Comparison of ProExC and p16ink4a Biological Markers in Lesional Smears With the Immunocytochemical Method and Relationship With Human Papillomavirus in Liquid-based Cervicovaginal Specimens.

Background: This study investigated the determination of human papillomavirus (HPV) types in smears with and without lesions, and the sensitivity, specificity, positive predictive value, and negative predictive value of the ProExC and p16 biomarkers in smears with lesions.

Materials and methods: A total of 192 cervicovaginal smears were included in the study. ProExC (BD) and p16ink4a antibodies were applied to the lesion-containing samples by immunocytochemical method. If HPV was present, its type was determined. Patient biopsy specimens were used as a gold standard to confirm the lesion type. In addition, atypical squamous cells of undetermined significance, low-grade squamous intraepithelial lesion (SIL), atypical squamous cells, cannot exclude high-grade SIL (HSIL), and HSIL, atypical glandular cells, and the relationship between two biomarkers in cases diagnosed with squamous cell carcinoma were investigated.

Results: Of these, 192 cases included in our study, 119 had lesional smears and 73 had no lesional cells. Of the 191 cases in which HPV was investigated, 105 were negative and 86 were positive for HPV types 16, 18, and others. A statistically significant difference was found between HPV positivity and smears with lesions (P = 0.0001). p16 and ProExC positivity was extensive in cases with more severe lesions. A strong correlation was observed between high-risk HPV (+) and HSIL-detected cases.

Conclusion: ProExC and p16 are biomarkers that facilitate the diagnosis of HSIL. Nuclear staining for the ProExC marker is easier to apply to cytological samples than p16.