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The Sensitivity and Specificity of p16INK4a Cytology vs HPV Testing for Detecting High-Grade Cervical Disease in the Triage of ASC-US and LSIL Pap Cytology Results

Karin J. Denton MD, Christine Bergeron MD, PhD, Petra Klement, Marcus J. Trunk MD, Thomas Keller PhD, Ruediger Ridder PhD on behalf of for the European CINtec Cytology Study Group
DOI: http://dx.doi.org/10.1309/AJCP3CD9YKYFJDQL 12-21 First published online: 1 July 2010


We analyzed the performance of p16INK4a immunocytochemistry on a series of 810 retrospectively collected atypical squamous cells of undetermined significance (ASC-US) and low-grade squamous intraepithelial lesion (LSIL) cases with available biopsy follow-up data, including 94 cases of cervical intraepithelial neoplasia (CIN) 2 and 128 cases of CIN 3. Human papillomavirus (HPV) testing was performed from the same residual liquid-based cytologic specimen, and results for both tests were correlated with histologic follow-up data. Sensitivity values for high-grade CIN (HGCIN) confirmed on biopsy within 6 months were 92.6% (ASC-US) and 92.2% (LSIL) for cytotechnologists’ reviews of p16 cytology and 90.1% (ASC-US) and 95.7% (LSIL) for HPV testing. Sensitivity rates of initial pathologists’ reviews were slightly lower, 76.4% to 80.1%, with levels comparable to cytotechnologists’ results after adjudication. The specificity of p16 cytology for HGCIN detection was significantly higher than for HPV testing for cytotechnologists and pathologists: 63.2% to 71.1% (p16 cytology) vs 37.8% for HPV in ASC-US (P < .001) and 37.3% to 53.3% (p16 cytology) vs 18.5% for HPV in LSIL (P < .001). This evaluation of the diagnostic performance of p16 cytology confirms the potential of this stain for the efficient triage of ASC-US and LSIL cytologic results.

Key Words:
  • Cervical intraepithelial neoplasia
  • Cervical cytology
  • Atypical squamous cells of undetermined significance
  • ASC-US
  • Low-grade squamous intraepithelial lesion
  • LSIL
  • Triage
  • p16INK4a
  • Immunocytochemistry
  • Human papillomavirus
  • HPV
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