RESUMO
Introducción: La bacteria Chlamydia trachomatis provoca una de las infecciones de transmisión sexual más frecuente. La Organización Mundial de la Salud reporta aproximadamente 131 millones de casos anuales. Objetivo: Evaluar el desempeño de la prueba rápida CROMATEST (Linear Chemicals. S.L. Barcelona España) en muestras clínicas. Métodos: Se estudiaron 72 muestras: 38 exudados vaginales de adolescentes de los hospitales pediátricos Juan Manuel Márquez y el Cerro; y 34 muestras de orina de voluntarios del Instituto de Medicina Tropical "Pedro Kourí. Se empleó el ensayo CROMATEST y como prueba de referencia la reacción en cadena de la polimerasa en tiempo real comercial. Se calculó sensibilidad, especificidad, valor predictivo positivo y negativo. Resultados: Seis muestras resultaron positivas por el test rápido, cinco por la reacción en cadena de la polimerasa en tiempo real y una por la prueba de referencia. De las 66 muestras negativas, una fue negativa para la reacción en cadena de la polimerasa en tiempo real y positiva en el CROMATEST. El porcentaje de concordancia entre ambas pruebas fue del 95 % y el valor de Kappa 0,8182. Se obtuvo una sensibilidad de 83,33 %, una especificidad del 98,48 % y valores predictivos positivo y negativo de 83,33 % y 98,48 %, respectivamente. Conclusiones: La prueba rápida CROMATEST tuvo un desempeño excelente contra la prueba de referencia; por tanto, se recomienda su utilización para la detección de Chlamydia trachomatis.
Introduction: The bacterium Chlamydia trachomatis causes one of the most common sexually transmitted infections. The World Health Organization reports approximately 131 million cases annually. Objective: To evaluate the performance of the CROMATEST rapid test (Linear Chemicals. S.L. Barcelona Spain) in clinical specimens. Methods: 72 samples were studied: 38 vaginal exudates from adolescents from the Juan Manuel Márquez and El Cerro pediatric hospitals; and 34 urine samples from volunteers from the "Pedro Kourí" Tropical Medicine Institute. The CROMATEST assay was used and the commercial real-time polymerase chain reaction was used as a reference test. Sensitivity, specificity, positive and negative predictive value were calculated. Results: Six samples were positive by the rapid test, five by the real-time polymerase chain reaction and one by the reference test. The negative samples were 66, of which one was negative for the real-time polymerase chain reaction and positive in the CROMATEST. The concordance between both tests was 95 % and the Kappa value 0.8182. A sensitivity of 83.33 %, a specificity of 98.48 % and positive and negative predictive values of 83.33 % and 98.48 %, respectively, were obtained. Conclusions: The CROMATEST rapid test performed excellently against the reference test; therefore, its use is recommended for the detection of Chlamydia trachomatis.
RESUMO
BACKGROUND: In Cuba, little is known regarding the prevalence of Chlamydia trachomatis (CT) infection in adolescents and young people. We study the frequency of CT infection in these populations, and its association with clinical-epidemiological variables. METHODS: A total of 496 individuals aged 12 to 24 were recruited from November 2018 to November 2019. Of them, 302 were patients attending at sexually transmitted infections (STI) services and 194 were young volunteers. CT detections were carried out by real-time PCR and IgG serology. RESULTS: The prevalence of CT using PCR was 9.1% (45/496); 12.3% (37/302) for subjects attending STI service and 4.1% (8/194) for young volunteers, being significantly higher in the first group (OR=3.25; p=.001). CT IgG antibodies was detected in 38.6% (81/210). Individuals from 12 to 17 years old were more likely infected with CT (OR=2.21; p=.010). Infection was associated with the early onset of sexual intercourse, the frequent changing of sexual partners and black ethnicity. CONCLUSIONS: The results suggest that Cuban adolescents and young populations are at highest risk of acquiring CT infection and developing reproductive complications. The data obtained advise the needs of implementation of a routine CT screening strategy, for timely diagnosis, detection and treatment at the earliest ages.
