BMC women's health · 2026
Clinical evaluation of Candida albicans enolase 1 as a novel biomarker for vulvovaginal candidiasis: a pilot study demonstrating rule-out capability.
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Meng Hanbing, Xing Huimin, Sun Qingqing, Li Fang, He Zhengxin
Аннотация
PURPOSE: Vulvovaginal candidiasis (VVC) affects approximately 75% of women during their lifetime, yet current diagnostic methods have limitations. This pilot study evaluated Candida albicans enolase 1 (CaEno1) as a diagnostic biomarker for C. albicans-associated VVC, with a view to informing future point-of-care test (POCT) development.
METHODS: A total of 131 vaginal secretion samples were collected from patients presenting with vulvovaginal symptoms at a gynecology department. Samples underwent routine microscopic examination, fungal culture, and CaEno1 detection using a previously developed double-antibody sandwich ELISA (DAbS-ELISA) with sensitivity of 0.33 ng/mL. ROC curve analysis determined optimal diagnostic performance parameters.
RESULTS: Among 131 samples, 33 (25.2%) showed positive fungal growth, with C. albicans predominating (72.7% of positive cultures). CaEno1 levels were significantly higher in C. albicans-positive samples compared to negative samples (Mann-Whitney U test, P < 0.0001). ROC analysis yielded an area under the curve of 0.727 (95% CI: 0.613-0.842). At an optimal cutoff value of 0.052 optical density units at 450 nm (OD450), the assay demonstrated 70.8% sensitivity, 78.5% specificity, 42.5% positive predictive value (PPV), and 92.3% negative predictive value (NPV).
CONCLUSION: This study provides the first clinical evidence that CaEno1 can be detected in vaginal secretions and suggests potential rule-out utility for Candida-associated VVC in settings where C. albicans predominates. The favorable NPV observed in this cohort supports its potential use as a screening tool in comparable clinical settings, though cross-reactivity with non-albicans species warrants cautious interpretation alongside clinical findings.
METHODS: A total of 131 vaginal secretion samples were collected from patients presenting with vulvovaginal symptoms at a gynecology department. Samples underwent routine microscopic examination, fungal culture, and CaEno1 detection using a previously developed double-antibody sandwich ELISA (DAbS-ELISA) with sensitivity of 0.33 ng/mL. ROC curve analysis determined optimal diagnostic performance parameters.
RESULTS: Among 131 samples, 33 (25.2%) showed positive fungal growth, with C. albicans predominating (72.7% of positive cultures). CaEno1 levels were significantly higher in C. albicans-positive samples compared to negative samples (Mann-Whitney U test, P < 0.0001). ROC analysis yielded an area under the curve of 0.727 (95% CI: 0.613-0.842). At an optimal cutoff value of 0.052 optical density units at 450 nm (OD450), the assay demonstrated 70.8% sensitivity, 78.5% specificity, 42.5% positive predictive value (PPV), and 92.3% negative predictive value (NPV).
CONCLUSION: This study provides the first clinical evidence that CaEno1 can be detected in vaginal secretions and suggests potential rule-out utility for Candida-associated VVC in settings where C. albicans predominates. The favorable NPV observed in this cohort supports its potential use as a screening tool in comparable clinical settings, though cross-reactivity with non-albicans species warrants cautious interpretation alongside clinical findings.