The effectiveness of HPV viral load, reflected by Cobas 4800 HPV-Ct values for the triage of HPV-positive women in primary cervical cancer screening: Direct endocervical samples
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,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]The Second Hospital of Hebei Medical University, Hebie, China,[5]Fudan University, Huashan Hospital,Shanghai, China,[6]Wuhan University, Zhongnan Hospital, Wuhan, China,[7]Capital Medical University Beijing Tongren Hospital, Beijing, China,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]Peking University People’s Hospital, Beijing, China,[9]Preventive Oncology International, Cleveland Heights, Ohio, United States of America,[10]Women’s Health Institute,Cleveland Clinic, Cleveland, Ohio, United States of America
Objective To explore the relationship between the viral load reflected by the Ct value of Cobas 4800 HPV test and cervical lesions, and the effectiveness of the viral load for secondary triage of HPV-positive women. Methods The Chinese Multi-Center Screening Trial (CHIMUST) evaluated both self-collected samples and physician-collected samples from women, aged 30 to 59, who were screened for cervical cancer in 6 regions across China. Using physician collected samples, the relationship between the HPV-Ct values of different subtypes and the cervical lesions was analyzed. Then the combined use of the HPV-Ct values with the HPV subtypes was evaluated as a secondary screening algorithm for the women who were HPV positive. Results The Ct values of HPV16 and 12 other HPV subtypes(12-type pool), tested with Cobas decreased with the progression of cervical lesion (HPV16: r = -0.429, P<0.001; 12 other HR-HPV subtypes: r = -0.099, P<0.01). The HPV18-Ct value was not correlated with cervical lesion(P>0.05). Compared with HPV16/18 and cytology (HPV16/18 positive and 12-type pool plus cytology. ASC-US), the sequential secondary screening using HPV16/18 and the viral load of 12-type pool (cut-point HPV-Ct <= 31) had equal sensitivities for CIN2+ and CIN3+ (83.1%vs.80.3%,100%vs.92.6%,P>0.05), with slightly lower specificities (96.2% vs.94.4%,96.5%vs.93.9%,P<0.001) and higher colposcopy referral rate (4.90%vs.6.59%, P<0.05), but required no cytology. Conclusion Type-specific HPV viral load is closely related to cervical lesions severity. It is feasible and efficient to use HPV16/18 and the viral load of 12 other HPV subtypes (with cut-point HPV-Ct <= 31) as the secondary screening for HPV positive women. This algorithm may be useful in low resource regions.
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]; China Association for Science and Technology (CN); China International Exchage and Promotion Association for medical and Healthcare
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,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,China,[9]Preventive Oncology International, Cleveland Heights, Ohio, United States of America,[10]Women’s Health Institute,Cleveland Clinic, Cleveland, Ohio, United States of America
推荐引用方式(GB/T 7714)：
Duan Lyufang,Du Hui,Wang Chun,et al.The effectiveness of HPV viral load, reflected by Cobas 4800 HPV-Ct values for the triage of HPV-positive women in primary cervical cancer screening: Direct endocervical samples[J].PLOS ONE.2020,15(5):doi:10.1371/journal.pone.0232107.
APA：
Duan, Lyufang,Du, Hui,Wang, Chun,Huang, Xia,Qu, Xinfeng...&Wu, Ruifang.(2020).The effectiveness of HPV viral load, reflected by Cobas 4800 HPV-Ct values for the triage of HPV-positive women in primary cervical cancer screening: Direct endocervical samples.PLOS ONE,15,(5)
MLA：
Duan, Lyufang,et al."The effectiveness of HPV viral load, reflected by Cobas 4800 HPV-Ct values for the triage of HPV-positive women in primary cervical cancer screening: Direct endocervical samples".PLOS ONE 15..5(2020)
