Correlative analysis of CINtec P16 and detection of HPV DNA by PCR in cervical abnormalities

Abstract

Background The prognostic value of cervical aberrancies cannot be adequately determined by the Pap smear alone. Detection of HPV DNA by polymerase chain reaction (PCR) improves the diagnostic sensitivity however, it lacks sufficient specificity. Biomarkers that demonstrate the power to identify progressive cervical lesions may enhance the accuracy of Pap smear screening. The objective of this study is to investigate the relationship between P16 expression and HPV DNA in cervical smears, and the diagnostic accuracy of these assays. Methods Following p16INK4A immunocytochemical analysis, we subjected 187 abnormally classified cervical smears to HPV detection by PCR. The correlation between HPV DNA and p16INK4A, stratified by cervical cytology, were examined. Results Both assays produced a high sensitivity for the detection of HPV by p16INK4A 96.4% (95% CI, 86.2-99.4), and GP5+/6+ PCR 98.11% (95% CI, 88.6-99.9) in higher grade squamous intraepithelial lesions (HSILs), respectively. The specificity for P16 expression in conjunction with conventional cytology was significant in LSIL 85.7% (66.4-95.3) and ASC-US 50% (20.1-79.9) while the sensitivity peaked when conventional cytology was supplemented by p16INK4A in LSIL 90.12% (81-95.3) and ASC-US 71.4% (51.1-86) lesions. Conclusion The p16INK4A assay show potential to overcome the present restrictions often encountered during cervical cancer screening