Epidemiological and clinical rationale for screening and diagnosis of Mycoplasma genitalium infections.

1. Chris L. McGowin, PhD[⇑][1] 1. Louisiana State University Health Sciences Center, Department of Microbiology, Immunology and Parasitology, New Orleans, LA 2. Rodney E. Rohde, PhD, MS, SV, SM(ASCP)CM, MBCM 1. Clinical Laboratory Science Program, College of Health Professions, Texas State University, San Marcos, TX 3. Gerald Redwine, MEd, MT(ASCP) 1. Clinical Laboratory Science Program, College of Health Professions, Texas State University, San Marcos, TX 1. Address for Correspondence: Chris L. McGowin, PhD, Louisiana State University Health Sciences Center, Department of Microbiology, Immunology and Parasitology, 1901 Perdido St.; MEB 6214, New Orleans, LA 70112-2822, 504 568-7281, cmcgow{at}lsuhsc.edu 1. Discuss the historical and epidemiological background of Mycoplasma genitalium 2. Justify the clinical rationale for M. genitalium testing 3. Describe the diagnosis of M. genitalium 4. Define M. genitalium non-gonococcal urethritis and cervicitis 5. Explain the syndromic management and antimicrobial resistance associated with M. genitalium Mycoplasma genitalium has been the focus of basic scientific and synthetic biology research as the organism with the smallest genome of all known human bacterial pathogens. As a sexually transmitted organism, substantial clinical and epidemiologic evidence now exists that warrant further consideration of M. genitalium as a priority for diagnostic testing. In the early 1980's, M. genitalium was first identified from two men with symptomatic non-gonococcal urethritis (NGU) – an inflammatory syndrome most often attributed to infections with Neisseria gonorrhoeae or Chlamydia trachomatis . Since then, epidemiologic studies of clinical disease, several animal models, and the results of many basic scientific investigations point towards M. genitalium as a urogenital pathogen with significant implications for reproductive and sexual health. It is now unequivocally known that M. genitalium is found in approximately 15-25% of patients with NGU and in more than one third of non-chlamydial NGU cases.1 Importantly, M. genitalium establishes both acute and chronic infections in the urogenital tract of men and women. This article aims to concisely address the rationale for continued investigation of M. genitalium as a sexually transmitted infection (STI) and for the implementation of diagnostic testing paradigms in the USA. Epidemiology of M. genitalium As an emerging urogenital pathogen, the vast majority of M. genitalium research has been focused on the epidemiologic characteristics and associations with disease syndromes – first in men, and more recently in women. With regard to the “emergence” of M. genitalium infections, it should be clarified that no reports have indicated an increase in… ABBREVIATIONS: CDC - Centers for Disease Control and Prevention, FDA - Food and Drug Administration, HPV - Human Papilloma Virus, LDT - laboratory developed tests, MDx - molecular diagnostics, NAAT - nucleic acid amplification test, NGU - non-gonococcal urethritis, NPV - negative predictive value, PPV - positive predictive value, RUO - research use only, STD - sexually transmitted disease, STI - sexually transmitted infection, ART - anti-retroviral therapy, LOD, limit of detection, LOQ, limit of quantification 1. Discuss the historical and epidemiological background of Mycoplasma genitalium 2. Justify the clinical rationale for M. genitalium testing 3. Describe the diagnosis of M. genitalium 4. Define M. genitalium non-gonococcal urethritis and cervicitis 5. Explain the syndromic management and antimicrobial resistance associated with M. genitalium [1]: #corresp-1