Objective: To evaluate the performance of Hybribio human papillomavirus (HPV) typing test kit for high risk HPV-DNA typing detection in screening of cervical precancer lesions. Methods: A total of 9 914 women were recruited in Henan, Shanxi, and Guangdong provinces from June to July 2017. All women underwent HPV DNA test. The women who diagnosed as HPV positive and cytological examination ≥ atypical squamous cells of undetermined significance (ASCUS) or HPV negative and cytological examination≥low-grade squamous intraepithelial lesions (LSIL) underwent colposcopy biopsy and pathological examination. Using the pathological diagnosis as the gold standard, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and 95% confidence interval (CI) of high-risk HPV and HPV16/18 tests were calculated. Results: The mean age of 9 914 subjects was (45.0±9.3) years old. Among them, 1 302 subjects were detected as high risk HPV positive, including 211 of HPV16 positive and 64 of HPV18 positive. According to the pathological gold standard of cervical intraepithelial neoplasia grade 2 (CIN2) or worse, the sensitivity and specificity of high risk-HPV and HPV 16/18 for triaging ASCUS women were 90.6% (95%CI: 75.8%-96.8%) and 78.0% (95%CI: 74.5%-81.2%) as well as 56.3% (95%CI: 39.3%-71.8%) and 95.7% (95%CI: 93.8%-97.1%), respectively. The sensitivity and specificity of high risk-HPV and HPV 16/18 for cervical precancer lesions screening were 95.1% (95%CI: 88.1%-98.1%) and 87.6% (95%CI: 86.9%-88.2%) as well as 65.9% (95%CI: 55.1%-75.2%) and 97.8% (95%CI: 97.5%-98.1%), respectively. Conclusions: The Hybribio HPV test kit has a relative high sensitivity and specificity for cervical precancer lesions screening and ASCUS triaging. It is reliable for HPV DNA detection and cervical cancer screening.
目的： 评价凯普人乳头瘤病毒(HPV)分型检测试剂盒用于高危型HPV-DNA分型检测在宫颈癌前病变早期筛查中的应用价值。 方法： 以2017年6—7月在广东、山西、河南三省招募的9 914例(河南省3 233例，山西省3 301例，广东省3 380例)宫颈癌筛查对象作为研究对象，所有研究对象均进行HPV-DNA检测，HPV阳性且细胞学检查结果≥意义不明的不典型鳞状细胞(ASCUS)、HPV阴性且细胞学检查结果≥不典型腺细胞(LSIL)的受试者进行阴道镜检查和活检。以病理学诊断作为金标准，计算高危型HPV和HPV16/18检测的灵敏度、特异度、阳性预测值(PPV)、阴性预测值(NPV)及其95%CI。 结果： 9 914例筛查对象的年龄为(45.0±9.3)岁。其中高危型HPV阳性者1 302例，HPV16阳性者211例，HPV18阳性者64例。以病理检测结果宫颈上皮内瘤变2级及以上(CIN2＋)为金标准，HPV-DNA检测对ASCUS人群的分流效果为高危型HPV型别的灵敏度为90.6%(95%CI为75.8%～96.8%)，特异度为78.0%(95%CI为74.5%～81.2%)；HPV16/18型别合并检测的灵敏度为56.3%(95%CI为39.3%～71.8%)，特异度为95.7%(95%CI为93.8%～97.1%)。HPV-DNA检测对总人群宫颈癌前病变筛查效果为高危型HPV型别的灵敏度为95.1%(95%CI为88.1%～98.1%)，特异度为87.6%(95%CI为86.9%～88.2%)；HPV16/18型别合并检测的灵敏度为65.9%(95%CI为55.1%～75.2%)，特异度为97.8%(95% CI为97.5%～98.1%)。 结论： 凯普HPV检测试剂盒对宫颈癌前病变筛查和ASCUS人群分流具有较高的灵敏度和特异度，是有效的HPV-DNA检测方法，可用于人群中宫颈癌前病变和宫颈癌的筛查。.
Keywords: Cervical intraepithelial neoplasia; Cervical neoplasms; Human papilloma virus; Screening.