Validation of an immunologic diagnostic kit for infectious vaginitis by Trichomonas vaginalis, Candida spp., and Gardnerella vaginalis

FemPure is a kit for the rapid diagnosis of vaginitis by Trichomonas vaginalis, Candida spp., and Gardnerella vaginalis, based on aggregation of latex particles joined to specific antibodies. The validation of the method involved the parameters specificity, detection limit, robustness, clinical sensitivity, and clinical specificity. Also, samples analyzed in parallel by the validated test and other recognized tests conducted by external laboratory were included. The method was specific for the 3 infectious agents, and no cross-reaction with other microorganisms usually present in vaginal exudates. The detection limit ≥1 × 106 CFU/mL for Candida albicans and G. vaginalis avoids the detection of concentrations considered normal flora, whereas T. vaginalis was detected until 1 × 105 cells/mL. Values of clinical sensitivity ≥80% and clinical specificity ≥90% and concordance ≥90% were found between samples evaluated in parallel by different methods. Robustness showed that the test can be used in laboratories with different management systems; its simple implementation without equipment allows the use in primary health care areas.