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p16 Immunohistochemistry Interpretation by Nonpathologists as an Accurate Method for Diagnosing Cervical Precancer and Cancer

Liao, Guang-Dong MD1,2; Kang, Le-Ni BS2; Chen, Wen PhD2; Zhang, Xun MD3; Liu, Xiao-Yang BS3; Zhao, Fang-Hui MD, PhD2; Stoler, Mark H. MD4; Mills, Anne MD4; Xi, Ming-Rong MD1; Qiao, You-Lin MD, PhD2; Castle, Philip E. MPH, PhD5,6

Journal of Lower Genital Tract Disease:
doi: 10.1097/LGT.0000000000000080
Original Articles - Cervix and HPV
Abstract

Objective: We conducted a pilot study of whether nonpathologists could accurately diagnose cervical precancer in biopsies using only a basic light microscope, evaluating p16INK4a immunohistochemistry (p16 IHC) of biopsies, and video-based training for both.

Materials and Methods: Using biopsies collected as part of a screening study conducted in rural China, we randomly selected 50 biopsies with a precancerous diagnosis of cervical intraepithelial neoplasia grade 2 (CIN2) or more severe (CIN2+) and 50 biopsies with diagnosis of CIN less severe than CIN2, and stained them for p16 using a commercial IHC kit. Twelve nonpathologists of varying educational backgrounds living in Beijing, China received video training and were assigned one of 4 sets of 25 CIN2+ and 25 CIN less severe than CIN2 for evaluation. A pathologist reviewed all 100 cases.

Results: The mean sensitivity and specificity of the p16 IHC staining scored by the nonpathologists were 91.7% and 94.1%, respectively, compared to scoring by the pathologist. The readers and the pathologist agreed on p16 IHC scoring for 42 (84%) of the 50 slides of CIN less severe than CIN2 and 37 (74%) of the 50 CIN2+ slides. The mean sensitivity and specificity for consensus CIN2+ of p16 IHC as scored by the readers were 88% and 87%, respectively, versus an overall sensitivity and specificity by the pathologist of 96% and 92%, respectively.

Conclusions: We demonstrated that nonpathologists can accurately diagnose CIN2+ using p16 IHC alone.

In Brief

Nonpathologists can accurately diagnose CIN2+ using p16 immunohistochemistry alone.

Author Information

1Department of Gynecology and Obstetrics, the West China Second University Hospital, Sichuan University, Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, China; 2Department of Epidemiology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China; 3Department of Pathology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China; 4Department of Pathology, University of Virginia, Charlottesville, VA; 5Global Cancer Initiative, Chestertown, MD; and 6 Global Coalition Against Cervical Cancer, Arlington, VA

Reprint requests to: Philip Castle, MPH, PhD, Global Coalition Against Cervical Cancer, 3800 Fairfax Dr, Arlington, VA 22204. E-mail: castle.philip@gmail.com

The Bill & Melinda Gates Foundation and the NIH Fogarty International Clinical Research Scholars Program (NIH; R24 TW007988) funded this work.

Copyright © 2015 by the American Society for Colposcopy and Cervical Pathology