Interobserver reproducibility and accuracy of p16/Ki‐67 dual‐stain cytology in cervical cancer screening. Issue 12 (12th August 2014)

• Record Type: Journal Article
• Authors: Wentzensen, Nicolas; Fetterman, Barbara; Tokugawa, Diane; Schiffman, Mark; Castle, Philip E.; Wood, Shannon N.; Stiemerling, Eric; Poitras, Nancy; Lorey, Thomas; Kinney, Walter
• Is Part Of: Cancer cytopathology. Volume 122:Issue 12(2014:Dec.)
• Page Start: 914
• Page End: 920
• Publication Date: 2014-08-12
• Subjects: Cancer -- Cytopathology -- Periodicals; Pathology, Cellular -- Periodicals; Cytology -- Technique -- Periodicals; 611.01815
• DOI: 10.1002/cncy.21473
• Languages: English
• ISSNs: 1934-662X

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="cncy21473-sec-0001" sec-type="section"> <title>BACKGROUND</title> <p>Dual‐stain cytology for p16 and Ki‐67 has been proposed as a biomarker in cervical cancer screening. The authors evaluated the reproducibility and accuracy of dual‐stain cytology among 10 newly trained evaluators.</p> </sec> <sec id="cncy21473-sec-0002" sec-type="section"> <title>METHODS</title> <p>In total, 480 p16/Ki‐67–stained slides from human papillomavirus‐positive women were evaluated in masked fashion by 10 evaluators. None of the evaluators had previous experience with p16 or p16/Ki‐67 cytology. All participants underwent p16/Ki‐67 training and subsequent proficiency testing. Reproducibility of dual‐stain cytology was measured using the percentage agreement, individual and aggregate κ values, as well as McNemar statistics. Clinical performance for the detection of cervical intraepithelial neoplasia grade 2 or greater (CIN2+) was evaluated for each individual evaluator and for all evaluators combined compared with the reference evaluation by a cytotechnologist who had extensive experience with dual‐stain cytology.</p> </sec> <sec id="cncy21473-sec-0003" sec-type="section"> <title>RESULTS</title> <p>The percentage agreement of individual evaluators with the reference evaluation ranged from 83% to 91%, and the κ values ranged from 0.65 to 0.81. The combined κ value was 0.71 for all evaluators and 0.73 for cytotechnologists. The average sensitivity and specificity for the detection of CIN2+ among novice evaluators was 82% and 64%, respectively; whereas the reference evaluation had 84% sensitivity and 63% specificity, respectively. Agreement on dual‐stain positivity increased with greater numbers of p16/Ki‐67–positive cells on the slides.</p> </sec> <sec id="cncy21473-sec-0004" sec-type="section"> <title>CONCLUSIONS</title> <p>Good to excellent reproducibility of p16/Ki‐67 dual‐stain cytology was observed with almost identical clinical performance of novice evaluators compared with reference evaluations. The current findings suggest that p16/Ki‐67 dual‐stain evaluation can be implemented in routine cytology practice with limited training. <bold><italic>Cancer (Cancer Cytopathol)</italic> 2014;122:914–920.</bold> © <italic>2014 American Cancer Society</italic>.</p> </sec> </abstract>