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Cytology-based screening has limited sensitivity to detect cervical precancerous lesion. Hihg risk human papilloma virus (HR HPV) DNA tests increase the detection of CIN II+ lesions, however it cannot differentiate if the infection is or transient or persistent. Its use is often limited by the need of standardisation of laboratory technics and relatively high costs. Recently, several studies analysed the diagnostic performance of p16/Ki67 dual-stained cytology as the possible alternative or coexisting option to HR HPV testing. In most of them the smear is obtained for liquid-based cytology. This study was designed to analyze the usefulness of p16/Ki67 dual immunostaining in conventional cytology, which is the method of choice in cervical cancer screening in our country. 68 women with positive Pap test results were selected. Colposcopy, cervical biopsy and HR HPV DNA tests were performed in all patients. Separate slides for p16/Ki67 were collected at the time of colposcopy. Statistical analysis was performed to establish sensitivity, specificity, positive predictive value, negative predictive value and accurancy for all used tests. Biopsy-confirmed CIN was used as a gold standard for study purposes. The diagnostic accurancy of p16/Ki67 dual-staining was the highest among used tests. Sensitivity of this test to detect CINII+ lesion was comparable to and specificity was higher than for HR HPV test. Similar results were observed for cytologic categories: LSIL and ASCUS. These results suggest that p16/Ki67 immunostaining performed on conventional smears may become alternative or additional to HPV tests, due to its low costs and relatively simple procedure.

P16/Ki67 Dual Immunostaining in Conventional Cytology in Women with Positive Papanicolau Test