An Evaluation of Novel, Lower-Cost Molecular Screening Tests for Human Papillomavirus in Rural China

Abstract

New, lower-cost tests that target high-risk human papillomavirus (HR-HPV) have been developed for cervical cancer screening in lower-resource settings but large, population-based screening studies are lacking. Women ages 25 to 65 years and living in rural China (n ¼ 7,543) self-collected a cervicovaginal specimen, had 2 cervical specimens collected by a clinician, and underwent visual inspection after acetic acid (VIA). The self-and one clinician-collected specimens underwent HR-HPV DNA testing by careHPV (QIAGEN) and Hybrid Capture 2 (HC2; QIAGEN) and the other clinician-collected specimen was tested for HPV16, 18, and 45 E6 using OncoE6 (Arbor Vita Corporation). Women who screened positive for any test and a random sample of those negative on all tests underwent colposcopic evaluation. The percent test positive was 1.8% for HPV E6 oncoprotein, between 14% and 18% for HR-HPV DNA testing, and 7.3% for VIA. The sensitivity for cervical intraepithelial neoplasia grade 3 or more severe (CIN3 þ ; n ¼ 99) was 53.5% for OncoE6, 97.0% for both careHPV and HC2 testing of the clinician-collected specimen, 83.8% for careHPV testing and 90.9% for HC2 testing of the self-collected specimen, and 50.5% for VIA. OncoE6 had the greatest positive predictive value (PPV), at 40.8% for CIN3 þ , compared with the other tests, which had a PPV of less than 10%. OncoE6 tested 70.3% positive for HPV16, 18, or 45-positive CIN3 þ and tested negative for all HPV16-, 18-, or 45-negative CIN3 þ (P < 0.0001). HPV E6 oncoprotein detection is useful for identifying women who have cervical precancer and cancer. Cancer Prev Res; 6(9); 938-48. Ó2013 AACR.

Can the careHPV test performed in mobile units replace cytology for screening in rural and remote areas?

“…21,22,35 The findings of the current study endorse this premise because the careHPV test recognized high-grade intraepithelial lesions (CIN31). The performance indices confirm the hypothesis, with remarkably high sensitivity and negative predictive values obtained for the results of the HPV test, either alone or in association with cytology and visual inspection.…”

“…19,[21][22][23][24] Populations in many Brazilian regions have difficulty accessing public health assistance because many individuals reside in areas that are a distance from medical care facilities, roads (when they exist) are extremely bad, and public transportation is lacking. These conditions represent some of the principle motivations for the Barretos Cancer Hospital (BCH) to introduce the use of mobile units (MUs) in 1994 to attend to populations living in remote rural areas, including the midwest, southwest, and northern (Amazon) regions of Brazil; women in these regions comprise a significant percentage of the Brazilian population with HPV-induced lesions.…”

Triage strategies in cervical cancer detection in Mexico: methods of the FRIDA Study

“…Elizabeth Barrios, MSc, (1) Patti Gravitt, PhD, (8) Anna Barbara Moscicki, MD, (9) Kathleen M Schmeler, MD, (10) Yvonne N Flores, PhD, (5,11) Pablo Méndez-Hernández, DSc, (11,12,13) Jorge Salmerón, DSc, (1,5) Torres-Ibarra L y col.…”

Effectiveness of novel, lower cost molecular human papillomavirus‐based tests for cervical cancer screening in rural china

“…15 The institutional review boards of PATH, Cancer Institute and Hospital, Chinese Academy of Medical Sciences (CICAMS) and US National Cancer Institute approved the study.…”