Context. 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. Objective. To evaluate the performance of HPV16/18 in the triage of women with ASC-US. Methods. 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. Results. 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. Conclusion. HPV16/18 can be considered as an effective method to triage women with ASC-US as its good clinical performance. Trial Registration. 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.

中文翻译：

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HPV16/18 在未确定意义的细胞学非典型鳞状细胞分类中的表现。


语境。人乳头瘤病毒（HPV）检测广泛用于女性宫颈癌筛查；然而，其对患有未确定意义的非典型鳞状细胞 (ASC-US) 的女性进行分类的效率需要验证。客观的。评估 HPV16/18 在 ASC-US 女性分诊中的表现。方法。接受常规宫颈癌筛查的女性采集了宫颈标本，并对液基细胞学 (LBC) 和 hrHPV 进行了检查；接受 ASC-US 细胞学检查的患者接受了阴道镜检查。采用国产杂交捕获和化学发光信号放大（DH3）技术对HPV16/18及其他12型进行检测。 HPV 检测的性能特征（识别宫颈上皮内肿瘤 (CIN) 2 级或更差 (CIN2+) 和 CIN 3 级或更差 (CIN3+) 的敏感性、特异性、阳性预测值 (PPV)、阴性预测值 (NPV)）使用标准统计测试确定。结果。 317 名患有 ASC-US 的女性有资格参加这项研究。 HrHPV 患病率为 15.77% (50/317)； HPV16/18 患病率为 3.61% (20/317)。 HPV16/18检测CIN 2+的敏感性和特异性分别为64.71%和97%，检测CIN 3+的敏感性和特异性分别为64.29%和96.37%。 HPV16/18的阳性预测值（PPV）和阴性预测值（NPV）对于CIN2+分别为55.00%和97.98%，对于CIN3+分别为45.00%和98.32%。结论。 HPV16/18因其良好的临床表现而被认为是对ASC-US女性进行分流的有效方法。试用注册。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。