PMID- 34940863 OWN - NLM STAT- MEDLINE DCOM- 20220117 LR - 20220117 IS - 2574-3805 (Electronic) IS - 2574-3805 (Linking) VI - 4 IP - 12 DP - 2021 Dec 1 TI - Feasibility and Accuracy of Menstrual Blood Testing for High-risk Human Papillomavirus Detection With Capture Sequencing. PG - e2140644 LID - 10.1001/jamanetworkopen.2021.40644 [doi] LID - e2140644 AB - IMPORTANCE: High-risk human papillomavirus (hrHPV) persistent infection is the major etiology of cervical precancer and cancer. Noninvasive self-sampling HPV testing is a promising alternative cervical cancer screening for avoiding stigma and improving patient willingness to participate. OBJECTIVE: To investigate the feasibility and accuracy of menstrual blood (MB) hrHPV capture sequencing in hrHPV detection. DESIGN, SETTING, AND PARTICIPANTS: This cohort study collected 137 sanitary pads from 120 women who were premenopausal and had hrHPV as detected by cervical HPV GenoArray testing. Patients were recruited from September 1, 2020, to April 1, 2021, at Central Hospital of Wuhan, China. Target capture sequencing was performed to determine hrHPV genotypes in MB. Sanger sequencing was performed as the criterion standard for detecting hrHPV genotypes among enrolled women. Data were analyzed from April 1 through June 1, 2021. MAIN OUTCOMES AND MEASURES: Complete concordance, incomplete concordance, and discordance of MB hrHPV capture sequencing and conventional HPV testing were defined according to genotype overlapping levels. Concordance of the 2 detection methods and comparative power of MB hrHPV capture sequencing during different menstrual cycle days (MCDs) were the main outcomes. RESULTS: A total of 120 enrolled women with hrHPV (mean [SD; range] age, 33.9 [6.9; 20.0 -52.0] years) provided 137 sanitary pads. The overall concordance rate of MB hrHPV capture sequencing and cervical HPV testing was 92.7% (95% CI, 88.3%-97.1%), with a kappa value of 0.763 (P < .001). Among 24 samples with incomplete concordance or discordant results, 11 samples with additional hrHPV genotypes (45.8%), 5 true-negative samples (20.8%), and the correct hrHPV genotypes of 2 samples (8.3%) were correctly identified by MB hrHPV capture sequencing. MB hrHPV detection of hrHPV was equivalent on different MCDs, with an MB hrHPV-positive rate of 27 of 28 patients (96.4%) for MCD 1, 52 of 57 patients (91.2%) for MCD 2, 27 of 28 patients for MCD 3, 4 of 4 patients (100%) for MCD 4, and 3 of 3 patients (100%) for MCD 5 (P = .76). The sensitivity of the MB hrHPV capture sequencing was 97.7% (95% CI, 95.0%-100%). CONCLUSIONS AND RELEVANCE: These findings suggest that MB hrHPV capture sequencing is a feasible and accurate self-collected approach for cervical cancer screening. This study found that this method is associated with superior performance in identification of HPV genotypes and true-negative events compared with cervical HPV testing. FAU - Zhang, Jingjing AU - Zhang J AD - Department of Obstetrics and Gynecology, First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China. FAU - Tian, Xun AU - Tian X AD - Department of Obstetrics and Gynecology, Academician Expert Workstation, Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. FAU - Chen, Ye AU - Chen Y AD - Department of Obstetrics and Gynecology, First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China. FAU - Huang, Sisi AU - Huang S AD - Medical Examination Center, Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. FAU - Cui, Zifeng AU - Cui Z AD - Department of Obstetrics and Gynecology, First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China. FAU - Tian, Rui AU - Tian R AD - Center for Translational Medicine, First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China. FAU - Zeng, Zhen AU - Zeng Z AD - Department of Obstetrics and Gynecology, Academician Expert Workstation, Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. FAU - Liang, Wenjia AU - Liang W AD - Department of Obstetrics and Gynecology, Academician Expert Workstation, Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. FAU - Gong, Qifen AU - Gong Q AD - Department of Obstetrics and Gynecology, Academician Expert Workstation, Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. AD - School of Medicine, Jianghan University, Wuhan, China. FAU - Shang, Ronghua AU - Shang R AD - Department of Obstetrics and Gynecology, Academician Expert Workstation, Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. AD - School of Medicine, Jianghan University, Wuhan, China. FAU - Hu, Zheng AU - Hu Z AD - Department of Obstetrics and Gynecology, First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China. AD - Sun Yat-sen University Nanchang Research Institute, Nanchang, China. FAU - Cao, Chen AU - Cao C AD - Department of Obstetrics and Gynecology, Academician Expert Workstation, Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20211201 PL - United States TA - JAMA Netw Open JT - JAMA network open JID - 101729235 SB - IM MH - Adult MH - Early Detection of Cancer/*methods MH - Feasibility Studies MH - Female MH - Humans MH - Menstruation/*blood MH - Papillomavirus Infections/*blood MH - Persistent Infection/*blood MH - Uterine Cervical Neoplasms/*virology PMC - PMC8703251 COIS- Conflict of Interest Disclosures: None reported. EDAT- 2021/12/24 06:00 MHDA- 2022/01/18 06:00 PMCR- 2021/12/23 CRDT- 2021/12/23 12:50 PHST- 2021/12/23 12:50 [entrez] PHST- 2021/12/24 06:00 [pubmed] PHST- 2022/01/18 06:00 [medline] PHST- 2021/12/23 00:00 [pmc-release] AID - 2787432 [pii] AID - zoi211141 [pii] AID - 10.1001/jamanetworkopen.2021.40644 [doi] PST - epublish SO - JAMA Netw Open. 2021 Dec 1;4(12):e2140644. doi: 10.1001/jamanetworkopen.2021.40644.