Department of Obstetrics and Gynecology, Cheil General Hospital and Women's Healthcare Center, Kwandong University College of Medicine, Seoul, South Korea.
Virchows Arch. 2013 Nov;463(5):689-96. doi: 10.1007/s00428-013-1483-4. Epub 2013 Oct 1.
This study was conducted to evaluate the accuracy of p16/Ki-67 dual immunostaining compared to high-risk human papillomavirus (HR-HPV) DNA testing for cervical intraepithelial neoplasia (CIN) in women with atypical squamous cells, cytology not excluding high-grade squamous intraepithelial lesion (ASC-H). Data were collected from 73 patients diagnosed to have ASC-H on a Pap smear who were HPV genotyped and had histological examination of a cervical biopsy. The CINtecPLUS kit was used on residual liquid-based material, and the immunoreactivity of dual-stained cells was graded according to the number as follows: G1 (1-5 positive cells), G2 (6-10), G3 (11-20), and G4 (> 20). Accuracy was evaluated based on the histological examination of colposcopy-guided biopsy or cervical conization on follow-up. Of the 70 patients with available data, positive p16/Ki-67 was associated with histological severity as follows: 15% in negative histology, 67% in CIN 1, 90% in CIN 2, and 100% in CIN 3. The average grade of positive p16/Ki-67 staining also increased from 0.2 in histologically negative cases to 1.2 in CIN 1, 2.4 in CIN 2, and 2.9 in CIN 3 (p < 0.01). For patients with CIN 2 or higher, p16/Ki-67 had a sensitivity of 94.6% and a specificity of 75.8%, while HR-HPV testing showed a sensitivity of 67.6% and a specificity of 66.7%. p16/Ki-67 immunostaining demonstrated better accuracy than HR-HPV for detecting CIN 2 or higher in patients with ASC-H cytology. Given the higher concordance with histological diagnosis, the grading system of positive p16/Ki-67 can be a useful adjunct for predicting high-grade lesions in clinical practice.
本研究旨在评估 p16/Ki-67 双重免疫染色在细胞学不排除高级别鳞状上皮内病变(ASC-H)的非典型鳞状细胞的女性中用于评估宫颈上皮内瘤变(CIN)的准确性,与高危型人乳头瘤病毒(HR-HPV)DNA 检测相比。数据来自 73 名经巴氏涂片诊断为 ASC-H 的患者,这些患者接受了 HPV 基因分型,并对宫颈活检进行了组织学检查。在剩余的液基材料上使用 CINtecPLUS 试剂盒,并根据数量对双重染色细胞的免疫反应进行分级,如下所示:G1(1-5 个阳性细胞)、G2(6-10 个)、G3(11-20 个)和 G4(>20 个)。准确性是根据阴道镜引导下活检或宫颈锥切术的组织学检查结果进行评估的。在有可用数据的 70 名患者中,p16/Ki-67 阳性与组织学严重程度如下相关:阴性组织学 15%、CIN1 67%、CIN2 90%和 CIN3 100%。阳性 p16/Ki-67 染色的平均等级也从组织学阴性病例的 0.2 增加到 CIN1 的 1.2、CIN2 的 2.4 和 CIN3 的 2.9(p<0.01)。对于 CIN2 或更高的患者,p16/Ki-67 的敏感性为 94.6%,特异性为 75.8%,而 HR-HPV 检测的敏感性为 67.6%,特异性为 66.7%。p16/Ki-67 免疫染色在 ASC-H 细胞学患者中检测 CIN2 或更高的准确性优于 HR-HPV。鉴于与组织学诊断的一致性更高,阳性 p16/Ki-67 的分级系统可作为预测临床实践中高级别病变的有用辅助手段。