Our laboratory has recently sequenced and characterized the human-specific, pore-forming toxin produced by G. vaginalis known as vaginolysin. VLY is a member of the cholesterol-dependent cytolysin family of toxins and recognizes the complement regulatory molecule CD59 on the surface of human cells. We hypothesize that novel antibody-based techniques may be useful for detection and JNJ-31020028 quantification of VLY production. These strategies may represent a substantial improvement in existing methods of BV diagnosis. Furthermore, antibodies generated against VLY may disrupt VLY-CD59 binding, thereby reducing its toxic effects on human cells. Existing methods of diagnosis for BV are suboptimal and frequently underutilized by practitioners. A recent study by Hogan et al. reports that the prevalence of BV among pregnant women varies greatly depending on the diagnostic criteria used. Furthermore, the authors conclude that the methodology employed by most physicians would understate the true prevalence of BV. Established in 1983, Amsel’s criteria are widely accepted as the best available means for diagnosing BV in the clinical setting and require at least three of the following conditions be present: vaginal discharge, amine odor, pH.4.5 and the presence of clue cells. These criteria are complex, somewhat subjective, and necessitate that microscopy equipment be present on site. Moreover, because the vast majority of women with BV are asymptomatic, application of these criteria may be impractical. A study by Keane et al. noted that the Amsel criteria were used by only 65% of clinics in the UK and only 31% of the practitioners utilized all four criteria in their assessment. The Nugent scoring system for interpretation of Gram-stained vaginal smears was put forth in an attempt to standardize diagnosis of BV and increase inter-rater reliability. Scores are assigned to Gram-stained vaginal smears according to the number of specific bacterial morphotypes seen per microscopic 10006 visual field. While the Nugent scoring system exhibits superior sensitivity and specificity compared to the Amsel criteria, its use remains largely restricted to research protocols. Furthermore, questions regarding the risk of potential morbidities and the need for antimicrobial therapy in those women found to have ‘‘intermediate flora’’ GDC-0084 remain unanswered. The sheer prevalence of BV and its associated morbidities justify the exploration and development of improved diagnostic strategies easily incorporated into diverse clinical settings. Several alternative diagnostic methodologies focusing upon the detection of microbial virulence factors produced by the various BV-associated organisms have been proposed in recent years. These include detection of bacterial sialidases, determination of amine levels, and measurement of proline aminopeptidase activity. While these techniques are relatively simple, rapid and inexpensive, they fail to identify the specific microbial pathogens present. A potential role for novel, molecular based techniques for the diagnosis of BV has recently emerged. Importantly, preliminary studies evaluating these PCR-based strategies have provided additional evidence for G. vaginalis as the primary etiologic agent of BV. Menard et al. analyzed 213 vaginal samples from pregnant women using a molecular probes targeting 8 BV related organisms.