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Validation of an immunologic diagnostic kit for infectious vaginitis by Trichomonas vaginalis, Candida spp., and Gardnerella vaginalis.
Diagn Microbiol Infect Dis. 2009 Mar; 63(3):257-60.DM

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.

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Authors+Show Affiliations

Bravo AB
National Center for Agricultural Health, San José de la Lajas, La Havana, Cuba. arsenio@censa.edu.cu
Miranda LS
No affiliation info available
Lima OF
No affiliation info available
Cambas AV
No affiliation info available
Hernández ML
No affiliation info available
Alvarez JM
No affiliation info available

MeSH

AnimalsCandidaCandidiasis, VulvovaginalCross ReactionsFemaleGardnerella vaginalisHumansLatex Fixation TestsSensitivity and SpecificityTrichomonas VaginitisTrichomonas vaginalisVaginitisVaginosis, Bacterial

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

19216938

Citation

Bravo, Arsenio Betancourt, et al. "Validation of an Immunologic Diagnostic Kit for Infectious Vaginitis By Trichomonas Vaginalis, Candida Spp., and Gardnerella Vaginalis." Diagnostic Microbiology and Infectious Disease, vol. 63, no. 3, 2009, pp. 257-60.
Bravo AB, Miranda LS, Lima OF, et al. Validation of an immunologic diagnostic kit for infectious vaginitis by Trichomonas vaginalis, Candida spp., and Gardnerella vaginalis. Diagn Microbiol Infect Dis. 2009;63(3):257-60.
Bravo, A. B., Miranda, L. S., Lima, O. F., Cambas, A. V., Hernández, M. L., & Alvarez, J. M. (2009). Validation of an immunologic diagnostic kit for infectious vaginitis by Trichomonas vaginalis, Candida spp., and Gardnerella vaginalis. Diagnostic Microbiology and Infectious Disease, 63(3), 257-60. https://doi.org/10.1016/j.diagmicrobio.2008.11.010
Bravo AB, et al. Validation of an Immunologic Diagnostic Kit for Infectious Vaginitis By Trichomonas Vaginalis, Candida Spp., and Gardnerella Vaginalis. Diagn Microbiol Infect Dis. 2009;63(3):257-60. PubMed PMID: 19216938.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Validation of an immunologic diagnostic kit for infectious vaginitis by Trichomonas vaginalis, Candida spp., and Gardnerella vaginalis. AU - Bravo,Arsenio Betancourt, AU - Miranda,Lilian Sánchez, AU - Lima,Octavio Fernández, AU - Cambas,Alexandra Villoch, AU - Hernández,Maite Lorenzo, AU - Alvarez,Juan Manuel, PY - 2008/07/17/received PY - 2008/11/04/revised PY - 2008/11/20/accepted PY - 2009/2/17/entrez PY - 2009/2/17/pubmed PY - 2009/3/7/medline SP - 257 EP - 60 JF - Diagnostic microbiology and infectious disease JO - Diagn Microbiol Infect Dis VL - 63 IS - 3 N2 - 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. SN - 1879-0070 UR - https://www.unboundmedicine.com/medline/citation/19216938/Validation_of_an_immunologic_diagnostic_kit_for_infectious_vaginitis_by_Trichomonas_vaginalis_Candida_spp__and_Gardnerella_vaginalis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0732-8893(08)00481-1 DB - PRIME DP - Unbound Medicine ER -