高性能人乳头瘤病毒检测对改善中国宫颈癌筛查的影响：一项前瞻性基于人群的多中心队列研究。
Impact of high-performance human papillomavirus testing to improve cervical cancer screening in China: a prospective population-based multicentre cohort study.
机构信息
School of Population Medicine and Public Health, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China; Department of Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of Cancer Prevention and Control, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.
出版信息
Clin Microbiol Infect. 2024 Sep;30(9):1190-1196. doi: 10.1016/j.cmi.2024.03.035. Epub 2024 Apr 8.
OBJECTIVES
The aim of the study was to evaluate the clinical performance of HBRT-H14, a real-time PCR-based assay that separates human papillomavirus (HPV) 16 and HPV18 from 12 other high-risk (HR) HPV types, in population according to Chinese guideline.
METHODS
A total of 9829 eligible women aged 21-64 years from Henan, Shanxi, and Guangdong provinces were performed by HBRT-H14 testing and liquid-based cytology (LBC) screening at baseline and followed up for 3-year. The sensitivity, specificity, positive predictive value (absolute risk), and negative predictive value of LBC diagnosis and HPV testing were calculated for cervical intraepithelial neoplasia grade 2 or worse (CIN2+) Lesions.
RESULTS
At baseline, 80 (0.81%) participants were diagnosed with CIN2+. HR-HPV with reflex LBC had a significantly higher sensitivity (78/80, 97.50% [95% CI, 91.34-99.31%] vs. 62/80, 77.50% [67.21-85.27%], McNemar's test p < 0.001), and a slightly lower specificity (8528/9749, 87.48% [86.80-88.12%] vs. 8900/9749, 91.29% [90.72-91.83%], McNemar's test p < 0.001) than LBC with reflex HR-HPV for CIN2+. 7832 (79.6%) participants completed 3-year follow-up and 172 (2.20%) participants were cumulatively diagnosed with CIN2+. Compared with LBC with reflex HR-HPV, HR-HPV with reflex LBC significantly increased the sensitivity (161/172, 93.60% [88.91-96.39%] vs. 87/172, 50.58% [43.18-57.96%], McNemar's test p < 0.001), but marginally decreased the specificity (6776/7660, 88.46% [87.72-89.16%] vs. 6933/7660, 90.51% [89.83-91.15], McNemar's test p < 0.001). In addition, the absolute 3-year risk of CIN2+ in HPV16/18-positive individuals was as high as 33% (80/238), whereas the risk in the HPV-negative population was only 0.16% (11/6787), much lower than those in the negative for intraepithelial lesion or malignancy population (1.21%, 85/7018). Moreover, similar results were found in women ≥30 years old.
DISCUSSION
The study has indicated that HBRT-14 has a reliable clinical performance for use in cervical screening. The validated HPV test would improve the quality of population screening.
目的
本研究旨在评估 HBRT-H14 的临床性能，该方法基于实时 PCR 技术，可将人乳头瘤病毒（HPV）16 和 HPV18 与其他 12 种高危型 HPV 类型区分开来，适用于中国指南规定的人群。
方法
本研究共纳入来自河南、山西和广东省的 9829 名年龄在 21-64 岁的合格女性，在基线时进行 HBRT-H14 检测和液基细胞学（LBC）筛查，并进行为期 3 年的随访。对于宫颈上皮内瘤变 2 级或更高级别（CIN2+）病变，计算 LBC 诊断和 HPV 检测的灵敏度、特异性、阳性预测值（绝对风险）和阴性预测值。
结果
在基线时，80 名（0.81%）参与者被诊断为 CIN2+。HR-HPV 联合 LBC 的检测具有更高的灵敏度（78/80，97.50%[91.34-99.31%] vs. 62/80，77.50%[67.21-85.27%]，McNemar 检验 p<0.001），但特异性略低（8528/9749，87.48%[86.80-88.12%] vs. 8900/9749，91.29%[90.72-91.83%]，McNemar 检验 p<0.001）。7832 名（79.6%）参与者完成了 3 年随访，172 名（2.20%）参与者累积诊断为 CIN2+。与 LBC 联合 HR-HPV 相比，HR-HPV 联合 LBC 显著提高了灵敏度（161/172，93.60%[88.91-96.39%] vs. 87/172，50.58%[43.18-57.96%]，McNemar 检验 p<0.001），但特异性略有下降（6776/7660，88.46%[87.72-89.16%] vs. 6933/7660，90.51%[89.83-91.15%]，McNemar 检验 p<0.001）。此外，HPV16/18 阳性个体的 3 年 CIN2+绝对风险高达 33%（80/238），而 HPV 阴性人群的风险仅为 0.16%（11/6787），远低于非上皮内病变或恶性肿瘤人群（1.21%，85/7018）。此外，≥30 岁女性也有类似的结果。
讨论
本研究表明 HBRT-14 具有可靠的临床性能，可用于宫颈癌筛查。经过验证的 HPV 检测将提高人群筛查的质量。
Zotero 插件