Abstract
There is an ongoing need for an accurate, affordable, and simple point of care test to detect Bacterial Vaginosis (BV). This condition is characterized as a change from a Lactobacillus‐dominant vaginal microbiota to an anaerobic and facultative bacterial dominance, leaving patients with vaginal discharge, vaginal malodor, and extreme discomfort. The effects of BV are substantial, and include increased risks of acquiring a sexually transmitted infection, and the increased likelihood of miscarriages associated with BV. These potential outcomes of BV negatively and acutely impact the patient's quality of life, while these individuals also often report physical discomfort, embarrassment, and social isolation as a result of undiagnosed BV. To date, the most commonly identified bacteria associated with BV is Gardnerella vaginalis. This work describes the design of a diagnostic test for the presence of vaginolysin, a toxin secreted by all 17 strains of G. vaginalis. Quantification of this toxin can be correlated with levels of this undesired bacteria, while elevated levels of G. vaginalis have been shown to lead to a toxic vaginal environment, facilitating BV. We report the recombinant expression and purification of vaginolysin, and the development of an ELISA assay for its detection. This methodology will, in turn, be adapted to a lateral flow assay (LFA) for use in a rapid, easy‐to‐use, cost effective paper‐based point‐of‐care diagnostic for BV that does not require the use of any instrumentation for the visualization of the results of the test. The platform that we have devised is amenable for the incorporation of other assays, and, therefore, can be employed for the multiplex detection of other pathogens. Specifically, our approach and detection platform will be expanded to include tests for Lactobacillus, Mobiluncus, Prevotella, Bacteroides, Peptostreptococcus, and the seven other bacteria that leave the vagina in an unbalanced state, ultimately providing for a fully comprehensive point‐of‐care test to detect bacterial vaginosis.
Support or Funding Information
Dr. Sylvia Daunert is grateful to the Miller School of Medicine of the University of Miami for the Lucille P. Markey Chair in the Department of Biochemistry and Molecular Biology.
Principal Behind the Lateral Flow Assay for Vaginolysin
This is from the Experimental Biology 2018 Meeting. There is no full text article associated with this published in The FASEB Journal.