机构：[1]Department of Gynecology and Obstetrics, Peking University Shenzhen Hospital, Shenzhen, China,北京大学深圳医院深圳市康宁医院深圳医学信息中心[2]Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological Diseases, Shenzhen,PR,China,[3]Sanming Project of Medicine in Shenzhen Peking University Shenzhen Hospital, Shenzhen,China,北京大学深圳医院深圳医学信息中心[4]Department of Gynecology and Obstetrics, The Second Hospital of Hebei Medical University, Hebei,China,[5]Department of Gynecology and Obstetrics, Huashan Hospital North, Fudan University, Shanghai,China,[6]Department of Gynecology and Obstetrics, Zhongnan Hospital of Wuhan University, Wuhan, China,[7]Department of Gynecology and Obstetrics, Capital Medical University Beijing Tongren Hospital, Beijing,PR, China,临床科室妇产科首都医科大学附属北京同仁医院首都医科大学附属同仁医院[8]Department of Gynecology and Obstetrics, Peking University People’s Hospital, Beijing, PR,China,[9]Preventive Oncology International, Cleveland Heights, OH, United States of America,[10]Women’s Health Institute, Cleveland Clinic, Cleveland, OH, United States of America
Objective Evaluate the significance of BMRT HPV assay viral load and its performance for secondary screening. Methods BMRT-HPV reports type-specific viral loads/10,000 cells. We tested 1,495 physician collected, stored specimens from Chinese Multiple-center Screening Trial (CHIMUST), that were positive by Cobas, SeqHPV, and/or Cytology (>= LSIL); and 2,990 age matched, negatives in a nested case control study. We explored the relationship between BMRT HR-HPV viral load and cervical lesions, determined alternative CIN2+ cut-points by ROC curve, and evaluated BMRT HR-HPV for primary / secondary cervical cancer screening. Results The viral loads of HPV16/18, 12 other subtypes HR-HPV and 14 HR-HPV were statistically different in all grades of cervical lesions (P < 0.05, among which HPV16, 33 and 58 showed the strongest relationship (P < 0.01). The viral load of HR-HPV also increased with the grade of cervical lesions (P < 0.05). The sensitivity for CIN2+ and CIN3+ of BMRT was comparable to Cobas (92.6% vs 94.3%, 100% vs 100%, P> 0.05), specificity was higher than Cobas (84.8% vs 83.3%, 83.5% vs 82.0%, P< 0.001). When using HPV16/18 viral load(log cutpoint.3.2929), plus the viral-load of 12 other subtypes (log cut-point >= 3.9625) as secondary triage, compared with Cobas HPV16/18+ plus cytology >= ASC-US as triage, the sensitivities for CIN2+ and CIN3+ were similar (P>0.05). However, the BMRT HR-HPV viral load combined with subtypes did not require cytology. Conclusion BMRT is as sensitive as Cobas4800 for primary cervical cancer screening. BMRT HR-HPV viral load combined with subtypes can be used as a secondary strategy for cervical cancer screening, especially for areas with insufficient cytological resources.
基金：
Shenzhen Health Family Planning Commission, Shenzhen, PR China [SZLY2017005]; Sanming Project of Medicine in Shenzhen [SZSM201412010]; Shenzhen Key Laboratory of Neuropsychiatric Modulation (CN) Science and Education of Shenzhen Health [[2018]61]
第一作者机构：[1]Department of Gynecology and Obstetrics, Peking University Shenzhen Hospital, Shenzhen, China,[2]Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological Diseases, Shenzhen,PR,China,
共同第一作者：
通讯作者：
通讯机构：[1]Department of Gynecology and Obstetrics, Peking University Shenzhen Hospital, Shenzhen, China,[2]Shenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecological Diseases, Shenzhen,PR,China,[9]Preventive Oncology International, Cleveland Heights, OH, United States of America,[10]Women’s Health Institute, Cleveland Clinic, Cleveland, OH, United States of America
推荐引用方式(GB/T 7714)：
Duan Lyufang,Du Hui,Wang Chun,et al.The application of BMRT-HPV viral load to secondary screening strategies for cervical cancer[J].PLOS ONE.2020,15(5):doi:10.1371/journal.pone.0232117.
APA：
Duan, Lyufang,Du, Hui,Wang, Chun,Huang, Xia,Qu, Xinfeng...&Wu, Ruifang.(2020).The application of BMRT-HPV viral load to secondary screening strategies for cervical cancer.PLOS ONE,15,(5)
MLA：
Duan, Lyufang,et al."The application of BMRT-HPV viral load to secondary screening strategies for cervical cancer".PLOS ONE 15..5(2020)
