331 Comparative Effectiveness of High-Risk HPV (HrHPV) Testing and Liquid-Based Pap Cytology in Detecting Cervical High-Grade Intraepithelial Neoplasia and Malignant Lesions: A Five-Year Retrospective Study at a Single Teaching Institution
Recommended Citation
Rizk A, Chitale D, Yuan L, Baldwin A, Gagnon L, Zhang Z. 331 Comparative Effectiveness of High-Risk HPV (HrHPV) Testing and Liquid-Based Pap Cytology in Detecting Cervical High-Grade Intraepithelial Neoplasia and Malignant Lesions: A Five-Year Retrospective Study at a Single Teaching Institution. Lab Invest 2026; 106(3).
Document Type
Conference Proceeding
Publication Date
3-23-2026
Publication Title
Lab Invest
Keywords
adenocarcinoma in situ, adult, aged, cancer screening, cohort analysis, colposcopy, comparative effectiveness, conference abstract, controlled study, cytology, diagnosis, diagnostic test accuracy study, endocervix, female, histology, human, Human papillomavirus type 16, Human papillomavirus type 18, human tissue, intraepithelial neoplasia, major clinical study, middle aged, Papanicolaou test, retrospective study, squamous cell carcinoma, uterine cervix cancer
Abstract
Disclosures: Ali Rizk: None; Dhananjay Chitale: None; Lisi Yuan: None; Adam Baldwin: None; Lauren Gagnon: None; Ziying Zhang: None Background: The 2019 American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines recommend primary HrHPV testing every five years as the preferred cervical cancer screening strategy for women aged 25–65. Although many institutions have initiated pilot programs or selective implementation, widespread adoption remains limited by infrastructural and logistical barriers. This study evaluates the sensitivity of HrHPV testing in detecting high-grade squamous intraepithelial lesion (HSIL) and malignant cervical lesions, and compares its performance with liquid-based Pap cytology. Design: We performed a retrospective cohort study of histologically confirmed high grade squamous intraepithelial lesion (HSIL), adenocarcinoma in situ (AIS), invasive endocervical adenocarcinoma (EC), and invasive squamous cell carcinoma (SCC) diagnosed between July 2020 and July 2025. Corresponding HrHPV and Pap results preceding tissue diagnosis were collected. Pap results were classified using the 2014 Bethesda System. HrHPV testing was performed with FDA-approved PCR assays targeting HPV16, HPV18, and other high-risk types. Sensitivity was calculated using histologic diagnosis as the reference standard. Results: A total of 429 cases were identified (ages 15–76 years): 357 HSIL, 26 AIS, 8 EC, and 38 SCCs. HrHPV results were available for 387 cases, of which 370 (95.6%) tested positive (HPV16: 109; HPV18: 24; other HrHPV: 176; combined infections: 61). Pap cytology demonstrated broader variability: 75 (17.5%) negative, 106 (24.7%) ASC-US, 80 (18.6%) ASC-H, 44 (10.3%) LSIL, 13 (3.0%) AGC, 93 (21.7%) HSIL, 3 (0.7%) AIS, and 15 (3.5%) positive for malignancy. Using ASC-US or higher as the threshold for test positivity, Pap cytology achieved a sensitivity of 82.5% (354/429) versus 95.6% (370/387) for HrHPV testing. Combined HrHPV and Pap testing achieved 100% sensitivity. [Formula presented] Conclusions: Pap cytology with HrHPV co-testing offers the highest screening performance for detecting HSIL and malignant cervical lesions, achieving 100% sensitivity, but it requires greater resources and incurs higher costs. Primary HrHPV testing is considered the more effective and efficient stand-alone screening method, as it demonstrated superior detection compared with liquid-based Pap cytology (95.6% vs. 82.5%). A negative HrHPV result is more reassuring than a negative Pap test, while cytology shows broader variability across diagnostic categories.
Volume
106
Issue
3
