Are adjunctive markers useful in routine cervical cancer screening? Application of p16 INK4a and HPV‐PCR on ThinPrep samples with histological follow‐up

The objectives of the study were to evaluate 1) the diagnostic sensitivity and specificity of p16 INK4a as a marker for high‐grade cervical lesions, 2) the results of a real‐time polymerase chain reaction detecting high‐risk human papillomavirus, and 3) the interobserver variability of the p16 INK4a interpretation. A total of 232 ThinPrep samples were stained for p16 INK4a , and HPV‐DNA PCR was performed on 107 specimens with inclusion of both benign and abnormal cytology. Histological follow‐up information was collected. The diagnostic sensitivity of ASC+ with CIN2+ in histology as endpoint was 96% for p16 INK4a and 100% for HR‐HPV DNA PCR, and the diagnostic specificity was 41% and 27%, respectively. If p16 INK4a had been used for triage of the ASC samples, then 18 patients (42%) could have been spared unnecessary follow‐up procedures compared to six patients (21%) with the HR‐HPV DNA test. Diagn. Cytopathol. 2008;36:453–459. © 2008 Wiley‐Liss, Inc.