RESUMO
INTRODUCTION: A prospective study was designed to assess the performance of the new CT OligoGen kit and the cobas 4800 assay for detection of Chlamydia trachomatis. METHODS: A set of samples that included urine samples (n = 212), endocervical (n = 167), rectal (n = 53), pharyngeal (n = 7) and urethral swabs (n = 3). The samples were sent from a regional sexually transmitted diseases (STD) clinic in Seville, Spain, and were collected from 261 men and 181 women. Discordant results were re-analyzed and clinical data and other tests were reviewed in order to resolve them. RESULTS: Sensitivity, specificity, positive predicative value (PPV), negative predictive value (NPV) and kappa value for C. trachomatis detection using the CT OligoGen kit were 98.5%, 100%, 100%, 95.4% and 0.97, respectively. Conclusions This new kit had a high sensitivity, specificity, PPV and NPV for C. trachomatis, therefore the performance profile confirms the usefulness and reliable results of this new assay
INTRODUCCIÓN: Se diseñó un estudio prospectivo para evaluar las características del nuevo kit CT OligoGen en comparación con el test cobas 4800 para la detección de Chlamydia trachomatis. MÉTODOS: Se analizaron una serie de muestras que incluían orinas (n = 212), exudados endocervicales (n = 167), rectales (n = 53), faríngeos (n = 7) y uretrales (n = 3). Estas muestras provenían de un centro de infecciones de transmisión sexual (Sevilla) y pertenecían a 261 hombres y 181 mujeres. Los resultados discordantes se reanalizaron y revisaron historias clínicas y otras pruebas para resolverlas. RESULTADOS: Los valores de sensibilidad, especificidad, valor predictivo positivo (VPP) y negativo (VPN) y valor kappa para el kit CT OligoGen fue 98,5%, 100%, 100%, 95,4% and 0,97, respectivamente. CONCLUSIONES: Este nuevo kit tuvo una alta sensibilidad, especificidad, VPP y VPN para la detección de C. trachomatis, por lo que esta evaluación confirma su utilidad y fiabilidad
Assuntos
Humanos , Infecções por Chlamydia/diagnóstico , Chlamydia trachomatis/patogenicidade , Patologia Molecular/métodos , Doenças Bacterianas Sexualmente Transmissíveis/diagnóstico , Estudos Prospectivos , Reprodutibilidade dos Testes , Reprodutibilidade dos TestesRESUMO
INTRODUCTION: A prospective study was designed to assess the performance of the new CT OligoGen kit and the cobas 4800 assay for detection of Chlamydia trachomatis. METHODS: A set of samples that included urine samples (n=212), endocervical (n=167), rectal (n=53), pharyngeal (n=7) and urethral swabs (n=3). The samples were sent from a regional sexually transmitted diseases (STD) clinic in Seville, Spain, and were collected from 261 men and 181 women. Discordant results were re-analyzed and clinical data and other tests were reviewed in order to resolve them. RESULTS: Sensitivity, specificity, positive predicative value (PPV), negative predictive value (NPV) and kappa value for C. trachomatis detection using the CT OligoGen kit were 98.5%, 100%, 100%, 95.4% and 0.97, respectively. CONCLUSIONS: This new kit had a high sensitivity, specificity, PPV and NPV for C. trachomatis, therefore the performance profile confirms the usefulness and reliable results of this new assay.
