title: The sensitivity and specificity of p16(INK4a) cytology vs HPV testing for detecting high-grade cervical disease in the triage of ASC-US and LSIL pap cytology results.
abstract: We analyzed the performance of p16(INK4a) 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.
authors.affiliation: North Bristol NHS Trust, Bristol, England.
authors.forename: Karin J
authors.initials: KJ
authors.lastname: Denton
authors.forename: Christine
authors.initials: C
authors.lastname: Bergeron
authors.forename: Petra
authors.initials: P
authors.lastname: Klement
authors.forename: Marcus J
authors.initials: MJ
authors.lastname: Trunk
authors.forename: Thomas
authors.initials: T
authors.lastname: Keller
authors.forename: Ruediger
authors.initials: R
authors.lastname: Ridder
mesh_terms: D014408:Biomarkers, Tumor / Q000378:metabolism; D016022:Case-Control Studies; D019941:Cyclin-Dependent Kinase Inhibitor p16 / Q000378:metabolism*; D005188:False Negative Reactions; D005260:Female; D006801:Humans; D007150:Immunohistochemistry; D009363:Neoplasm Proteins / Q000378:metabolism*; D027383:Papillomaviridae / Q000302:isolation & purification; D030361:Papillomavirus Infections / Q000378:metabolism* / Q000821:virology; D012189:Retrospective Studies; D014218:Triage; D002583:Uterine Cervical Neoplasms / Q000378:metabolism* / Q000821:virology*; D002578:Uterine Cervical Dysplasia / Q000378:metabolism* / Q000821:virology*
chemical_list: D014408:Biomarkers, Tumor; C000614131:CDKN2A protein, human; D019941:Cyclin-Dependent Kinase Inhibitor p16; D009363:Neoplasm Proteins