BD™ MAX™ Vaginal Panel
The BD MAX™ Vaginal Panel is the most-comprehensive and first FDA market-authorized, microbiome-based, polymerase chain reaction (PCR) assay that directly detects the 3 most common infectious causes of vaginitis - Bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.
Manufacturer: BD™ 443712
DescriptionThe BD MAX™ Vaginal Panel performed on the BD MAX™ System is an automated qualitative in vitro diagnositc test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginities/vaginosis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from: Bacterial vaginosis markers (Individual markers not reported) Lactobacillus spp. (L. crispatus and L. jensenii) Gardnerella vaginalis, Atopobium vaginae, Bacterial Vaginosis Associated Bacteria-2 (BVAB-2), Megasphaera-1, Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), C. glabrata, C. krusei, T. vaginalis. The BD MAX Vaginal Panel is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis.
|BD MAX™ System, BD MAX™ UVE Specimen Collection Kit|
|Bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis|
|BD MAX™ Vaginal Panel Extraction Tubes (24), BD MAX™ Septum Caps (25), BD MAX™ Vaginal Panel Reagent Strips (24), BD MAX™ Vaginal Panel Vaginitis Master Mix (24), BD MAX™ Vaginal Panel Vaginosis Master Mix (24)|
|microbiome-based, polymerase chain reaction (PCR) assay|
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