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Background The HPV detection test is not recommended as a primary screening of cervical lesions, before the age of 30, because the high rate of HPV infections with a high rate of spontaneous resolution in this age group. This study aims to evaluate the performance of p16/Ki67 dual staining in detecting high-grade squamous cervical lesions in these women. Methods Cervical-vaginal samples from 67 women HPV positives under the age of 30 and cervical biopsies of 41 of these women. Results of p16/Ki67 dual staining, cytology and histology were analysed. In 53 of the women, 159 results of p16/Ki67 dual staining, HPV test and cytology, obtained in 3 follow-up medical visit, were compared. Results The p16/ki67 dual staining was positive in 23.9% and negative in 76.1% of all 67 women. All women with high squamous intraepithelial lesion cytology, 39.1% with low squamous intraepithelial lesion cytology, 17.4% with negative for intraepithelial lesion cytology and 10% with atypical squamous cells cytology, were p16/Ki-67 dual staining positives. In the 41 women with histological diagnosis, p16/ki67 dual staining showed a sensitivity of 87.5% and a specificity of 96% to detect HSIL. When comparing, the tests differ significantly (P &amp;lt; 0.001), p16/ki67 dual staining was positive in 24% of positive cytology and in 19.5% of positive HPV tests. Conclusions Our results demonstrate that p16/Ki67 dual stain has good sensitivity and specificity to detect HSIL and can be useful on women under the age of 30, avoiding excessive diagnosis and reducing colposcopy referrals. Further studies are required in a large number of women.

Gynaecological cytology in women under the age of 30—the impact of P16/KI67 dual-staining cytology