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.