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Purpose <p>Vulvovaginal candidiasis (VVC) affects approximately 75% of women during their lifetime, yet current diagnostic methods have limitations. This pilot study evaluated <i>Candida albicans</i> enolase 1 (CaEno1) as a diagnostic biomarker for <i>C. albicans</i>-associated VVC, with a view to informing future point-of-care test (POCT) development.</p> Methods <p>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.</p> Results <p>Among 131 samples, 33 (25.2%) showed positive fungal growth, with <i>C. albicans</i> predominating (72.7% of positive cultures). CaEno1 levels were significantly higher in <i>C. albicans</i>-positive samples compared to negative samples (Mann-Whitney U test, <i>P</i> &lt; 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&#xa0;nm (OD450), the assay demonstrated 70.8% sensitivity, 78.5% specificity, 42.5% positive predictive value (PPV), and 92.3% negative predictive value (NPV).</p> Conclusion <p>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.</p>

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Clinical evaluation of Candida albicans enolase 1 as a novel biomarker for vulvovaginal candidiasis: a pilot study demonstrating rule-out capability

  • 期刊论文

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  • 发表日期：

    2026年7月6日

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  • Hanbing Meng,
  • Huimin Xing,
  • Qingqing Sun,
  • Fang Li,
  • Zhengxin He

摘要

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.