Evaluation of the Vaginal Panel Realtime PCR kit (Vircell, SL) for diagnosing vaginitis: A comparative study with routinely used diagnostics

• DOI: 10.1371/journal.pone.0313414
• Publication Date: 2024-11-06T18:29:23Z
• Authors: Isabel Amor; Ana Alberola; Adolfo De Salazar; Laura Viñuela; Sara Úbeda-Portugués; María Isabel Galán; Pablo Mendoza; Federico García
• Keywords: Trichomoniasis; Concordance; Positive predicative value; Trichomonas; Trichomonas Vaginitis; Kappa; Molecular diagnostics; Vaginal disease

Vaginitis is a prevalent clinical disorder associated with several adverse health consequences, prompting women to seek medical care. In this study we evaluate the Vaginal Panel Real-Time PCR kit (qPCR test) against routinely used diagnostics for detection of bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomoniasis. A total 1011 vaginal swab specimens were analyzed. The diagnostic methods BV was Gram stain-based Nugent score. VVC presence detected by culture, Candida species identified using MALDI-TOF MS. Trichomonas vaginalis culture in selective medium. Molecular analyses conducted on MagXtract ® 3200 System analyzed CFX96 ™ Detection System. sensitivity, specificity, positive predictive value, negative value qPCR test compared reference method diagnosis 93.1%, 88.8%, 90.1% 92.2%, respectively, Kappa 0.82. For species, 96.0%, 98.4%, 95.3%, 98.7%, respectively. 32 additional samples not reported diagnostics. trichomoniasis, T . fifteen specimens, despite no microscopic cultured specimens. Our results demonstrate that shows optimal concordance diagnosing vaginitis. Furthermore, enhancing However, further validation studies are necessary confirm its full accuracy. use nucleic acid amplification tests (NAATs) provides rapid accurate diagnosis, crucial early treatment