Molecular Diagnosis of Sexually Transmitted Infections: A Diverse and Dynamic Landscape

Abstract

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 More than 300 million curable sexually transmitted infections (STIs) are acquired each year worldwide1 making these infections a significant public health and economic concern. At least 25 urogenital and reproductive tract diseases have infectious etiologies that are transmitted through sexual contact and the CDC conservatively estimates approximately 110 million STIs exist among American men and women.2 The roughly 20 million incident cases in the USA alone have direct costs for treatment that top more than $15 billion.2,3 Sexually transmitted pathogens are extraordinarily adapted to life in the urogenital tract. This is exemplified by the fact that all STIs can persist long-term in the face of extensive and complex host innate and adaptive immune responses. This is particularly true in females who disproportionately bear the prevalence and pathological sequelae of STIs with inflammatory syndromes like pelvic inflammatory disease (PID), tubal infertility and several pregnancy-related complications such as preterm birth and spontaneous abortion. Polymicrobial syndromes like bacterial vaginosis and some cases of PID are now recognized as significant medical concerns and have also contributed directly to our understanding of the microbiome and its impact on reproductive health. This FOCUS series of articles has been dedicated to three organisms that creatively illustrate the spectrum and importance of molecular diagnostics (MDx) for STIs: Mycoplasma genitalium , Human Papilloma Virus (HPV), and Trichomonas vaginalis . The last twenty years have been dynamic and exciting for the field of molecular diagnostics. Since the introduction of the first FDA-approved nucleic acid amplification test (NAAT) for C. trachomatis and N. … ABBREVIATIONS: CDC - Centers for Disease Control and Prevention, CT/NG - C. trachomatis and N. gonorrhoeae, FDA - Food and Drug Administration, HPV - Human Papilloma Virus, LDT - laboratory-developed test; MDx - molecular diagnostics, NAAT - nucleic acid amplification test, NGU - non-gonococcal urethritis, PCR - polymerase chain reaction, PID - pelvic inflammatory disease, POC - point of care, STD - sexually transmitted disease, STI - sexually transmitted infection, TMA - transcription mediated amplification [1]: #corresp-1