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Comparison of HPV-based assays with Papanicolaou smears for cervical cancer screening in Morelos State,Mexico
Authors:Salmerón Jorge  Lazcano-Ponce Eduardo  Lorincz Attila  Hernández Mauricio  Hernández Pilar  Leyva Ahideé  Uribe Mario  Manzanares Horacio  Antunez Alfredo  Carmona Enrique  Ronnett Brigitte M  Sherman Mark E  Bishai David  Ferris Daron  Flores Yvonne  Yunes Elsa  Shah Keerti V
Affiliation:(1) Unidad de Investigación Epidemiológica y en Servicios de Salud, Instituto Mexicano del Seguro Social, Av. Plan de Ayala Esq. Av. Central S/N, Cuernavaca, Morelos, C.P. 62450, México;(2) Centro de Investigación en Salud Poblacional, Instituto Nacional de Salud Pública, Morelos, México;(3) Digene Corporation, Gaithersburg, MD, USA;(4) Departamento de Ginecología, Hospital Regional de Cuernavaca, Instituto Mexicano del Seguro Social, Morelos, México;(5) Departamento de Patología, Hospital Regional de Cuernavaca, Instituto Mexicano del Seguro Social, Morelos, México;(6) Department of Pathology, The Johns Hopkins Medical Institutions, Baltimore, MD, USA;(7) Department of Population and Family Health Sciences, Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA;(8) Medical College of Georgia, Augusta, Georgia, USA;(9) Unidad de Investigación Epidemiológica y en Servicios de Salud, Instituto Mexicano del Seguro Social, Morelos, México;(10) Department of Molecular Microbiology and Immunology, Johns Hopkins University, Bloomberg School of Public Health, Baltimore, MD, USA
Abstract:Objective: To compare the performance of human papillomavirus (HPV) assays with conventional Pap cytology for cervical cancer (CC) screening in Mexico. Methods: Pap smears, self-collected vaginal specimens (SS) for HPV testing, and clinician-collected cervical specimens (CS) for HPV testing were obtained from 7868 women, aged 15–85 years old, attending CC screening at the Mexican Institute of Social Security (IMSS) between May and October, 1999. SS and CS specimens were screened for oncogenic HPV DNA by Hybrid Capture 2. Women who received cytological interpretations of atypical squamous cells of undetermined significance (ASCUS), and/or a positive HPV test were referred for colposcopy and histologic studies. The relative estimates for sensitivity, specificity and predictive values of each test were calculated using histological diagnoses of cervical intraepithelial neoplasia (CIN) grades 2 or 3, or CC histological diagnosis. Results: Oncogenic HPV detection rate was 11.6% for SS, and 9.3% for CS. Pap smear abnormalities were observed in 2.4% of the women. Of 1147 women who had at least one abnormal test result, 88.5% underwent colposcopy, and 101 biopsy-confirmed CIN2/3 or cancer cases were identified. The relative sensitivity estimates for the Pap test, SS and CS were 59.4% (95% CI: 49.2–68.9), 71.3% (95% CI: 61.3–79.6), and 93.1% (95% CI: 85.8–96.9), respectively, while the specificities were 98.3% (95% CI: 98.0–98.6), 89.2% (95% CI: 88.5–89.9), and 91.8% (95% CI: 91.2–92.4), respectively. The positive predictive values of Pap, SS and CS were 36.1, 9.1 and 14.9, the colposcopy referrals needed to detect a case of CIN2/3 or cancer were 2.8, 11.0 and 6.7, respectively. Discussion: Both HPV assays detected more cases of CIN2/3 or CC than Pap cytology alone. However, the HPV assays increased the number of colposcopy referrals. Our study suggests that HPV testing could be an effective way to improve the performance of CC screening.
Keywords:cervical cancer  HPV assays  Mexico  pap smears
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