistic and meta-regression. Results Of 3316 screened records, 63 were included. In randomly selected samples from the general population, the summary prevalence was 1.3% (95% CI 1.0% to 1.8%, I2 41.5%, three studies, 9091 people) in countries with higher levels of development and 3.9% (95% CI 2.2 to 6.7, I2 89.2%, three studies, 3809 people) in countries with lower levels. Prevalence was similar in women and men (P=0.47). In clinic based samples, prevalence estimates were higher, except in asymptomatic patients (0.8%, 95% CI 0.4 to 1.4, I2 0.0%, three studies, 2889 people). Summary prevalence estimates were, in the following groups: pregnant women 0.9% (95% CI 0.6% to 1.4%, I2 0%, four studies, 3472 people), MSM in the community 3.2% (95% CI 2.1 to 5.1, I2 78.3%, five studies, 3012 people) and female CSWs in the community 15.9% (95% CI 13.5 to 18.9, I2 79.9%, four studies, 4006 people). Discussion This systematic review can inform testing guidelines for M. genitalium. The low estimated prevalence of M. genitalium in the general population, pregnant women and asymptomatic attenders at clinics does not support expansion of testing to these groups. Registration numbers PROSPERO: CRD42015020420
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            Mycoplasma genitalium among young adults in the United States: an emerging sexually transmitted infection.

            We sought to determine the prevalence of and risk factors associated with Mycoplasma genitalium infection in a nationally representative sample of young adults in the United States. Urine specimens from 1714 women and 1218 men who participated in Wave III of the National Longitudinal Study of Adolescent Health (N=14322) were tested for M genitalium. Poststratification sampling weights were used to generate nationally representative estimates. The prevalence of M genitalium was 1.0% compared with 0.4%, 4.2%, and 2.3% for gonococcal, chlamydial, and trichomonal infections, respectively. No M genitalium-positive individuals reported symptoms of discharge. M genitalium prevalence among those who reported vaginal intercourse was 1.1% compared with 0.05% among those who did not. In multivariate analyses, M genitalium prevalence was 11 times higher among respondents who reported living with a sexual partner, 7 times higher among Blacks, and 4 times higher among those who used condoms during their last vaginal intercourse. Prevalence of M genitalium increased by 10% for each additional sexual partner. M genitalium was more prevalent than Neisseria gonorrhoeae but less prevalent than Chlamydia trachomatis, and it was strongly associated with sexual activity.
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              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)

              Background: There are currently no large general population epidemiological studies of Mycoplasma genitalium (MG), which include prevalence, risk factors, symptoms and co-infection in men and women across a broad age range. Methods: In 2010-–12, we conducted the third National Survey of Sexual Attitudes and Lifestyles (Natsal-3), a probability sample survey in Britain. Urine from 4507 sexually-experienced participants, aged 16–44 years, was tested for MG. Results: MG prevalence was 1.2% [95% confidence interval (CI): 0.7–1.8%] in men and 1.3% (0.9–1.9%) in women. There were no positive MG tests in men aged 16–19, and prevalence peaked at 2.1% (1.2–3.7%) in men aged 25–34 years. In women, prevalence was highest in 16–19 year olds, at 2.4% (1.2–4.8%), and decreased with age. Men of Black ethnicity were more likely to test positive for MG [adjusted odds ratio (AOR) 12.1; 95% CI: 3.7–39.4). For both men and women, MG was strongly associated with reporting sexual risk behaviours (increasing number of total and new partners, and unsafe sex, in the past year). Women with MG were more likely to report post-coital bleeding (AOR 5.8; 95%CI 1.4–23.3). However, the majority of men (94.4%), and over half of women (56.2%) with MG did not report any sexually transmitted infection (STI) symptoms. Men with MG were more likely to report previously diagnosed gonorrhoea, syphilis or non-specific urethritis, and women previous trichomoniasis. Conclusions: This study strengthens evidence that MG is an STI. MG was identified in over 1% of the population, including in men with high-risk behaviours in older age groups that are often not included in STI prevention measures.
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                Author and article information

                Contributors
                Role: Editor
                Journal
                J Clin Microbiol
                J. Clin. Microbiol
                jcm
                jcm
                JCM
                Journal of Clinical Microbiology
                American Society for Microbiology (1752 N St., N.W., Washington, DC )
                0095-1137
                1098-660X
                25 March 2020
                26 May 2020
                June 2020
                26 May 2020
                : 58
                : 6
                : e02124-19
                Affiliations
                [a ]University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, USA
                [b ]Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA
                [c ]Baylor Scott & White Health, Temple, Texas, USA
                [d ]Laboratory Corporation of America Holdings, Burlington, North Carolina, USA
                [e ]Healthcare Clinical Data, Inc., North Miami, Florida, USA
                [f ]Indiana University School of Medicine, Indianapolis, Indiana, USA
                [g ]Planned Parenthood of Southern New England, New Haven, Connecticut, USA
                [h ]Planned Parenthood of St. Louis Region and Southwest Missouri, St. Louis, Missouri, USA
                [i ]Brown University, Providence, Rhode Island, USA
                [j ]University of Mississippi Medical Center, Jackson, Mississippi, USA
                [k ]BioCollections Worldwide, Inc., Miami, Florida, USA
                [l ]Roche Molecular Systems, Inc., Pleasanton, California, USA
                [m ]Quest Diagnostics Infectious Disease, San Juan Capistrano, California, USA
                Marquette University
                Author notes
                Address correspondence to Barbara Van Der Pol, bvanderp@ 123456uab.edu .

                Citation Van Der Pol B, Waites KB, Xiao L, Taylor SN, Rao A, Nye M, Chavoustie S, Ermel A, Kaplan C, Eisenberg D, Chan PA, Mena L, Pacheco S, Krishnamurthy S, Mohan R, Bertuzis R, McGowin CL, Arcenas R, Marlowe EM. 2020. Mycoplasma genitalium detection in urogenital specimens from symptomatic and asymptomatic men and women by use of the cobas TV/MG test. J Clin Microbiol 58:e02124-19. https://doi.org/10.1128/JCM.02124-19.

                Author information
                https://orcid.org/0000-0003-3064-8564
                Article
                02124-19
                10.1128/JCM.02124-19
                7269414
                32213558
                520ae774-52b2-4218-a2a6-6bf756d47645
                Copyright © 2020 Van Der Pol et al.

                This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International license.

                History
                : 9 January 2020
                : 6 February 2020
                : 12 March 2020
                Page count
                supplementary-material: 1, Figures: 1, Tables: 3, Equations: 0, References: 40, Pages: 9, Words: 5436
                Categories
                Bacteriology
                Custom metadata
                June 2020

                Microbiology & Virology
                cobas tv/mg,mycoplasma genitalium,molecular diagnostics,pcr,genital infection,genital disease

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