Logo Cepheid
Demande d’information
Emplacement/Langue

{{headingText}}

{{paragraphText}}

{{continueBtnLabel}}
{{initials}}
Menu principal
Emplacement/Langue

{{headingText}}

{{paragraphText}}

{{continueBtnLabel}}

Demande d’information
Demande d’information
Molecular Testing impacts accurate diagnosis and treatment of Vaginitis

Temps de lecture : 6 min

20 août 2026

SANTÉ COMMUNAUTAIRE ET MONDIALE

Article

New Evidence About Molecular Testing for Vaginitis Diagnosis

Comparison of BD Affirm™ with Xpert® Xpress MVP and BD MAX™ Vaginal Panel 

 

Key Takeaways1

1.     Vaginal infections are common and often overlap.

Nucleic acid amplification tests (NAATs) detected BV in 42,8%, Candida in 28,3%, and TV in 5,1% of women.

2.     Relying on Gardnerella vaginalis alone can over-diagnose BV

False-positive BV diagnoses were seen in women without BV.

3.     Low sensitivity can mean missed infections.

BD Affirm detected only 56,3% of Candida and 42,9% of TV cases identified by NAATs.

4.     Diagnostic accuracy affects treatment decisions.

27,2% of women would have been misdiagnosed if BD Affirm results alone had guided diagnosis

5.     Multiplex NAATs better reflect the complexity of vaginitis.

Multiplex NAATs assess multiple organisms, supporting more reliable differentiation of BV, Candida, and TV.

Vaginitis is a common reason women seek care, yet accurate diagnosis continues to be a challenge in everyday clinical practice. Symptoms often overlap across conditions such as bacterial vaginosis (BV), vulvovaginal candidiasis, and Trichomonas vaginalis (TV), and mixed infections are common.2 As a result, diagnostic limitations can lead to misdiagnosis, inappropriate treatment, and persistent symptoms.

A recent peer-reviewed study by Cosentino et al.1 provides new insight into this challenge by comparing a widely used non-amplified molecular test, BD Affirm™ VPIII, with two FDA cleared nucleic acid amplification tests (NAATs): Xpert® Xpress MVP (multiplex vaginal panel) and BD MAX™ Vaginal Panel. The findings raise important considerations for clinicians who rely on older probe-based testing or who are evaluating the role of NAATs in vaginitis workups.

How was the study structured?

Infographic showing study overview

Infographic showing study overview

How prevalent were the vaginitis infections?1

Figure 2. Prevalence of infections based on concordant NAAT results.

Prevalence of infections based on concordant NAAT results. ^Candida albicans, C. tropicalis, C. dubliniensis, and C. parapsilosis

Were mixed infections observed?1

Combinations of BV & TV, BV & Candida, Candida & TV, and all 3 were seen 14% of the time by NAAT testing. 

 

Distribution of vaginal infections. See Table 2 of Cosentino et al.1

Distribution of vaginal infections. See Table 2 of Cosentino et al.1

These findings highlight how frequently vaginal infections—including mixed infections occur in routine care settings.

 

How Did BD Affirm Perform vs NAATs?1

The study found that BD Affirm VPIII performance varied by organism, with several clinically meaningful limitations.

Performance of BD Affirm compared to NAATs. See Table 3 of Cosentino et al.1

Performance of BD Affirm compared to NAATs. See Table 3 of Cosentino et al.1

BV: The Limits of a Single Surrogate

BD Affirm detects Gardnerella vaginalis and reports it as a surrogate marker for BV. While sensitivity appeared relatively high, reliance on Gardnerella alone led to false-positive BV results in women without BV, consistent with prior studies.3-7 GV can be present in women with a healthy, Lactobacillus-dominant microbiome and does not, by itself, define BV.

In contrast, the NAATs evaluated in this study detect multiple BV-associated organisms —an approach designed to better reflect the complexity of BV.

