Clinical Information

The Aptima BV (bacterial vaginosis) assay is intended to aid in the diagnosis of BV in individuals with clinical presentation consistent with vaginitis and/or vaginosis. Vaginitis is characterized by a spectrum of signs and symptoms, including vaginal/vulvar irritation, odor, discharge, and pruritus. Vaginitis may develop as a result of mechanical or chemical irritants (eg, feminine hygiene products, contraceptive materials) or due to a dysbiosis of the microbiota in the vaginal tract. Up to 90% of vaginitis cases are infectious, due to BV, vulvovaginal candidiasis (Candida vaginitis: CV) and/or trichomoniasis (Trichomonas vaginalis: TV). BV, CV, and TV individually account for 22% to 50%, 17% to 39%, and 4% to 35% of vaginitis cases, respectively. BV has been associated with pelvic inflammatory disease, cervicitis, elevated risk of acquisition of sexually transmitted infections (such as chlamydia, gonorrhea, herpes simplex virus, and HIV), spontaneous abortion, and preterm birth.

Bacterial vaginosis 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. A change in the normal vaginal microbiota is associated with the development of multiple signs and symptoms (eg, discharge, vaginal discomfort, and discharge). Diagnosis of BV can alternatively be established based on clinical criteria alone, referred to as Amsel's criteria, which include measuring vaginal pH, assessment for the presence of clue cells (eg, epithelial cells layered with bacterial cells), discharge, and malodor.