Vaginal PRA1 identifies clinically relevant Candida albicans vaginitis and excludes asymptomatic colonization: an...

Area of Science:

• Gynecology
• Infectious Diseases
• Clinical Diagnostics

Background:

• Distinguishing Candida infection from colonization in women with vulvovaginal symptoms is challenging.
• Candida albicans secreted protein Pra1 drives inflammatory immunopathology in vulvovaginal candidiasis (VVC).
• Vaginal PRA1 expression may serve as a biomarker to differentiate active disease from commensal colonization.

Purpose of the Study:

• To evaluate vaginal PRA1 as a diagnostic biomarker for symptomatic Candida vaginitis.
• To assess the correlation between PRA1 levels, Candida detection, and symptom severity.

Main Methods:

• Prospective exploratory biomarker analysis in 9 women with vulvovaginal symptoms over 12 weeks.
• Collected cervicovaginal lavage samples for Candida culture and PRA1 quantification via qPCR.
• Clinical severity score (CSS) and symptom data were recorded; symptomatic vaginitis defined as culture-positive with CSS ≥ 3.

Main Results:

• PRA1 concentrations were significantly higher in Candida culture-positive samples compared to culture-negative samples (median 4,011 vs. 21.5 pg/µL).
• PRA1 levels were substantially elevated in symptomatic vaginitis cases versus asymptomatic colonization (median 11,762 vs. 21.5 pg/µL).
• PRA1 demonstrated high diagnostic accuracy (AUC ~0.95) for both Candida positivity and symptomatic vaginitis, correlating with symptom severity.

Conclusions:

• Vaginal PRA1 shows promise as a biomarker to distinguish symptomatic Candida-associated disease from mere Candida detection.
• PRA1 may be particularly useful as a rule-out biomarker for clinically significant Candida vaginitis.
• These findings are preliminary and require validation in larger cohorts.