HPV genotyping and p16/Ki-67 test significantly improve detection rate of high-grade cervical squamous intraepithelial lesion

Introduction: Liquid-based cytology allows to apply modern and specific analyses of hrHPV genotyping in p16/Ki-67 test. All of these together could raise accuracy ratio for high-grade squamous intraepithelial lesion above 90%. The purpose of this study was to evaluate the diagnostic accuracy of LBC, hrHPV testing, and p16/Ki-67 testing in diagnosis of high-grade cervical intraepithelial lesions.

Material and methods: The study consisted of 176 women, out of which 50 presented with HSIL (CIN2) SCC (cervical intraepithelial lesion grade 2 squamous cell carcinoma). 126 women with a negative Pap test were pooled into the second group of the study. All patients were resampled for LBC, HPV genotyping, and for the p16/Ki-67 test. The research was carried out between May and December 2017, and second sampling were taken from 1 to 4 months.

Results: We reported a strong correlation between positive Pap test and hrHPV (p < 0.05) that met accuracy close to 90%. We noted correlations between a positive p16/Ki-67 with a positive Pap test: p < 0.001; 66% sensitivity (95% CI: 51.2-78.8%), 87.8% specificity (95% CI: 75.2-95.4%), 76.8% accuracy (95% CI: 67.2-84.7%), and OR 13.9 (95% CI: 4.9-39.2), especially HSIL and HPV16: p < 0.001; sensitivity (95% CI) 64.0, specificity (95% CI) 98.4, accuracy (95% CI) 88.6, OR (95% CI) 109.3.

Conclusions: The results of our study indicate hrHPV genotyping as a good biomarker for the triage of patients with an abnormal cytological report. In our opinion, the hrHPV test reaches the highest level of sensitivity, specificity, and accuracy, and should be considered as crucial diagnostic test in cervical screening.