Diagnosit ® BVBLUE ® / Product Information / Features and Benefits
Diagnosit ® BVBLUE ® / Product Information / Features and Benefits

Features and Benefits

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.

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.

From these studies,

Figure 1. Comparison of Sensitivities of BV Detection Methods vs Gram Stain (Nugent)

ComparisonofBVDetectionMethods

  • 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

CONVENIENT

  • Controlled Room Temperature Storage
  • 12-month shelf life (from date of manufacture)

For In Vitro Diagnostic Use Only. Diagnosit® BVBLUE® is indicated for professional use only and may be used at the point of care and/or in physician’s offices. It is not intended for home use.

Diagnosit® BVBLUE® is a registered trademark of Gryphus Diagnostics, LLC. US patent numbers 6, 512,100; 6,667,161; and 6,812,332.