Department of Obstetrics and Gynecology, University of Medicine and Pharmacy "Victor Babeş" Timişoara, Timișoara, Romania.
Bosn J Basic Med Sci. 2019 Nov 8;19(4):336-341. doi: 10.17305/bjbms.2018.3560.
Due to a high rate of transient human papillomavirus (HPV) infection, HPV genotyping has a low specificity for high-grade cervical lesions, especially in young women. p16/Ki-67 dual immunocytochemical staining can also be used for the detection of oncogenic changes in cervical cells. Our aim was to compare the performance of p16/Ki-67 dual staining and HPV genotyping in the detection of high-grade cervical lesions in patients with atypical squamous cells of undetermined significance (ASCUS)/low-grade squamous intraepithelial lesion (LSIL) on Pap smear. We retrospectively analyzed 310 patients with ASCUS/LSIL on Pap smear, who underwent colposcopy. Among these, 161 patients with suspected lesions detected by colposcopy were referred for biopsy. HPV genotyping by LINEAR ARRAY HPV Genotyping Test (CE-IVD) and p16/Ki-67 dual staining by CINtec PLUS Cytology kit was performed prior to cervical biopsy. The overall sensitivity and specificity of HPV genotyping for the detection of cervical intraepithelial neoplasia (CIN) 2-3 was 79% and 72%, respectively in patients with ASCUS, and 85% and 64%, respectively in patients with LSIL. For p16/Ki-67 test, sensitivity and specificity rate was 66% and 93%, respectively in ASCUS and 59% and 79%, respectively in LSIL group. The specificity of p16/Ki-67 staining was significantly higher in both groups in patients aged <30 years compared to patients >30 years old (p < 0.001). Our results showed that p16/Ki-67 dual staining has a higher specificity compared to HPV genotyping, especially in patients under 30 years old. This indicates the usefulness of p16/Ki-67 testing in the triage of patients with ASCUS/LSIL and <30 years old, prior to referral for colposcopy and biopsy.
由于人乳头瘤病毒（HPV）感染的高瞬时率，HPV 基因分型对高级别宫颈病变的特异性较低，尤其是在年轻女性中。p16/Ki-67 双重免疫细胞化学染色也可用于检测宫颈细胞的致癌变化。我们的目的是比较 p16/Ki-67 双重染色和 HPV 基因分型在检测巴氏涂片 ASCUS/LSIL 患者高级别宫颈病变中的表现。我们回顾性分析了 310 例巴氏涂片 ASCUS/LSIL 的患者，这些患者接受了阴道镜检查。其中，161 例经阴道镜检查怀疑有病变的患者被转诊行活检。在宫颈活检前，采用 LINEAR ARRAY HPV Genotyping Test（CE-IVD）进行 HPV 基因分型，采用 CINtec PLUS Cytology kit 进行 p16/Ki-67 双重染色。在 ASCUS 患者中，HPV 基因分型检测 CIN2-3 的总体敏感性和特异性分别为 79%和 72%，在 LSIL 患者中分别为 85%和 64%。对于 p16/Ki-67 试验，在 ASCUS 患者中，敏感性和特异性分别为 66%和 93%，在 LSIL 组中，敏感性和特异性分别为 59%和 79%。在年龄<30 岁的患者中，p16/Ki-67 染色的特异性明显高于年龄>30 岁的患者（p<0.001）。我们的结果表明，与 HPV 基因分型相比，p16/Ki-67 双重染色具有更高的特异性，尤其是在 30 岁以下的患者中。这表明 p16/Ki-67 检测在年龄<30 岁的 ASCUS/LSIL 患者的分流中具有重要作用，可在转诊阴道镜检查和活检之前使用。
