Clear vaginitis diagnosis in one test | BD MAX Vaginal Panel

Get objective vaginitis results that strategically inform therapeutic choices.^1-7

The BD Vaginal Panel is a comprehensive diagnostic test that directly detects the 3 most common infectious causes of vaginitis – bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis (TV) – in one test, with one swab.^1-3

BD Vaginal Panel is designed to avoid any confusion related to ambiguous output results by reporting a clear positive or negative result for each condition.

In addition, it provides separate results for Candida glabrata and C. krusei, two Candida species that are known to carry resistance to traditional antibiotics.^1,8

Candida species
differentiation matters

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BD Vaginal Panel is ACCURATE

PCR-based design provides great levels of sensitivity.²
Designed with a proprietary, microbiome-based algorithm for BV that provides an accurate BV result in line with the clinical understanding of BV as a polymicrobial condition.¹
Utilizes the highly sensitive and CDC-recommended diagnostic technology, NAAT for TV detection.^2,9

BD Vaginal Panel is OBJECTIVE

Provides clear results that remove the subjectivity associated with many traditional vulvovaginitis diagnostic tests.¹
Determines a definitive positive or negative BV result for each patient.¹

BD Vaginal Panel is EFFICIENT

Simultaneously detects organisms associated with BV, VVC, and TV to help reduce the need for repeat testing.^1,2
Can detect co-infecting pathogens which may help improve patient management and inform downstream treatment recommendations.¹
Provides separate results for C. glabrata and C. krusei, two Candida species that may not respond to traditional therapeutics.^1,9

BD Vaginal Panel is FAST

Results obtained in approximately 3 hours.²

BD Vaginal Panel was the first FDA-cleared microbiome-based, PCR assay to directly detect BV, VVC, and TV in one test, with one swab.^1-3

BD Vaginal Panel offers higher sensitivity and similar specificity compared to traditional tests.²

Single infections

The BD Vaginal Panel offers a more accurate vaginitis diagnosis as compared to traditional methods. The sensitivity of BD Vaginal Panel ranges from 90.7% to 96.7% while in-clinic tests have a sensitivity of 56 to 77%.²

Comparison of sensitivity and specificity of BD Vaginal Panel vs in-clinic methods²

Condition	Diagnostic method	Sensitivity	Specificity
BV*	BD Vaginal Panel	92.7%	91.5%
	Clinician diagnosis	77.3%^a	92.3%^b
	Amsel's criteria^†	75.6%^a	94.1%^b
VCC	BD Vaginal Panel	90.7%	93.6%
	Clinician diagnosis	56.8%^a	89.2%^c
	Potassium hydroxide wet mount	57.5%^a	89.4%^c
TV	BD Vaginal Panel	96.7%	99.1%
	Clinician diagnosis	68.9%^a	99.1%^b
	Wet mount	69.7%^a	99.5%^b

^*Note: All methods compared to Nugent 0–3 and 7–10 sub-populations as part of study.
^†Amsel’s criteria: vaginal pH > 4.5; clue cells seen on wet mount microscopy; “whiff test”; and thin, homogeneous, grayish, or off-white vaginal discharge
^aP<0.0001 compared to the investigational test.
^bP˃0.05 compared to the investigational test.
^cP<0.0005 compared to the investigational test.

Multiple infections

The BD Vaginal Panel shows a considerable sensitivity advantage compared to clinician diagnosis for the detection of co-infections, with the added benefit of requiring a single test to achieve these results.²

Comparison of sensitivity of BD Vaginal Panel vs clinician diagnosis for the detection of co-infections²

Condition	Diagnostic method	Sensitivity
BV + VVC	BD Vaginal Panel	73.5%
BV + VVC	Clinician diagnosis	17.8%^a
BV + TV	BD Vaginal Panel	92.4%
BV + TV	Clinician diagnosis	21.2%^a
BV + VVC + TV	BD Vaginal Panel	80.0%
BV + VVC + TV	Clinician diagnosis	10.0%^b

^aP<0.0001 compared to the investigational test.
^bP<0.0005 compared to the investigational test.

Compare FDA-cleared
vaginitis tests

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BV, bacterial vaginosis; FDA, food and drug administration; NAAT, nucleic acid amplification test; PCR, polymerase chain reaction; TV, Trichomonas vaginalis; VVC, vulvovaginal candidiasis.

1. BD MAX™ Vaginal Panel Package Insert (P0258).
2. Schwebke JR et al. J Clin Microbiol. 2018;56:e00252–18.
3. Gaydos CA et al. Obstet Gynecol. 2017;130(1):181–9.
4. Broache M et al. Obstet Gynecol. 2021;138:853–9.
5. Brown H and Drexler M. Popul Health Manag. 2020;23(S1):S3–12.
6. Hillier SL et al. Clin Infect Dis. 2021;72(9):1538–43.
7. Miller JM et al. Clin Infect Dis. 2018;67(6):e1–e94.
8. Pfaller MA et al. J Clin Microbiol. 2010; 48(4):1366–77.
9. Workowski KA et al. MMWR Recomm Rep. 2021;70(4):1–187.

Vaginitis diagnosis made simple and clear

Learn more about BD MAX Vaginal Panel.