Operational characteristics of the clinical diagnosis in the office, with and without tests (pH and amine test), for diagnosing bacterial vaginosis in symptomatic patients in Bogotá, Colombia
DOI:
https://doi.org/10.18597/rcog.292Keywords:
Bacterial vaginosis, diagnosis, “Clinical Laboratory Techniques”, “sensitivity and specificity”Abstract
Objective: To assess the operational characteristics of the clinical diagnosis (signs and symptoms) alone and with diagnostic tests in the office (pH and amine test), using the Nugent score as the gold standard for diagnosing bacterial vaginosis.
Materials and methods: Diagnostic validity study assembled in a cross sectional study in patients with symptoms of lower genitourinary tract infection seen in 3 centres in Bogota in 2010. The calculated sample size was 1400 participants, and a sequential sampling was used. Samples were taken from the vaginal wall for pH measurement, amine test and Gram staining in order to derive the Nugent score, considered the gold standard in this disease. The lab technicians were blinded to the clinical diagnosis and to the office tests. Sensitivity, specificity ad odds ratio OR (+) and OR (-) were measured, and they are presented as proportions with their respective 95% confidence intervals.
Results: The prevalence of bacterial vaginosis was 39.6 %, and the operational characteristics of the tests with their respective 95 % CI were as follows: sensitivity and specificity of the clinical diagnosis were 75 % (71-78) and 54 % (51-57), respectively; sensitivity and specificity of pH ≥ 5 were 99.3 % (98.2-99.8), and 0.57 % (0.2-1.3); amine test sensitivity 99.3 % (98.2-99.8 %) and
specificity 99.8 % (99.2-100 %); clinical diagnosis plus amine test and pH ≥ 5.0, sensitivity 74 % (71-78), specificity 100 % (99-100).
Conclusions: Clinical diagnosis showed a good sensitivity for diagnosing strategy for diagnosing bacterial vaginosis; specificity is improved when clinical findings are combined with amine test and vaginal pH. The amine test was shown to have excellent sensitivity and specificity, and it is useful to improve the diagnosis of bacterial vaginosis.
Author Biographies
Dauris Mejía-Pérez
Edith Ángel-Müller
Andrea E. Rodríguez-Hernández
Ariel I. Ruiz-Parra
Docente. Departamento de Obstetricia y Ginecología, Facultad de Medicina, Universidad Nacional de Colombia, Bogotá (Colombia). Instituto de Investigaciones Clínicas, Facultad de Medicina, Universidad Nacional de Colombia, Bogotá (Colombia).
Jorge E. Tolosa-Ardila
Hernando Gaitán-Duarte
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