Comparison of Hybribio-H13 and Hybrid Capture® 2 human papillomavirus tests for detection of CIN2+ and CIN3+

ABSTRACT: Introduction. Low-cost, accurate high-risk HPV tests are needed for cervical cancer screening in limited-resource settings. Objective. To compare the performance of the low-cost Hybribio-H13 test with the Hybrid Capture® 2 to detect cervical intraepithelial neoplasia grade 2 or 3 (CIN2 and CIN3). Materials and methods. Archived baseline samples tested by the Hybrid Capture® 2 from women of the ASCUS-COL trial, aged 20 to 69 years, with biopsy-colposcopy directed diagnosis of CIN2+ (n = 143), CIN3+ (n = 51), and < CIN2 (n = 632) were blindly tested by the Hybribio-H13 test. Results. The relative sensitivity of the Hybribio-H13 test versus the Hybrid Capture® 2 for detecting CIN2+ was 0.89 (90% CI = 0,80-0,98; NIT = 0,66), and for CIN3+ was 0,92 (90% CI = 0,85-0,98; NIT = 0,35). Relative specificity was 1.19 (90% CI = 1.05-1.33; NIT < 0.00001). In the analysis restricted to women older than 30 years, the relative sensitivity of the Hybribio-H13 for CIN3+ was marginally below unity (ratio = 0.97; 90% CI = 0.95-0.99), and the specificity remained higher than the Hybrid Capture® 2 test. Conclusion. The Hybribio-H13 test was as specific as the Hybrid Capture® 2 for detecting CIN2+ or CIN3+ but less sensitive. Considering these results and the young age of the population recruited for screening because of ASCUS cytology, we suggest our results warrant the evaluation of the Hybribio-H13 for screening cervical cancer, especially in the evaluated population.

• Autores: Agudelo Fernández, María Cecilia; Agudelo Gamboa, Samuel; Ramírez Pineda, Arianis Tatiana; Castañeda Vanegas, Kelly Melisa; Orozco Castaño, Carlos Alberto; Sánchez Vásquez, Gloria
• Tipo de recurso: Article of investigation
• Fecha de publicación: 2024
• Institución: Universidad de Antioquia
• Repositorio: Repositorio UdeA
• Idioma: eng
• OAI Identifier: oai:bibliotecadigital.udea.edu.co:10495/45279
• Acceso en línea: https://hdl.handle.net/10495/45279
• Palabra clave: Detección Precoz del Cáncer; Early Detection of Cancer; Virus del Papiloma Humano; Human Papillomavirus Viruses; Papillomaviridae; Infecciones por Papillomavirus; Papillomavirus Infections; Sensibilidad y Especificidad; Sensitivity and Specificity; Displasia del Cuello del Útero; Uterine Cervical Dysplasia; https://id.nlm.nih.gov/mesh/D055088; https://id.nlm.nih.gov/mesh/D000094302; https://id.nlm.nih.gov/mesh/D027383; https://id.nlm.nih.gov/mesh/D030361; https://id.nlm.nih.gov/mesh/D012680; https://id.nlm.nih.gov/mesh/D002578
• Rights: openAccess
• License: http://creativecommons.org/licenses/by/2.5/co/