Assuntos
Infecções por Chlamydia , Infecções Sexualmente Transmissíveis , Humanos , Adolescente , Criança , Chlamydia trachomatis/genética , Comportamento Sexual , Infecções por Chlamydia/diagnóstico , Infecções por Chlamydia/epidemiologia , Infecções por Chlamydia/prevenção & controle , Infecções Sexualmente Transmissíveis/diagnóstico , Infecções Sexualmente Transmissíveis/epidemiologia , Prevalência , Imunoglobulina G , Fatores de RiscoRESUMO
RESUMEN Introducción: El empleo de técnicas moleculares para el diagnóstico de virus del papiloma humano de alto riesgo oncogénico (VPH-AR) es crucial para la detección precoz del cáncer cervicouterino. Objetivo: Evaluar el desempeño analítico de dos estuches de PCR-tiempo real, comercializados por el Centro de Inmunoensayo de Cuba, para detectar VPH-AR. Métodos: Se utilizaron dos paneles de ADN de muestras cervicouterinas: uno con 150 muestras, para validar el estuche SUMASIGNAL HPV 16/18, el proceso de extracción de ADN y su utilidad como prueba cuantitativa, y otro con 163 muestras para evaluar el estuche HPV 13+2. Se determinó la utilidad clínica del estuche HPV 13+2 en 55 muestras cervicovaginales autocolectadas. Se calcularon los indicadores de desempeño analítico de ambos estuches con respecto a pruebas de referencia. Resultados: Los indicadores de desempeño para SUMASIGNAL HPV 16/18 fueron excelentes (> 95 %), concordancia 96 %, índice kappa=0,93 [0,85-1,01]. La extracción de ADN mostró 100 % de especificidad clínica y analítica y 95 % de sensibilidad analítica. Se obtuvo buena correlación con la prueba de referencia cuantitativa (r = + 0,688). El estuche HPV 13+2 tuvo especificidad y sensibilidad clínicas del 100 %, la especificidad analítica fue del 84 % debido a reactividad cruzada con otros VPH-AR. Su aplicación clínica reveló alta frecuencia de infección (41,8 %): 23,6 % con VPH-AR, particularmente en mujeres jóvenes (50 %). La muestra autocolectada resultó útil (100 %). Conclusión: Los ensayos evaluados mostraron altos estándares de calidad, lo que permitiría su uso con una cobertura nacional en una plataforma tecnológica disponible para todo el país.
ABSTRACT Introduction: The use of molecular techniques for the diagnosis of high oncogenic risk human papillomavirus (hrHPV) is crucial for the early detection of cervical cancer. Objective: To evaluate the analytical performance of two real-time PCR kits, commercialized by the Cuban Immunoassay Center, to detect hrHPV. Methods: Two DNA panels from cervical samples were used: one with 150 samples to validate the SUMASIGNAL HPV 16/18 kit, the DNA extraction process and its usefulness as a quantitative test; and another with 163 samples to evaluate the HPV 13+2 kit. The clinical utility of the HPV 13+2 kit was determined in 55 self-collected cervicovaginal samples. The analytical performance indicators of both kits were calculated with respect to reference tests. Results: Performance indicators for SUMASIGNAL HPV 16/18 were excellent (>95%), concordance 96%, kappa index=0.93 [0.85-1.01]. DNA extraction showed 100% clinical and analytical specificity and 95% analytical sensitivity. Good correlation was obtained with the quantitative reference test (r = + 0.688). The HPV 13+2 kit had 100% clinical specificity and sensitivity, analytical specificity was 84% due to cross-reactivity with other hrHPVs. Its clinical application revealed a high frequency of infection (41.8%): 23.6% with hrHPV, particularly in young women (50%). The self-collected sample was viable (100%). Conclusion: The assays evaluated showed high quality standards, which would allow their use with national coverage in a technological platform available for the whole country.