BD Vaginal Panel
Assays

BD Vaginal Panel Together we can elevate the standard of care for vaginitis

The BD Vaginal Panel is the first microbiome-based PCR assay detecting
the three most common infectious causes of vaginitis/vaginosis (V/V)

Challenges of vaginal infections
Overcome testing challenges
Comprehensive design
High sensitivity and specificity
Improve accuracy and patient management

Vaginal infections are common, yet difficult to diagnose, which may lead to inappropriate treatment, continued troublesome symptoms and serious associated risks

Up to 75% of women experience at least one episode of V/V in their lifetime5
Accurate diagnosis of BV, VVC and TV is critical to patient management as each infection requires unique medications and treatment regimens5
Lack of accurate diagnosis methods and variations in clinical practice leave approximately 30% of women undiagnosed despite a clinical visit6

V/V is difficult to diagnose due to symptom overlap7,8 and patient co-infection3

Serious risks include pre-term or low birth-weight babies, late term miscarriage, increased risk of sexually transmitted infection acquisition (including HIV) and pelvic inflammatory disease5
Vaginal infections may cause irritating symptoms that disrupt quality of life and other serious consequences5
Incorrect diagnosis can result in inappropriate treatment, continued symptoms, and repeat physician visits7

Improved diagnostic tools such as the BD Vaginal Panel can help address the testing challenges associated with vaginal infections complexity

  • BV is a polymicrobial infection resulting in an unbalanced vaginal microbiome5
Lactobacillus crispatus
Lactobacillus jensenii
Gardnerella vaginalis
Atopobium vaginae
BVAB - 2
Megasphaera - 1
With BD Vaginal Panel, pathogen selection and comprehensiveness may improve the ability to diagnose this condition
  • VVC can be caused by multiple Candida species, including those with known antifungal resistance9
Common
VVC-causing species
Global
prevalence
Global
Fluconazole
resistance rate
C. albicans 65.3% 1.4%
C. glabrata 11.3% 15.7%
C. tropicalis 7.2% 4.1%
C. parapsilosis 6.0% 3.6%
C. krusel 2.4% 78.3%
C. dubliniensis 0.1% 2.6%
With BD Vaginal Panel, differentiation of C. glabrata and C. krusei from a broad Candida group result helps inform decisions on V/V management, specifically VVC treatment

The BD Vaginal Panel focuses on pathogens that support clinical decision making and patient management for those suffering from vaginitis1

  • First PCR-based panel for vaginitis to receive FDA IVD status via market authorisation that can directly detect organisms associated with infections: bacterial vaginosis (BV), vulvovaginal candidiasis (VVC) and trichomoniasis (TV)
  • Fully integrated on the BD MAX™ System and currently being developed for the BD COR™ System
  • Delivers clear test results that strategically inform therapeutic choices2,3
Bacterial vaginosis
Gardnerella vaginalis
Atopobium vaginae
Megasphaera -1
BVAB -2
Lactobacillus crispatus
Lactobacillus jensenii
+/-
Vulvovaginal candidiasis
Candida group*
Candida glabrata
Candida krusei
+/- +/- +/-
Trichomoniasis
Trichomonas vaginalis
+/-

BD MAX™ System Reports
(Positive or Negative)

*Candida group includes C. albicans, C. parapsilosis, C. tropicalis, C. dubliniensis

The BD Vaginal Panel shows a considerable sensitivity advantage compared to clinician diagnosis, with the added benefit of requiring a single test to achieve these results2

  • Exhibits higher sensitivity and comparable specificity to traditional in-clinic tests2

    Over
    15%

    improvement in sensitivity for BV2

    Over
    33%

    improvement in sensitivity for VVC2

    Over
    27%

    improvement in sensitivity for TV2
  • Provides enhanced specificity compared to the BD Affirm™ VPIII for the detection of organisms associated with BV, along with improved sensitivity for the detection of Candida species4

    Nearly
    15%

    improvement in sensitivity for BV4

    29%

    improvement in sensitivity for VVC4
  • Shows an improvement in detecting co-infections2

The BD Vaginal Panel supports clinical decision making and patient management and provides the opportunity to improve V/V diagnosis compared to traditional in-clinic methods2,3

  • Utilises real-time PCR to obtain greater levels of sensitivity than traditional in-clinic methods and a unique algorithm providing accurate BV results in line with clinical understanding of BV as a polymicrobial condition2,3
  • Able to simultaneously detect organisms associated with BV, VVC, and TV, reducing the need for repeat testing2,3
  • Calls out separately the organisms that may require different treatment for Candidiasis in cases of co-infections which occur in approximately 20% of cases2
  • Clear test results remove the subjectivity associated with many traditional V/V diagnostic tests
  • Results can be obtained in approximately three hours, and up to 24 tests can be performed in a single run
Improved patient management
Improved patient management
Improved patient management
Efficient
workflow
Improved patient management
Accurate, timely results