Accuracy of triage strategies for human papillomavirus DNA-positive women in low-resource settings:A cross-sectional study in China

Objective： CareHPV is a human papillomavirus （HPV） DNA test for low-resource settings （LRS）. This study assesses optimum triage strategies for careHPV-positive women in LRS. Methods： A total of 2,530 Chinese women were concurrently screened for cervical cancer with visual inspection with acetic acid （VIA）, liquid-based cytology and HPV testing by physician- and self-collected careHPV, and physician-collected Hybrid Capture 2 （HC2）. Screen-positive women were referred to colposcopy with biopsy and endocervical curettage as necessary. HPV-positivity was defined as _〉1.0 relative light units/cutoff （RLU/CO） for both careHPV and HC2. Primary physician-HC2, physician-careHPV and self-careHPV and in sequential screening with cytology, VIA, or increased HPV test-positivity performance, stratified by age, were assessed for cervical intraepithelial neoplasia （CIN） grade 2/3 or worse （CIN2/3＋） detection. Results： The sensitivities and specificities of primary HPV testing for CIN2＋ were： 83.8%, 88.1% for physician- careHPV; 72. 1%, 88.2% for self-careHPV; and 97.1%, 86.0% for HC2. Physician-careHPV test-positive women with VIA triage had a sensitivity of 30.9% for CIN2＋ versus 80.9% with cytology triage. Self-careHPV test- positive women with VIA triage was 26.5% versus 66.2 % with cytology triage. The sensitivity of HC2 test-positive women with VIA triage was 38.2 % versus 92.6% with cytology triage. The sensitivity of physician-careHPV testing for CIN2＋ decreased from 83.8% at _〉1.0 RLU/CO to 72.1% at _〉10.00 RLU/CO, while the sensitivity of self- careHPV testing decreased from 72.1% at _〉1.0 RLU/CO to 32.4% at _〉10.00 RLU/CO; similar trends were seen with age-stratification. Conclusions： VIA and cytology triage improved specificity for CIN2/3 than no triage. Sensitivity with VIA triage was unsuitable for a mass-screening program. VIA provider training might improve this strategy. Cytology triage could be feasible where a high-quality cytology program exists. Triage of HPV test-positive women by increased test positivity cutoff adds another LRS triage option.

高危型人乳头瘤病毒核酸检测试剂盒-Care HPV用于宫颈癌及癌前病变筛查的临床价值

目的 评价care HPV用于宫颈癌及癌前病变筛查的临床价值。方法 收集2010年至2012年南京鼓楼医院妇科就诊的年龄在30~59岁之间的妇女宫颈样本,行care HPV、第二代杂交捕获技术（HC2）、HPV聚合酶链反应（HPV-PCR）及宫颈液基细胞学（TCT）检查,TCT≥ASC-US者行阴道镜宫颈活检及必要时宫颈管诊刮,以组织病理学为金标准。病理诊断≥CIN2者为高危病变组,炎症/CCIN 1为良性病变组。结果 共收集404例有效样本。高危组42例、良性组50例,正常组312例。care HPV和HC2检测结果 的一致性为Kappa=0.833（P〈0.0001）,一致率93.81%;care HPV和HPV-PCR检测结果 的一致性为Kappa=0.707（P〈0.0001）,一致率88.12%;care HPV检出≥CIN 2的灵敏度为85.71%,特异度为83.15%。结论 care HPV与HC2、HPV-PCR试剂具有高度一致性。care HPV在检出HPV感染上具有很好的灵敏度和特异性,检测耗时短,有望成为医疗资源相对贫乏地区子宫颈癌及癌前病变筛查的主要方法 。