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

Autor: María Cecilia Agudelo, Edmundo Torres-González, Samuel Agudelo, Arianis Tatiana Ramírez, Kelly Melisa Castañeda, Connor J. Kinslow, María Rodríguez-Herrera, Lisa Garland, Yi Xie, Carlos Alberto Orozco, Mark Stoler, Michael Dean, Gloria Inés Sánchez
Jazyk: English<br />Spanish; Castilian
Rok vydání: 2024
Předmět:
Zdroj: Biomédica: revista del Instituto Nacional de Salud, Vol 44, Iss Sp. 1, Pp 101-109 (2024)
Druh dokumentu: article
ISSN: 0120-4157
2590-7379
DOI: 10.7705/biomedica.7061
Popis: 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
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