Department of Epidemiology, Faculty of Medicine, George Emil Palade University of Medicine, Pharmacy, Science, and Technology of Târgu Mureş, Romania;
Rom J Morphol Embryol. 2024 Jan-Mar;65(1):99-105. doi: 10.47162/RJME.65.1.12.
Immunohistochemistry (IHC) for p16INK4A (p16) is a reliable surrogate test for the presence of a high-risk, potentially transformative human papillomavirus (HPV) infection in precursor and malignant lesions of the cervix. The purpose of this study was to evaluate changes in cervical cells caused by persistent HPV infection, by IHC (p16 protein) by comparison with HPV genotyping.
PATIENTS, MATERIALS AND METHODS: The study included female patients aged between 26 and 57 years who presented to a public hospital, with complaints related to the genital area, namely vaginal bleeding and dyspareunia. After selecting the patients, samples were subjected to cytological testing and IHC for p16 and for the determination of HPV types.
The relationship between HPV status and p16 status was statistically significant (p=0.0001), of the 41 patients, 53.7% were HPV positive, respectively 56.1% were p16 positive, the agreement relationship between the two indicators was very high (weighted kappa: 0.951). The clinical performance of CINtec® PLUS triage for p16 shows a high positive predictive value (PPV) and a high negative predictive value (NPV) of 95.7% and 100%, respectively, as regards HPV.
The p16 marker (CINtec® PLUS) can be used as a prognostic biomarker and provides clinical usefulness through increased sensitivity (Se) and specificity (Sp) in the triage of women at risk of developing precancerous lesions, compared to cytology that is based on morphology, but has a rather low Se and high Sp, while HPV testing is very sensitive but slightly more specific.
免疫组织化学（IHC）检测 p16INK4A（p16）是一种可靠的替代检测方法，可用于检测宫颈前体和恶性病变中高危、潜在转化型人乳头瘤病毒（HPV）感染的存在。本研究旨在通过 IHC（p16 蛋白）与 HPV 基因分型比较，评估持续 HPV 感染引起的宫颈细胞变化。
患者、材料和方法：本研究纳入了年龄在 26 至 57 岁之间的女性患者，她们因生殖器区域的症状（即阴道出血和性交困难）就诊于一家公立医院。选择患者后，对样本进行细胞学检测和 p16 的 IHC 检测以及 HPV 型别的测定。
HPV 状态与 p16 状态之间存在统计学显著相关性（p=0.0001），在 41 名患者中，53.7%为 HPV 阳性，分别为 56.1%为 p16 阳性，两个指标之间的一致性关系非常高（加权 kappa：0.951）。CINtec® PLUS 筛查 p16 的临床性能显示出高阳性预测值（PPV）和高阴性预测值（NPV），分别为 95.7%和 100%，与 HPV 相关。
p16 标志物（CINtec® PLUS）可作为预后生物标志物，通过增加对有发展为癌前病变风险的女性的敏感性（Se）和特异性（Sp）进行分流，比基于形态学的细胞学具有更高的临床实用性，但 Se 较低而 Sp 较高，而 HPV 检测非常敏感但略更特异。
