BD MAX™ Vaginal Panel
Assays

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

The BD MAX™ 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 lifetime1
Accurate diagnosis of BV, VVC and TV is critical to patient management as each infection requires unique medications and treatment regimens1
Lack of accurate diagnosis methods and variations in clinical practice leave approximately 30% of women undiagnosed despite a clinical visit2

V/V is difficult to diagnose due to symptom overlap3,4 and patient co-infection5

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 disease1
Vaginal infections may cause irritating symptoms that disrupt quality of life and other serious consequences1
Incorrect diagnosis can result in inappropriate treatment, continued symptoms, and repeat physician visits3

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

  • BV is a polymicrobial infection resulting in an unbalanced vaginal microbiome1
Lactobacillus crispatus
Lactobacillus jensenii
Gardnerella vaginalis
Atopobium vaginae
BVAB - 2
Megasphaera - 1
With BD MAX™ 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 resistance6
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 MAX™ 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 MAX™ Vaginal Panel focuses on pathogens that support clinical decision making and patient management for those suffering from vaginitis7

  • 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 choices5,8
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 MAX™ Vaginal Panel shows a considerable sensitivity advantage compared to clinician diagnosis, with the added benefit of requiring a single test to achieve these results8

  • Exhibits higher sensitivity and comparable specificity to traditional in-clinic tests8

    Over
    15%

    improvement in sensitivity for BV8

    Over
    33%

    improvement in sensitivity for VVC8

    Over
    27%

    improvement in sensitivity for TV8
  • 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 species9

    Nearly
    15%

    improvement in sensitivity for BV9

    29%

    improvement in sensitivity for VVC9
  • Shows an improvement in detecting co-infections8

The BD MAX™ Vaginal Panel supports clinical decision making and patient management and provides the opportunity to improve V/V diagnosis compared to traditional in-clinic methods6,7

  • 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 condition6,7
  • Able to simultaneously detect organisms associated with BV, VVC, and TV, reducing the need for repeat testing6,7
  • Calls out separately the organisms that may require different treatment for Candidiasis in cases of co-infections which occur in approximately 20% of cases6
  • 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