Evaluation of the diagnostic performance of four self-tests for vulvovaginal candidiasis.

Abstract

Objectives: Vulvovaginal candidiasis is the second most common cause of vaginitis among women of childbearing age worldwide and is often self-diagnosed and self-treated by women. However, self-management of vaginal symptoms has been shown to have very poor outcomes. Hence, reliable self-tests are essential for improving the management of VVC. Here, we evaluated and compared the diagnostic performance of four marketed Candida self-tests.

Methods: Remnant diagnostic material was collected from 140 vaginal samples analysed by culture in the Netherlands. This was used in four commercially available Candida self-tests: Candida albicans Rapid Test Beright, StrongStep Candida albicans Antigen Rapid Test, Tigsun VVC-TV-GV Combo Antigen Test and VagiQUICK. Furthermore, DNA was extracted and used to quantify Candida using qPCR. The performance of each test was compared with culture and qPCR results using appropriate statistical methods.

Results: The Beright, StrongStep, Tigsun and VagiQUICK tests exhibited sensitivities of 47.3%, 30.8%, 73.0% and 66.3% and specificities of 100%, 100%, 100% and 97.4%, respectively, compared with culture. Compared with qPCR, the tests exhibited a sensitivity of 43.4%, 60.2%, 60.8% and 54.7% and a specificity of 89.7%, 73.3%, 80.0% and 75.9%, respectively. Sensitivity improved with increasing Candida concentration thresholds.

Conclusions: The investigated self-tests demonstrated varying performances, with both sensitivity and specificity being consistently lower than manufacturer claims. These findings underscore the urgent need for developing and validating more reliable self-tests to support adequate management of women's health. The sensitivity of currently marketed tests is only slightly better than empirical or self-diagnosis, which limits their clinical utility.