Candida & TV: Missed Diagnoses Matter

While positive results were usually correct, nearly half of Candida infections detected by NAATs were missed by BD Affirm. False-negative Candida results can potentially delay appropriate antifungal therapy and prolong patient symptoms.

More than half of TV cases identified by NAATs were missed by BD Affirm. Because TV is sexually transmitted and requires partner treatment to prevent reinfection,8 missed diagnoses carry broader public health implications.

Impact on Patient Management

Cosentino and team reported that 27,2 % of women could have received treatment based on an inaccurate diagnosis if BD Affirm VPIII alone had guided care.1

This included women without BV who would have been unnecessarily treated due to false positive GV results, as well as women with Candida or TV who would have been told no pathogen was detected. Misdiagnosis of vaginal infections could lead to inappropriate treatment, with potential consequences for symptom resolution, antimicrobial usage, and cost.

 

What This Means for Clinical Practice

Quote - Cosentino et al., 2026

Women presenting with vaginitis deserve timely, accurate diagnoses that support appropriate treatment decisions.

For practices still relying on non-amplified probe-based testing, these findings offer an opportunity to reassess diagnostic strategies in light of growing evidence about NAAT performance and clinical impact.

Is your practice aligned with current evidence-based testing strategies for vaginitis?

Click here to learn more about the Xpert Xpress MVP PCR test for detecting 3 common causes of vaginitis, or contact a Cepheid expert to continue the conversation. 

 

 

DMDIV. In vitro diagnostic medical device. Non disponible dans tous les pays. Xpert Xpress MVP is available for lab use and in facilities operating under a CLIA certificate of waiver.

 

Le contenu présenté sur cette page est destiné à des fins informatives et éducatives. Bien qu’elle soit disponible à l’échelle mondiale, elle peut refléter les pratiques cliniques ou les considérations du système de santé spécifiques à une région particulière.

 

Références :

1. Cosentino LA et al., 2026.  Comparing BD Affirm VPIII to Xpert Xpress MVP and BD MAX Vaginal Panel for the diagnosis of vaginal infections. Microbiol Spectr. 2026 Jul 28:e0235325. doi: 10.1128/spectrum.02353-25. Epub ahead of print. PMID: 42517635

2. Qi W et al. 2021. Recent Advances in Presentation, Diagnosis and Treatment for Mixed Vaginitis. Front Cell Infect Microbiol. Nov 2;11:759795. doi: 10.3389/fcimb.2021.759795. PMID: 34796129; PMCID: PMC8592905.

3. Srinivasan S, Fredricks DN. 2008. The human vaginal bacterial biota and bacterial vaginosis. Interdiscip Perspect Infect Dis 750479. doi:10.1155/2008/750479

4. Cartwright CP, et al. 2013. Comparison of nucleic acid amplification assays with BD Affirm VPIII for diagnosis of vaginitis in symptomatic women. J Clin Microbiol 51(11):3694-9

5. Thompson A et al. 2020. Diagnostic 311 performance of two molecular assays for the detection of vaginitis in symptomatic 312 women. Eur J Clin Microbiol Infect Dis 39(1):39-44

6. Richter SS et al. 2019. Prospective evaluation of molecular assays for diagnosis of vaginitis. J Clin Microbiol 58(1):e01264-19

7. Dessai F, Nyirenda M, Sebitloane M, Abbai N. 2020. Diagnostic evaluation of the BD Affirm VPIII assay as a point-of-care test for the diagnosis of bacterial vaginosis, trichomoniasis and candidiasis. Int J STD AIDS 31(4):303-11

8. U.S. Centers for Disease Control and Prevention. About Trichomoniasis https://www.cdc.gov/trichomoniasis/about/index.html Accessed April 2026

Cet article a-t-il été utile ?

Lire la suite

PLUS

Vous entrez sur le site web Français de Cepheid

Les produits présentés sont marqués CE-IVD. Dispositifs médicaux de diagnostic in vitro.

Je certifie être un professionnel de santé:

Powered by Translations.com GlobalLink Web SoftwarePowered by GlobalLink Web