p16/Ki-67 Dual-Stain Cytology in the Triage of ASCUS and LSIL Papanicolaou Cytology Results From the European Equivocal or Mildly Abnormal Papanicolaou Cytology Study
p16/Ki-67 Dual-Stain Cytology in the Triage of ASCUS and LSIL Papanicolaou Cytology Results From the European Equivocal or Mildly Abnormal Papanicolaou Cytology Study
复制标题
DOI：
10.1002/cncy.20140
复制
发表时间：
2011-06-25
影响因子：
3.4
通讯作者：
Ridder, Ruediger
中科院分区：
文献类型：
--
作者：
Schmidt, Dietmar;Bergeron, Christine;Ridder, Ruediger
背景技术背景：本研究的目的是分析新建立的免疫细胞化学双染色方案的诊断性能，该方案同时检测宫颈细胞学样本中p16（INK 4a）和Ki-67的表达，用于在巴氏（Pap）细胞学检查结果分类为意义不明的非典型鳞状细胞（ASCUS）或低级别鳞状细胞的女性中识别高度宫颈上皮内瘤变（CIN 2+）。分级鳞状上皮内病变（LSIL）。方法：对776例回顾性收集的ASCUS/LSIL病例的残留液基细胞学材料进行p16/Ki-67双重染色，这些材料来自最近一项评估p16细胞学和HPV检测的研究。无论形态如何，存在1个或多个双重免疫反应性细胞均视为阳性检测结果。测试结果与组织学随访相关。研究结果：p16/Ki-67双染色细胞学诊断活检证实的CIN 2+的敏感性分别为92.2%（ASCUS）和94.2%（LSIL），特异性分别为80.6%（ASCUS）和68.0%（LSIL）。年龄≥ 30岁的两个年龄组女性的敏感性/特异性特征相似< 30 years versus women aged >。与人乳头瘤病毒（HPV）检测相比，双染色细胞学检查显示出相当的敏感性，但特异性显着更高。结论：这项研究的结果表明，p16/Ki-67双染色细胞学检查为检测ASCUS或LSIL Pap细胞学结果的女性中潜在的CIN 2+提供了高灵敏度，与之前报道的HPV检测和p16单染色细胞学检查的比率相当。然而，与早期的p16单染色细胞学方法（需要形态学解释）相比，p16/Ki-67双染色细胞学检测的这种形态学独立解释的特异性进一步提高，并且与HPV检测相比，它显著更高。癌症（癌症细胞病理学）2011;119158-66。(C)2011年美国癌症协会
BACKGROUND: The objective of this study was to analyze the diagnostic performance of a newly established immunocytochemical dual-stain protocol, which simultaneously detects p16(INK4a) and Ki-67 expression in cervical cytology samples, for identifying high-grade cervical intraepithelial neoplasia (CIN2+) in women with Papanicolaou (Pap) cytology results categorized as atypical squamous cells of undetermined significance (ASCUS) or low-grade squamous intraepithelial lesions (LSIL). METHODS: Residual liquid-based cytology material from 776 retrospectively collected ASCUS/LSIL cases that were available from a recent study evaluating p16 cytology and HPV testing were subjected to p16/Ki-67 dual staining. The presence of 1 or more double-immunoreactive cell(s) was regarded as a positive test outcome, irrespective of morphology. Test results were correlated to histology follow-up. RESULTS: Sensitivity of p16/Ki-67 dual-stain cytology for biopsy-confirmed CIN2+ was 92.2% (ASCUS) and 94.2% (LSIL), while specificity rates were 80.6% (ASCUS) and 68.0% (LSIL), respectively. Similar sensitivity/specificity profiles were found for both age groups of women aged < 30 years versus women aged >= 30 years. Dual-stain cytology showed comparable sensitivity, but significantly higher specificity, when compared with human papillomavirus (HPV) testing. CONCLUSIONS: The results of this study show that p16/Ki-67 dual-stain cytology provided a high sensitivity for the detection of underlying CIN2+ in women with ASCUS or LSIL Pap cytology results, comparable to the rates previously reported for HPV testing and p16 single-stain cytology. However, the specificity of this morphology-independent interpretation of p16/Ki-67 dual-stain cytology testing was further improved compared with the earlier p16 single-stain cytology approach, which required morphology interpretation, and it is significantly higher when compared with HPV testing. Cancer (Cancer Cytopathol) 2011;119158-66. (C) 2011 American Cancer Society.