Qualitative DNA Testing of the Bacteria Causing Vaginal Inflammation - Vietnam Registration 2301123ĐKLH/BYT-HTTB

BD MAX™ Vaginal Panel is performed on the BD MAX System and is an in vitro qualitative automated diagnostic test that directly detects the target DNA from bacteria associated with bacterial vaginosis (the qualitative results are reported based on the detection and quantification of the target biological markers), Candida species associated with Candida vaginitis and Trichomonas vaginalis from vaginal swabs of symptomatic patients with signs of bacterial vaginosis / vaginitis. The test uses real-time polymerase chain reaction (PCR) to amplify the specific target DNA and uses target-specific fluorescent probe samples to detect and differentiate DNA from: •Bacterial vaginosis-associated markers (not reporting individual markers) Lactobacillus spp. (L. crispatus and L. jebenii) Gardnerella vaginalis Atopobium vaginale Bacterial Vaginosis Associated Bacteria-2 (BVAB-2) Megasphaera-1. •Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniebis) •Candida glabrata •Candida krusei •Trichomonas vaginalis BD MAX Vaginal Panel aims to support the diagnosis of vaginitis in women with clinical signs consistent with bacterial vaginosis, Candida vaginitis and trichomoniasis.