Application of P16INK4a immunocytochemical staining combined with detection of molecular biomarkers of miRNA and CIN1-3 in cervical cancer screening in low-resource settings

SHU Zengyi; MEI Xian; CHEN Jingjing

doi:10.3969/j.issn.1007-8096.2025.07.017

Abstract：Objective To investigate the application of P16INK4a immunohistochemical staining combined with low-cost molecular biomarkers,including miRNA and CIN1-3,in cervical cancer screening in low-resource settings,and evaluate its role in improving screening sensitivity,reducing false negative rates,and enhancing the feasibility of primary healthcare screening.Methods This study enrolled 286 women aged 25-60 years from Shifang People's Hospital,who participated between January 2024 and December 2024.All participants underwent P16INK4a immunocytochemical staining and low-cost molecular biomarkers detection,including miRNA and CIN1-3.Individuals with abnormal screening results will undergo further HPV testing and thinprep cytologic test(TCT).The study assessed the clinical value by comparing the sensitivity,specificity,and screening accuracy of single testing and combined testing.Results Among the 286 participants,the combined detection of P16INK4a immunostaining and low-cost molecular biomarker had a sensitivity of 95.3%and a specificity of 89.4%.Compared to P16INK4a immunostaining alone(with a sensitivity of 80.1%and a specificity of 90.3%)and low-cost molecular biomarker detection alone(with a sensitivity of 83.5%and a specificity of 85.6%),the combined detection significantly improved the sensitivity and reduced the false negative rate.The combined detection also showed a high accuracy in screening for cervical intraepithelial lesions(CIN2+)and cervical cancer,with a higher area under the curve(AUC).Conclusion The combined detection of P16INK4a immunocytochemical staining and molecular biomarkers of miRNA and CIN1-3 offers a more cost-effective alternative compared to HPV testing or TCT cytology.This approach significantly enhances the sensitivity of cervical cancer screening while maintaining high accuracy,making it suitable for primary screening in resource-limited settings.The integrated detection strategy not only improves screening efficiency but also features simplicity and low cost,demonstrating potential for broader clinical application.