Clinical Summary

Vaginitis syndrome is characterized by a spectrum of conditions: vaginal and vulvar irritation, odor, discharge, and pruritus. Causes of vaginitis include mechanical and chemical factors (feminine hygiene products, contraceptive materials, etc.) as well as infectious agents. Up to 90% of infectious vaginitis cases are caused by BV, vulvovaginal candidiasis (candida vaginitis, CV) and trichomoniasis (trichomonas vaginalis vaginitis, TV) . BV has been diagnosed in 22-50% of symptomatic patients, CV in 17-39%, and TV in 4-35%.

BV is responsible for the majority of infectious vaginitis cases. BV is characterized by a change in the vaginal microbiota dominated by Lactobacillus species to a polymicrobial anaerobe-dominated microbiota that includes Gardnerella vaginalis, Atopobium vaginae, Prevotella, Bacteroides, Peptostreptococcus, Mobiluncus, Sneathia (Leptotrichia), Mycoplasma, and BV associated bacteria. This change in vaginal microbiota is associated with the onset of Amsel clinical signs, resulting from the biochemical and cytological changes in the vaginal mileu that are pathognomonic for BV. BV has been associated with pelvic inflammatory disease, cervicitis, elevated risk of acquisition of STIs, such as chlamydia, gonorrhea, HSV, HIV, spontaneous abortion, and preterm birth. Diagnosis of BV based on clinical criteria (vaginal pH, presence of clue cells, whiff test, and discharge) has been proposed by Amsel. Nugent et al. proposed a classification for BV based on microscopic description of observed types of bacteria via Gram stain in vaginal swabs. Recent studies suggest that molecular diagnostic tools would be beneficial to improve diagnosis of BV and that nucleic acid amplification, targeting several BV-associated bacteria, could be utilized. The Aptima BV assay is a real time TMA assay developed for use on the automated Panther system that detects and discriminates RNA markers from the Lactobacillus species group (L. gasseri, L. crispatus and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae in clinician-collected and patient-collected vaginal swab specimens from symptomatic females.The Aptima BV assay uses an algorithm to report a qualitative result for BV based on detection of target organisms.

CV, commonly known as a yeast infection, is the second and most frequent cause of vaginitis. CV is characterized by an overgrowth of Candida species in the vaginal tract and is associated with clinical signs of inflammation. Up to 89% of CV cases are caused by C.albicans, while non-albicans species may be responsible for 11%. Characteristic symptoms for CV include abnormal vaginal discharge, vaginal soreness, pruritus, dyspareunia, and external dysuria . C. glabrata, which is responsible for the majority of non-albicans CV in the U.S., may have decreased susceptibility to standard antimycotic therapeutic intervention compared to C. albicans. C. glabrata infections therefore require special attention in clinical management.

TV is the third most common cause of infectious vaginitis. The causative agent, the protozoan parasite TV, is transmitted by unprotected penile-vaginal sex. Women infected with TV during pregnancy have increased risk for adverse pregnancy outcomes, such as premature rupture of membranes, preterm delivery, and low birth weight. TV infection is associated with an increased risk of HIV acquisition and transmission, as well as prolonged HPV infection and concurrent sexually transmitted infections (chlamydia, gonorrhea, and herpes simplex virus types 1 & 2). CV and TV may be detected by microscopy, culture, and nucleic acid using specimens collected with vaginal swabs. The Aptima CV/TV assay is a real time TMA assay developed for use on the automated Panther system that detects and discriminates RNA markers from C spp, C. glabrata, and TV