This study examined the efficacy of the OncoE6 TM Cervical Test, careHPV TM and visual inspection with acetic acid (VIA) in identifying women at risk for cervical cancer and their capability to detect incident cervical precancer and cancer at 1-year follow-up. In a population of 7,543 women living in rural China, women provided a self-collected and two clinician-collected specimens and underwent VIA. All screen positive women for any of the tests, a~10% random sample of test-negative women that underwent colposcopy at baseline, and an additional~10% random sample of test-negative women who did not undergo colposcopy at baseline (n 5 3,290) were recruited. 2,904 women were rescreened 1 year later using the same tests, colposcopic referral criteria, and procedures. Sensitivities of baseline tests to detect 1-year cumulative cervical intraepithelial neoplasia Grade 3 or cancer (CIN31) were 96.5% and 81.6% for careHPV TM on clinician-collected and selfcollected specimens, respectively, and 54.4% for OncoE6 TM test. The OncoE6 TM test was very specific (99.1%) and had the greatest positive predictive value (PPV; 47.7%) for CIN31. Baseline and 1-year follow-up cervical specimens testing HPV DNA positive was sensitive (88.0%) but poorly predictive (5.5-6.0%) of incident CIN21, whereas testing repeat HPV16, 18 and 45 E6 positive identified only 24.0% of incident CIN21 but had a predictive value of 33.3%. This study highlights the different utility of HPV DNA and E6 tests, the former as a screening and the latter as a diagnostic test, for detection of cervical precancer and cancer.Well organized, comprehensive cytology-based screening programs have reduced the incidence of cervical cancer by 70% or more. 1 More than 80% of the 530,000 annual cervical cancer cases and 270,000 annual cervical cancer-related deaths occur in women living in low-and middle-income countries (LMICs) 2,3 due to their inability to establish or maintain a high-quality, high-coverage cytology-based screening programs. 1,4,5 As a consequence, and due to the common exposure to human papillomavirus (HPV) infection worldwide, cervical cancer remains a leading cause of cancer-related deaths and years of life lost in women living in developing countries, a situation markedly different from the developed world. 1,6 New cervical cancer screening strategies have emerged including visual inspection after acetic acid (VIA) and molecular testing for high-risk human papillomavirus (hrHPV). Recent World Health Organization guidelines recommend hrHPV testing, if it can be afforded, or VIA instead of cytology for those countries that are unable to establish a highcoverage, effective cytology testing-based screening program.
7In randomized clinical trials, testing for hrHPV DNA has shown to be more effective than cytology in reducing cervical cancer incidence in about 5 years 8 and more effective than cytology and VIA in reducing cervical cancer-related deaths in 8 years.9 Importantly, hrHPV DNA testing is highly