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

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

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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.

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


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