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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. BVBLUE 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. BVBLUE test results should be considered in conjunction with other clinical and patient information (see Limitations of the Procedure). For In Vitro Diagnostic Use Only. BVBLUE is indicated for professional use only and may be used at the point of care and/or physician's offices. It is not intended for home-use.

BVBLUE is an enzyme activity test for use in the detection of vaginal fluid specimens for sialidase activity.