Self-collection for high-risk HPV detection in Brazilian women using the careHPV™ test Adriana Tarlá Lorenzi a, ⁎, José Humberto T.G. Fregnani b , Júlio César Possati-Resende c , Cristovam Scapulatempo Neto d , Luisa Lina Villa e,f , Adhemar Longatto-Filho b,g,h,i, ⁎ a Molecular Oncology Center, Barretos Cancer Hospital, Barretos, São Paulo, Brazil b Center for the Researcher Support, Barretos Cancer Hospital, Barretos, São Paulo, Brazil c Cancer Prevention Department, Barretos Cancer Hospital, Barretos, São Paulo, Brazil d Pathology Department, Barretos Cancer Hospital, Barretos, São Paulo, Brazil e Santa Casa de São Paulo Medical School, FCMSCSP, São Paulo, Brazil f Faculty of Medicine, Department of Radiology and Basic Oncology, São Paulo University, FMUSP, São Paulo, Brazil g Laboratory of Medical Investigation (LIM)14, Faculty of Medicine, São Paulo University, FMUSP, São Paulo, Brazil h Life and Health Sciences Research Institute, ICVS, School of Health Sciences, Minho University, Braga, Portugal i ICVS/3B's–PT Government Associate Laboratory, Braga/Guimarães, Portugal HIGHLIGHTS • High-risk HPV was tested in careHPV™ methodology. • HPV test self-sampled material is useful for cervical cancer screening. abstract article info Article history: Received 12 June 2013 Accepted 16 July 2013 Available online 21 July 2013 Keywords: Human papillomavirus Cervical cancer Self-sampling Molecular test Screening Objective. Cervical cancer is the second most common cancer among Brazilian women. High-risk human pap- illomavirus (hr-HPV) persistence is the primary cause of cervical neoplasia. Early detection of hr-HPV is important for identifying women at risk for developing cervical lesions. Approximately 85% of new cases of cervical cancer worldwide and 50% of the total cervical cancer deaths occurred in developing countries. Here, a new methodology to support a cervical cancer screening program was evaluated in women from various Brazilian regions. Methods. Two thousand women aged 18–77 years were enrolled in an opportunistic cervical cancer screen- ing program and were randomized into self-vaginal or health professional-guided cervical sampling groups. The Qiagen careHPV™ test was performed on all samples. Pap tests were performed on all women using liquid-based cytology. Results. Positive hr-HPV results were obtained in 12.3% (245/2000) of women; similar rates were observed in self- or health professional-collected samples. Eighty-nine percent (1719/2000) of cervical cytologies classified as normal were negative to hr-HPV. Among the cytological samples, 36.6% classified as ASC-US+ were positive to hr-HPV, 78.8% were LSIL and 75.0% were HSIL. Conclusions. Self-sampled and health professional-sampled vaginal/cervical specimens did not differ in their rates of detection of hr-HPV. Therefore, HPV DNA testing in self-sampled vaginal cells is an alternative to primary screening in low-resource settings. © 2013 Elsevier Inc. All rights reserved. Introduction Cervical cancer (CC) is a well-known disease worldwide and re- mains a critical public health issue in developing countries that lack appropriate screening programs. Consequently, 85% of cases and 50% of deaths due to CC occur in developing countries, particularly in the poorest regions. Most Brazilian regions have dramatic indexes of mortality: CC is the second most common cancer among Brazilian women, with mortality rates estimated to be more than 10,000 deaths annually and more than 17,000 new cases occurring each year [1,2]. Human papillomavirus (HPV) infections are prevalent worldwide. Persistent hr-HPV infection is the single main risk factor for the devel- opment of premalignant and malignant cervical lesions [3]. HPV causes virtually all cases of cervical cancer [4]. Cervical cancer screening Gynecologic Oncology 131 (2013) 131–134 ⁎ Corresponding author at: Laboratory of Medical Investigation (LIM) 15, Faculty of Medicine, São Paulo University, São Paulo 1246-903, Brazil. Fax: +55 11 3061 7413. E-mail addresses: adriana.lorenzi@gmail.com (A.T. Lorenzi), mdfregnani@terra.com.br (J.H.T.G. Fregnani), julio.possati@uol.com.br (J.C. Possati-Resende), cristovamscapula@uol.com.br (C.S. Neto), luisapvilla@gmail.com (L.L. Villa), longatto16@hotmail.com (A. Longatto-Filho). 0090-8258/$ – see front matter © 2013 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.ygyno.2013.07.092 Contents lists available at ScienceDirect Gynecologic Oncology journal homepage: www.elsevier.com/locate/ygyno