P16 Immunohistochemistry Interpretation by Nonpathologists as an Accurate Method for Diagnosing Cervical Precancer and Cancer

Guang Dong Liao, Le Ni Kang, Wen Chen, Xun Zhang, Xiao Yang Liu, Fang Hui Zhao, Mark H. Stoler, Anne Mills, Ming Rong Xi, You Lin Qiao, Philip E. Castle

Research output: Contribution to journalArticle

3 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)207-211
Number of pages5
JournalJournal of Lower Genital Tract Disease
Issue number3
StatePublished - Jul 26 2015



  • Pap
  • VIA
  • cervical intraepithelial neoplasia
  • human papillomavirus
  • immunohistochemistry
  • p16

ASJC Scopus subject areas

  • Obstetrics and Gynecology

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