Joan Valls, PhD, Armando Baena, PhD, Gino Venegas, MD, Marcela Celis, MD, Mauricio González, MD, Carlos Sosa, MD, Jorge Luis Santin, MD, Marina Ortega, MD, Ana Soilán, MD, Elmer Turcios, MD, Jacqueline Figueroa, MD, Margarita Rodríguez de la Peña, MD, Alicia Figueredo, MD, Andrea Verónica Beracochea, MD, Natalia Pérez, MD, Josefina Martínez-Better, MD, Oscar Lora, MD, Julio Yamil Jiménez, MD, Diana Giménez, MD, Laura Fleider, MD, Yuly Salgado, BSN, Sandra Martínez, BSN, Yenny Bellido-Fuentes, BSN, Bettsy Flores, MD, Silvio Tatti, MD, Verónica Villagra, MD, Aurelio Cruz-Valdez, MD, Carolina Terán, MD, Gloria Inés Sánchez, MD, Guillermo Rodríguez, MD, Maria Alejandra Picconi, PhD, Annabelle Ferrera, MD, Laura Mendoza, ProfPhD, Alejandro Calderón, MD, Raul Murillo, MD, Carolina Wiesner, MD, Nathalie Broutet, MD, Silvana Luciani, MD, Carlos Pérez, MD, Teresa M Darragh, ProfMD, José Jerónimo, MD, Rolando Herrero, MD, and Maribel Almonte, PhD
Summary: Background: Colposcopy, currently included in WHO recommendations as an option to triage human papillomavirus (HPV)-positive women, remains as the reference standard to guide both biopsy for confirmation of cervical precancer and cancer and treatment approaches. We aim to evaluate the performance of colposcopy to detect cervical precancer and cancer for triage in HPV-positive women. Methods: This cross-sectional, multicentric screening study was conducted at 12 centres (including primary and secondary care centres, hospitals, laboratories, and universities) in Latin America (Argentina, Bolivia, Colombia, Costa Rica, Honduras, Mexico, Paraguay, Peru, and Uruguay). Eligible women were aged 30–64 years, sexually active, did not have a history of cervical cancer or treatment for cervical precancer or a hysterectomy, and were not planning to move outside of the study area. Women were screened with HPV DNA testing and cytology. HPV-positive women were referred to colposcopy using a standardised protocol, including biopsy collection of observed lesions, endocervical sampling for transformation zone (TZ) type 3, and treatment as needed. Women with initial normal colposcopy or no high-grade cervical lesions on histology (less than cervical intraepithelial neoplasia [CIN] grade 2) were recalled after 18 months for another HPV test to complete disease ascertainment; HPV-positive women were referred for a second colposcopy with biopsy and treatment as needed. Diagnostic accuracy of colposcopy was assessed by considering a positive test result when the colposcopic impression at the initial colposcopy was positive minor, positive major, or suspected cancer, and was considered negative otherwise. The main study outcome was histologically confirmed CIN3+ (defined as grade 3 or worse) detected at the initial visit or 18-month visit. Findings: Between Dec 12, 2012, and Dec 3, 2021, 42 502 women were recruited, and 5985 (14·1%) tested positive for HPV. 4499 participants with complete disease ascertainment and follow-up were included in the analysis, with a median age of 40·6 years (IQR 34·7–49·9). CIN3+ was detected in 669 (14·9%) of 4499 women at the initial visit or 18-month visit (3530 [78·5%] negative or CIN1, 300 [6·7%] CIN2, 616 [13·7%] CIN3, and 53 [1·2%] cancers). Sensitivity was 91·2% (95% CI 88·9–93·2) for CIN3+, whereas specificity was 50·1% (48·5–51·8) for less than CIN2 and 47·1% (45·5–48·7) for less than CIN3. Sensitivity for CIN3+ significantly decreased in older women (93·5% [95% CI 91·3–95·3] in those aged 30–49 years vs 77·6% [68·6–85·0] in those aged 50–65 years; p