Chlamydia trachomatis infection in Cuban adolescent and young populations.

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.

Evaluación de estuches de PCR-tiempo real para detección de virus del papiloma humano de alto riesgo / Evaluation of real-time PCR kits to detect high-risk human papillomavirus

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.