{
  "abstract": "Abstract Objective To compare the diagnostic accuracy of minipad collected menstrual blood versus clinician collected cervical samples to test for human papillomavirus (HPV) in the detection of cervical intraepithelial neoplasia grade 2/3 or worse (CIN2+/CIN3+).Design Cross sectional population based study.Setting Four urban and three rural communities in Hubei Province, China.Participants 3068 women aged 20-54 years with regular menstrual cycles, enrolled between September 2021 and January 2025.Interventions HPV testing using minipad collected menstrual blood, clinician collected cervical samples, and ThinPrep cytology. Women who tested HPV positive by either collection method or by cytology (atypical squamous cells of undetermined significance or worse) were referred for colposcopy directed biopsy sampling.Main outcome measure Diagnostic accuracy for detecting CIN2+ and CIN3+.Results Among 3068 participants, minipad based HPV testing showed a sensitivity of 94.7% (95% confidence interval 80.9% to 99.1%) for CIN2+ detection, comparable to clinician based HPV testing (92.1%, 77.5% to 97.9%; P=1.00). Although minipad HPV testing showed a lower specificity than clinician HPV testing (89.1%, 88.0% to 90.2% v 90.0%, 88.9% to 91.1%; P=0.001), the negative predictive value matched that of clinician HPV testing (99.9%, 99.7% to 100.0% v 99.9%, 99.7% to 100.0%; P=1.00). Both collection methods had a similar positive predictive value (9.9%, 7.1% to 13.5% v 10.4%, 7.4% to 14.3%; P=0.82) and screening efficiency (10.1 v 9.6 referrals per CIN2+ detected; P=0.82).Conclusions Minipad collected menstrual blood showed comparable diagnostic accuracy to clinician collected cervical samples for HPV testing for detecting CIN2+ and CIN3+.Trial registration ClinicalTrials.gov NCT06082765.",
  "authors": [
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, Academician Expert Workstation, the Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China"
      ],
      "name": "Xun Tian"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, Academician Expert Workstation, the Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China"
      ],
      "name": "Chen Cao"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, Academician Expert Workstation, the Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China"
      ],
      "name": "Lejing Wang"
    },
    {
      "affiliations": [
        "Department of Gynecologic Oncology, Women and Children’s Hospital Affiliated with Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071 China"
      ],
      "name": "Jingjing Zhang"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, the Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China"
      ],
      "name": "Ye Chen"
    },
    {
      "affiliations": [
        "Generulor Company Bio-X Lab, Zhuhai, Guangdong, China"
      ],
      "name": "Rui Tian"
    },
    {
      "affiliations": [
        "Department of Gynecologic Oncology, Women and Children’s Hospital Affiliated with Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071 China"
      ],
      "name": "Bo Zhou"
    },
    {
      "affiliations": [
        "Department of Gynecologic Oncology, Women and Children’s Hospital Affiliated with Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071 China"
      ],
      "name": "Lili Sun"
    },
    {
      "affiliations": [
        "Department of Gynecologic Oncology, Women and Children’s Hospital Affiliated with Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071 China"
      ],
      "name": "Caixia Zhang"
    },
    {
      "affiliations": [
        "Department of Gynecologic Oncology, Women and Children’s Hospital Affiliated with Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071 China"
      ],
      "name": "Lijuan Gan"
    },
    {
      "affiliations": [
        "Department of Gynecologic Oncology, Women and Children’s Hospital Affiliated with Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071 China"
      ],
      "name": "Yu Jin"
    },
    {
      "affiliations": [
        "Department of Gynecologic Oncology, Women and Children’s Hospital Affiliated with Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071 China"
      ],
      "name": "Jiahui Liu"
    },
    {
      "affiliations": [
        "Department of Operation, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China"
      ],
      "name": "Ting Wang"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, Academician Expert Workstation, the Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China"
      ],
      "name": "Yanqing Shen"
    },
    {
      "affiliations": [
        "Health Management Center, the Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China"
      ],
      "name": "Sisi Huang"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, Huanggang Maternal and Child Health Care Hospital, Huanggang, Hubei, China"
      ],
      "name": "Ling Zhang"
    },
    {
      "affiliations": [
        "Department of Gynecology, the First People’s Hospital of Tianmen, Tianmen, Hubei, China"
      ],
      "name": "Shenhua Zhang"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, Huangmei County People’s Hospital, Huanggang, Hubei, China"
      ],
      "name": "Ping Chen"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, Zhongxiang Maternal and Child Health Care Hospital, Zhongxiang, Hubei, China"
      ],
      "name": "Chunli Tong"
    },
    {
      "affiliations": [
        "Department of Gynecology, People’s Hospital of Zhongxiang, Zhongxiang, Hubei, China"
      ],
      "name": "Jiaqi Kang"
    },
    {
      "affiliations": [
        "Department of Gynecology, People’s Hospital of Yingshan County, Huanggang, Hubei, China"
      ],
      "name": "Hongli Fan"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, Wu Xue First People’s Hospital, Huanggang, Hubei, China"
      ],
      "name": "Guocheng Zhou"
    },
    {
      "affiliations": [
        "Department of Gynecological Oncology, Huangmei Maternal and Child Health Care Hospital, Huanggang, Hubei, China"
      ],
      "name": "Liming Xiang"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, Gucheng County People’s Hospital, Xiangyang, Hubei, China"
      ],
      "name": "Yu Wen"
    },
    {
      "affiliations": [
        "Department of Gynecology, Dawu People’s Hospital, Xiaogan, Hubei, China"
      ],
      "name": "Ruiliu Gan"
    },
    {
      "affiliations": [
        "Department of Gynecology, Jingshan Union Hospital, Union Hospital, Huazhong University of Science and Technology, Jingshan, Hubei, China"
      ],
      "name": "Yong Chen"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, the Second People’s Hospital of China Three Gorges University the Second People’s Hospital of Yichang, Yichang, Hubei, China"
      ],
      "name": "Xiaolan Li"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, Zaoyang Maternal and Child Health Care Hospital, Zaoyang, Hubei, China"
      ],
      "name": "Li Zhai"
    },
    {
      "affiliations": [
        "Department of Obstetrics and Gynecology, Academician Expert Workstation, the Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China"
      ],
      "name": "Qinghua Zhang"
    },
    {
      "affiliations": [
        "Department of Gynecological Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China",
        "National Clinical Research Center for Obstetrics and Gynecology, Cancer Biology Research Center (Key Laboratory of the Ministry of Education), Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China"
      ],
      "name": "Ding Ma"
    },
    {
      "affiliations": [
        "Department of Gynecological Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China",
        "National Clinical Research Center for Obstetrics and Gynecology, Cancer Biology Research Center (Key Laboratory of the Ministry of Education), Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China"
      ],
      "name": "Zhiqiang Han"
    },
    {
      "affiliations": [
        "Department of Gynecologic Oncology, Women and Children’s Hospital Affiliated with Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071 China",
        "Taikang Center for Life and Medical Sciences, Wuhan University, Wuhan, Hubei, 430072 China",
        "Hubei Key Laboratory of Tumor Biological Behavior, Hubei Provincial Clinical Research Center for Cancer, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, 430071 China",
        "School of nursing, Research Center for Lifespan Health, Wuhan University, Wuhan, Hubei, 430072 China"
      ],
      "name": "Zheng Hu"
    }
  ],
  "title": "Testing menstrual blood for human papillomavirus during cervical cancer screening in China: cross sectional population based study",
  "uid": "52ecd307-0ebf-5629-8d55-65ab33cd44cc"
}