Department of Cancer Epidemiology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou 450008, China.
Gynecologic Oncology Department, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, Henan 450008, China.
Anal Cell Pathol (Amst). 2019 Dec 16;2019:4324710. doi: 10.1155/2019/4324710. eCollection 2019.
Human papillomavirus (HPV) testing is widely used in cervical cancer screening in women; however, its efficiency in triaging women with atypical squamous cells of undetermined significance (ASC-US) needs to be validated.
To evaluate the performance of HPV16/18 in the triage of women with ASC-US.
Women presenting for routine cervical cancer screening had cervical specimens collected, with which both liquid-based cytology (LBC) and hrHPVs were examined; those with ASC-US cytology underwent colposcopy. HPV16/18 and 12 other types were tested with domestic hybridization capture and chemiluminescence signal amplification (DH3). Performance characteristics of HPV test (sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) for identification of cervical intraepithelium neoplasma (CIN) grade 2 or worse (CIN2+), and CIN grade 3 or worse (CIN3+)) were determined using standard statistical tests.
317 women with ASC-US were eligible for the study. HrHPV prevalence was 15.77% (50/317); HPV16/18 prevalence was 3.61% (20/317). Sensitivity and specificity of HPV16/18 for detection of CIN 2+ were 64.71% and 97% and 64.29% and 96.37% for detection of CIN 3+, respectively. The positive predictive values (PPVs) and negative predictive values (NPVs) of HPV16/18 were 55.00% and 97.98% for CIN2+ and 45.00% and 98.32% for CIN3+, respectively.
HPV16/18 can be considered as an effective method to triage women with ASC-US as its good clinical performance.
This trial is registered with Henan Cancer Hospital Medical Ethics Committee on July 5, 2016 (http://www.anti-cancer.com.cn), with registry no.: 2016037.
人乳头瘤病毒（HPV）检测在女性宫颈癌筛查中广泛应用，但需要验证其在不典型鳞状细胞意义不明（ASC-US）患者中的分流效率。
评估 HPV16/18 在 ASC-US 患者分流中的作用。
对常规宫颈癌筛查的女性采集宫颈标本，同时进行液基细胞学（LBC）和高风险 HPV 检测；细胞学为 ASC-US 的患者行阴道镜检查。采用国产杂交捕获和化学发光信号放大法（DH3）检测 HPV16/18 和其他 12 种类型。采用标准统计检验确定 HPV 检测的性能特征（敏感性、特异性、阳性预测值（PPV）、阴性预测值（NPV）对识别宫颈上皮内瘤变（CIN）2 级或更高级别（CIN2+）和 CIN 3 级或更高级别（CIN3+）的能力）。
317 例 ASC-US 患者符合研究条件。高危 HPV 患病率为 15.77%（50/317）；HPV16/18 患病率为 3.61%（20/317）。HPV16/18 检测 CIN2+的敏感性和特异性分别为 64.71%和 97%，64.29%和 96.37%检测 CIN3+。HPV16/18 的阳性预测值（PPV）和阴性预测值（NPV）分别为 55.00%和 97.98%用于 CIN2+，45.00%和 98.32%用于 CIN3+。
HPV16/18 可作为 ASC-US 患者分流的有效方法，因其具有良好的临床性能。
本试验于 2016 年 7 月 5 日在河南省肿瘤医院医学伦理委员会注册（http://www.anti-cancer.com.cn），注册号：2016037。
