Diagnosit BVblue

Diagnosit BVBLUE is an enzyme activity test for use in the detection of vaginal fluid specimens for sialidase activity, an enzyme produced by bacterial pathogens such as Gardnerella vaginalis, Bacteroides spp., Prevotella spp., and Mobiluncus spp. The Diagnosit BVBLUE test is indicated for use in women suspected of having Bacterial vaginosis (BV) infection, e.g., women with vaginal discharge typical of BV and/or women with previous history of BV, as an aid in the diagnosis of BV infection. Features and Benefits ACCURATE: Independent investigators evaluated the performance of Diagnosit BVBLUE and other BV detection methods, including wet mount, in the clinical diagnosis of bacterial vaginosis in 840 women. Diagnosit BVBLUE was found to be more sensitive than wet mount Diagnosit BVBLUE exhibited 92.8% sensitivity. Wet mount exhibited 71.0% sensitivity. Diagnosit BVBLUE was found to be more specific than wet mount . Diagnosit BVBLUE exhibited 98.0% specificity. Wet mount exhibited 89.5% specificity. Diagnosit BVBLUE was found to be more accurate than wet mount Diagnosit BVBLUE exhibited 96.4% overall accuracy. Wet mount exhibited 84.6% overall accuracy. OBJECTIVE: Instant color change for easy-to-read results. FAST: Less than 1 minute hands-on-time 10 minutes to a test result EASY TO USE CLIA: Waived Internal Controls External Controls Available Accurate & Comprehensive Diagnosit BVBLUE detects Sialidase enzyme in vaginal fluid specimens. Sialidase is secreted by pathogens associated with bacterial vaginosis including Gardnerella vaginalis, Bacteroides spp., Prevotella spp., and Mobiluncus spp. Performance compared to Gram Stain: 93% Sensitivity / 98% Specificity / 96% Accuracy “Sialidase activity and Gram stain of vaginal fluid represent accurate methods for diagnosing BV” Smayevsky et. al. Infectious Diseases in Obstetrics and Gynecology 2001; 9: 17-22. Convenient: Test and Treat - Less than 1 minute hands-on-time … 10 minutes to a test result in one office visit No Specialized Training - CLIA Waived – Low risk of erroneous result Convenient Storage - Controlled Room Temperature Storage Convenient Packaging - All necessary components to conduct 25 tests (including swabs) Strong Reimbursement: Larger Gross Margin Potential than other clinical methods of diagnosing BV BVBLUE animated test procedure: https://www.youtube.com/watch?v=y0BH7m2nqcU Sialidases, Pregnancy, and BV Sialidases (EC 3.2.1.18) are of considerable importance in women’s health in that they have been shown to act in a way that enhances the attachment of bacteria to mucosal tissue (i.e., thin membrane that lines the urogenital system in this case) thereby allowing the invasion of the bacteria and destruction of the mucosal tissue. This is done through the breakage of sialic acid residues from sialylglycoconjugates. In fact, sialidases have been identified as a virulence factor in the infection of many bacteria including Gardnerella vaginalis, Bacteroides spp., Prevotella spp., and Mobilucus spp., bacterial pathogens associated with Bacterial Vaginosis (BV). Recent advancements in clinical medicine have demonstrated a clear association between the presence of e levated vaginal fluid sialidases and an increased risk of pre-term birth. Why Should I Test for BV! Common Infection - Bacterial vaginosis is the most common vaginal infection in women aged 15 – 44 years (CDC.gov – BV – Fact Sheet) Bacterial vaginosis accounts for 60 million patient visits worldwide: Prevalence in Low Risk Populations = 10% Prevalence in High Risk Populations = 64% In most populations, BV is: 2 to 4 times more prevalent than Candida 5 to 8 times more prevalent than Trichomoniasis BV represents 45% of all vulvovaginal infections Clinically Significant - Implications and Complications Found in 60% of women who have an STD (RxList.com – BV) Undiagnosed BV can lead to: HIV acquisition and transmission Acquisition of HSV-2 Gonorrhea Chlamydial infection Other STDs Pelvic Inflammatory Disease (PID) Endometritis Post-Hysterectomy Infections Recurrent Urinary Tract Infections (UTIs) Placental Infection Premature Rupture of Membranes (PROM) Preterm Birth Delivery of a Low-Birth-Weight Infant Spontaneous Loss of Pregnancy Asymptomatic - In clinical studies, Bacterial Vaginosis was found to be asymptomatic in 84% of women found to have BV Recurrent - Recurrent within 12 months in 50% of cases