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[目的]验证高危型人乳头状瘤病毒第二代杂交捕获试验(hybridcaptureⅡ,HC-Ⅱ)作为初筛方法检出宫颈病变(≥CINⅡ)的灵敏度和特异度,从而评价HC-Ⅱ检测的临床有效性。[方法]分别以自然人群(山西省襄垣县、沁县)和医院门诊(中日友好医院、北京大学第三医院)妇女为筛查对象的横断面研究,以病理诊断为金标准,开展HC-Ⅱ检测方法的临床验证。筛查对象接受检查时,依次留取Autocyteprep液基细胞学(LCT)和HC-Ⅱ检测标本,并对以上任一项异常者召回行阴道镜下检查和/或活检。[结果]1285例中高危型HPV感染339例,占26.4%;阴性946例,占73.6%。其中在1059例自然人群中高危型HPV感染163例,占15.4%;阴性896例,占84.6%;而在226例医院门诊病例中高危型HPV感染176例,占77.9%;阴性50例,占22.1%。最终参加HC-Ⅱ验证统计分析的共1273例,其中病理诊断≥CINⅡ的160例,HPV阳性同时病理诊断≥CINⅡ的157例。HC-Ⅱ检测样本的灵敏度和特异度分别为98.1%(157/160)和84.5%(941/1113)。阴性预测值和阳性预测值分别为99.7%(941/944)和47.7%(157/329)。[结论]HC-Ⅱ检测技术的验证研究结果显示HC-Ⅱ检测灵敏度高、特异度好,可用于宫颈癌及其癌前病变的筛查。
[Objective] To verify the sensitivity and specificity of detection of cervical lesions (≥CINⅡ) by hybrid capture Ⅱ (HC-Ⅱ) of high-risk human papillomavirus (HPV) Effectiveness. [Methods] The cross-sectional study on women who were from natural population (Xiangyuan County, Qin County, Shanxi Province) and outpatient clinic (Sino-Japan Friendship Hospital, Peking University Third Hospital) as the screening target, pathological diagnosis as the gold standard, HC -Ⅱ test method of clinical validation. Subjects under screening, followed by Autocyteprep liquid-based cytology (LCT) and HC-Ⅱ test specimens, and for any of the above abnormalities were recalled colposcopy and / or biopsy. [Results] There were 339 cases of high-risk HPV infection in 1285 cases, accounting for 26.4%; negative 946 cases, accounting for 73.6%. In 1059 cases, 163 cases were high-risk HPV infection, accounting for 15.4%; 896 cases were negative, accounting for 84.6%; 176 cases were high-risk HPV infection in 226 outpatient cases, accounting for 77.9%; negative in 50 cases 22.1%. A total of 1273 patients were enrolled in the statistical analysis of HC-Ⅱ. Among them, 160 cases were pathologically diagnosed ≥CINⅡ, 157 cases were positive for HPV and ≥CINⅡ was diagnosed. The sensitivity and specificity of HC-Ⅱ test samples were 98.1% (157/160) and 84.5% (941/1113), respectively. The negative predictive value and positive predictive value were 99.7% (941/944) and 47.7% (157/329), respectively. [Conclusion] The validation results of HC-Ⅱ detection technology show that HC-Ⅱ has high sensitivity and specificity, which can be used for screening cervical cancer and precancerous lesions.