title: Validation of an immunologic diagnostic kit for infectious vaginitis by Trichomonas vaginalis, Candida spp., and Gardnerella vaginalis.
abstract: 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 > or =1 x 10(6) CFU/mL for Candida albicans and G. vaginalis avoids the detection of concentrations considered normal flora, whereas T. vaginalis was detected until 1 x 10(5) cells/mL. Values of clinical sensitivity > or =80% and clinical specificity > or =90% and concordance > or =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.
authors.affiliation: National Center for Agricultural Health, San José de la Lajas, La Havana, Cuba. arsenio@censa.edu.cu
authors.forename: Arsenio Betancourt
authors.initials: AB
authors.lastname: Bravo
authors.forename: Lilian Sánchez
authors.initials: LS
authors.lastname: Miranda
authors.forename: Octavio Fernández
authors.initials: OF
authors.lastname: Lima
authors.forename: Alexandra Villoch
authors.initials: AV
authors.lastname: Cambas
authors.forename: Maite Lorenzo
authors.initials: ML
authors.lastname: Hernández
authors.forename: Juan Manuel
authors.initials: JM
authors.lastname: Alvarez
mesh_terms: D000818:Animals; D002175:Candida / Q000276:immunology / Q000302:isolation & purification; D002181:Candidiasis, Vulvovaginal / Q000175:diagnosis*; D003429:Cross Reactions; D005260:Female; D006194:Gardnerella vaginalis / Q000276:immunology / Q000302:isolation & purification; D006801:Humans; D007841:Latex Fixation Tests / Q000379:methods; D012680:Sensitivity and Specificity; D014247:Trichomonas Vaginitis / Q000175:diagnosis* / Q000469:parasitology; D014246:Trichomonas vaginalis / Q000276:immunology / Q000302:isolation & purification; D014627:Vaginitis / Q000382:microbiology* / Q000469:parasitology*; D016585:Vaginosis, Bacterial / Q000175:diagnosis* / Q000382:microbiology