Evaluation of The Efficacy of Rapid Diagnostic Tests For Trichomonas and Bacterial Vaginitis.

Tawfik, Waleed M; Aboelela, Heba M; Abdelhamid, Hasnaa S.; Sharaf, Abdelbar M.

doi:10.21608/puj.2025.355302.1283

Evaluation of The Efficacy of Rapid Diagnostic Tests For Trichomonas and Bacterial Vaginitis.

Articles in Press

Document Type : Original Article

Authors

¹ Department of Obstetrics & Gynecology, Faculty of Medicine, Benha University, Benha, Egypt.

² Department of Parasitology, Faculty of Medicine, Benha University, Benha, Egypt.

³ Department of Medical Microbiology and Immunology, Faculty of Medicine, Benha University, Benha, Egypt.

⁴ Department of Obstetrics & Gynecology, Faculty of Medicine, Menoufia University, Menoufia, Egypt.

10.21608/puj.2025.355302.1283

Abstract

Background: Mixed trichomonas vaginitis (TV) and bacterial vaginosis (BV) seriously affect females’ reproductive and sexual health. Misdiagnosis may predispose to continued symptoms and inappropriate treatment. This necessitated trials to evaluate the diagnostic performance of simple tests to rapidly and accurately diagnose vulvovaginitis (VV).
Objectives are the evaluation of the diagnostic yield of the OSOM® Trichomonas Rapid Test and the Comprehensive 4-Parameter (C-4-P) Test for TV and BV, respectively in women with VV.
Patients & Methods: vaginal swabs of 85 non-pregnant women with VV were obtained. Diagnosis of TV depended on anaerobic broth culturing of the swab and for BV on the Nugent scoring system for Gram-stained vaginal smear. The OSOM® test utilizes the capillary-flow dipstick technology for rapid detection of T. vaginalis antigen. The C-4-P test depends on the colorimetric detection of the activity levels of sialidase and leukocyte esterase and the determination of vaginal pH and H2O2 levels.
Results: The culture detected 8 positive specimens for trichomoniasis (9.4%). The OSMO test showed 100% specificity and positive predictive value (PPV), with an 87.5% sensitivity and 98.72% negative predictive value (NPV), and 98.82% accuracy rate. The Nugent scoring system defined 25 negative, 39 intermediate, and 21 positive smears for BV. The C-4-P test differentiated the intermediate smears as 27 positives and 12 negatives and showed sensitivity and specificity rates of 95.24% and 92%, respectively with PPV and NPV of 90.91 and 93.48 and 93.48% accuracy rate for BV diagnosis.
Conclusion: The OSOM and the C-4-P rapid tests provided high diagnostic performance for TV and BV with accuracy rates of 98.82% and 93.48%, respectively, and thus might spare the need for the culture and molecular methods to save time and resources.

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