title: Specimen self-collection and HPV DNA screening in a pilot study of 100,242 women.
abstract: Since cervical cancer remains common in Mexico despite an established cytology screening program, the Ministry of Health recently introduced pilot front-line HPV testing into the Mexican cervical cancer screening program (CCSP). Here, we present the key field performance metrics of this population-based study. High-risk HPV DNA (hrHPV) testing was conducted on self-collected vaginal specimens from 100,242 women aged 25-75 years residing in Morelos State. All hrHPV positive women and a random sample of 3.2% (n = 2,864) of hrHPV negative participants were referred for colposcopic examination. The main disease endpoint of interest was cervical intraepithelial neoplasia grade 2 or higher (CIN2+). We calculated relative risk, positive predictive value and negative predictive value adjusted for screening test verification bias. The overall prevalence of hrHPV was 10.8% (95% CI 10.6-11.0). Women positive for hrHPV had a relative risk of 15.7 for histologically detectable CIN2+. The adjusted positive predictive value of the hrHPV test was 2.4% (95% CI 2.1-2.7); whereas the adjusted negative predictive value was 99.8% (95% CI 99.8-99.9). These findings suggest that large-scale vaginal hrHPV testing in a middle-income country can identify women at greater risk of advanced cervical abnormalities in a programmatically meaningful way but care is warranted to ensure that disease not detectable at colposcopy is kept to a minimum. PASS shows areas that need improvement and sets the stage for wider use of hrHPV screening of self-collected vaginal specimens in Mexico.
authors.affiliation: Centro de Investigacion en Salud Poblacional, Instituto Nacional de Salud Pública de México. Cuernavaca Morelos, México.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Lazcano-Ponce
authors.forename: Attila T
authors.initials: AT
authors.lastname: Lőrincz
authors.forename: Leticia
authors.initials: L
authors.lastname: Torres
authors.forename: Jorge
authors.initials: J
authors.lastname: Salmerón
authors.forename: Aurelio
authors.initials: A
authors.lastname: Cruz
authors.forename: Rosalba
authors.initials: R
authors.lastname: Rojas
authors.forename: Pilar
authors.initials: P
authors.lastname: Hernández
authors.forename: Mauricio
authors.initials: M
authors.lastname: Hernández
mesh_terms: D000328:Adult; D000368:Aged; D055088:Early Detection of Cancer; D005260:Female; D061809:Human Papillomavirus DNA Tests; D006801:Humans; D008800:Mexico; D008875:Middle Aged; D060787:Neoplasm Grading; D013048:Specimen Handling; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000453:epidemiology* / Q000821:virology
keywords: Mexico; cervical cancer; high-risk HPV testing; vaginal self-collected samples