Dong Binhua, Chen Lihua, Lin Wenyu, Su Yingying, Mao Xiaodan, Pan Diling, Ruan Guanyu, Xue Huifeng, Kang Yafang, Sun Pengming
Department of Gynecology, Laboratory of Gynecologic Oncology, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, 18 Daoshan Road, Fuzhou, 350001 Fujian People's Republic of China.
Fujian Key Laboratory of Women and Children's Critical Diseases Research, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, 350001 Fujian People's Republic of China.
Cancer Cell Int. 2020 Aug 28;20:421. doi: 10.1186/s12935-020-01512-4. eCollection 2020.
New screening techniques may affect the optimal approaches for the prevention of cervical cancer. We evaluated the cost-effectiveness and accuracy of alternative screening strategies to provide evidence for cervical cancer screening guidelines in China.
In total, 32,306 women were enrolled. The current screening with Cervista high-risk human papillomavirus (HR-HPV) nongenotyping and cytology cotesting (Cervista cotesting) was compared with PCR-reverse dot blot HR-HPV genotyping and cytology cotesting (PCR-RDB cotesting). All eligible participants were divided into Arm 1, in which both HR-HPV assays were performed, and Arms 2 and 3, in which the PCR-RDB HPV or Cervista HR-HPV assay, respectively, was performed. Outcome indicators included the cases, sensitivity, negative predictive value (NPV), colposcopy referral rate and cost of identifying cervical intraepithelial neoplasia of grade 2/3 or worse (CIN2+/CIN3+).
Among the eligible participants, 18.4% were PCR-RDB HR-HPV-positive, while 16.9% were Cervista HR-HPV-positive, which reflects good agreement (k = 0.73). PCR-RDB cotesting identified more CIN3+ cases than Cervista cotesting in the first round of screening in Arm 1 (37 vs 32) and Arms 2/3 (252 vs 165). The sensitivity and NPV of PCR-RDB cotesting for identifying CIN3+ in Arm 1 (sensitivity: 94.9% vs 86.5%; NPV: 99.9% vs 99.7%) and Arms 2/3 (sensitivity: 95.1% vs 80.9%; NPV: 99.9% vs 99.6%) were higher than those of Cervista cotesting, but the cost was similar.
The PCR-RDB HR-HPV genotyping and Cervista HR-HPV assay results were consistent. PCR-RDB cotesting possesses optimal cost-effectiveness for cervical cancer screening in China, which has the highest number of cases globally but low screening coverage.
新的筛查技术可能会影响预防宫颈癌的最佳方法。我们评估了替代筛查策略的成本效益和准确性，以为中国宫颈癌筛查指南提供依据。
总共纳入了32306名女性。将目前使用Cervista高危型人乳头瘤病毒（HR-HPV）非基因分型与细胞学联合检测（Cervista联合检测）的筛查方法，与聚合酶链反应-反向点杂交HR-HPV基因分型与细胞学联合检测（PCR-RDB联合检测）进行比较。所有符合条件的参与者被分为第1组，即同时进行两种HR-HPV检测；以及第2组和第3组，分别进行PCR-RDB HPV检测或Cervista HR-HPV检测。结果指标包括病例数、灵敏度、阴性预测值（NPV）、阴道镜转诊率以及识别2/3级或更高级别宫颈上皮内瘤变（CIN2+/CIN3+）的成本。
在符合条件的参与者中，18.4%的人PCR-RDB HR-HPV呈阳性，而16.9%的人Cervista HR-HPV呈阳性，这反映出两者具有良好的一致性（κ=0.73）。在第1组（37例对32例）以及第2/3组（252例对165例）的第一轮筛查中，PCR-RDB联合检测识别出的CIN3+病例比Cervista联合检测更多。PCR-RDB联合检测在第1组（灵敏度：94.9%对86.5%；NPV：99.9%对99.7%）以及第2/3组（灵敏度：95.1%对80.9%；NPV：99.9%对99.6%）中识别CIN3+的灵敏度和NPV高于Cervista联合检测，但成本相似。
PCR-RDB HR-HPV基因分型和Cervista HR-HPV检测结果一致。PCR-RDB联合检测在中国宫颈癌筛查中具有最佳的成本效益，中国是全球宫颈癌病例数最多但筛查覆盖率较低的国家。
