New molecular test for diagnosis of vaginitis and vaginosis


A first-of-its-kind multiplex, real-time polymerase chain reaction assay, BD MAX Vaginal Panel, for diagnosing vaginitis

BD announced that the Food and Drug Administration (FDA) has granted marketing clearance for BD MAX Vaginal Panel to detect the most common causes for vaginitis.

BD MAX Vaginal Panel is a molecular test that allows the detection of microorganisms responsible for bacterial vaginosis, trichomoniasis, and vulvovaginal candidiasis—the most common causes of vaginitis

The in vitro diagnostic assay is a first-of-its-kind multiplex, real-time polymerase chain reaction (PCR) assay authorized for the diagnosis of both vaginitis and vaginosis in females that show symptoms of vaginal infections. It utilizes a unique algorithm to determine the ratio of healthy vs. unhealthy bacteria to help improve the diagnosis of bacterial vaginosis. .

Difficulties with the traditional method include the presence of interfering substances in specimens, the larger number of mixed infections, and the subjectivity. The BD MAX Vaginal Panel can help clinicians improve patient management and up workflow efficiency through its multiplex microbiome-based real-time PCR assay.

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