Diagnostic accuracy of human papillomavirus testing on self-collected samples among women referred for colposcopy
Abstract To assess the diagnostic accuracy of self-collected urine and vaginal samples for the identification of precancerous cervical lesions in the referral population using high-risk human papillomavirus (hrHPV) assays based on polymerase chain reaction (PCR). It was a prospective study carried o...
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Nature Portfolio
2025-01-01
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| Online Access: | https://doi.org/10.1038/s41598-025-86943-7 |
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| author | ChunX Yan Jiong Ma Xia Zheng Jing Shu XiaoJ Wang XiaoY Chen Feng Gao XiaoQ Li ShanQ M LongM Huang XiaoT Yu XueJ Chen |
| author_facet | ChunX Yan Jiong Ma Xia Zheng Jing Shu XiaoJ Wang XiaoY Chen Feng Gao XiaoQ Li ShanQ M LongM Huang XiaoT Yu XueJ Chen |
| author_sort | ChunX Yan |
| collection | DOAJ |
| description | Abstract To assess the diagnostic accuracy of self-collected urine and vaginal samples for the identification of precancerous cervical lesions in the referral population using high-risk human papillomavirus (hrHPV) assays based on polymerase chain reaction (PCR). It was a prospective study carried out in China from June 2021 to March 2022. The vaginal and urine samples were collected and analyzed by using a newly developed specific hrHPV PCR test, and matched cervical samples were analyzed by using an approved hrHPV DNA test. The primary outcomes were sensitivity for cervical intraepithelial neoplasia 2 or greater (CIN2 +). The secondary outcome was the accuracy of hrHPV findings in urine and vaginal samples compared to cervical samples. A total of 1,701 women were recruited with 113 women excluded. Among 1,588 qualified participants, a total of 203 cases of the CIN2 + group were enrolled in the two centers. The sensitivity and specificity of HPV detection for CIN2 + in urine, vaginal and cervical samples were 86.70% and 36.46%, 90.64% and 30.54%, 93.60% and 26.14%, respectively. The urine sample performed lower sensitivity (p = 0.003) and higher specificity (p < 0.001) than the cervical sample. There was no difference in sensitivity between vaginal and cervical samples (p = 0.146), and the specificity of vaginal samples was higher than that in cervical samples (p < 0.001). The agreement was 78.15% of urine and cervical samples and 85.71% of vaginal and cervical samples. HPV testing on self-collected urine and vaginal samples has acceptable consistency compared with traditional cervical samples. It may be an alternative option for cervical cancer screening. Additional studies are still required to substantiate this issue. |
| format | Article |
| id | doaj-art-90c650cf14a84027b9348230f5b80502 |
| institution | Kabale University |
| issn | 2045-2322 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Scientific Reports |
| spelling | doaj-art-90c650cf14a84027b9348230f5b805022025-01-26T12:30:05ZengNature PortfolioScientific Reports2045-23222025-01-011511610.1038/s41598-025-86943-7Diagnostic accuracy of human papillomavirus testing on self-collected samples among women referred for colposcopyChunX Yan0Jiong Ma1Xia Zheng2Jing Shu3XiaoJ Wang4XiaoY Chen5Feng Gao6XiaoQ Li7ShanQ M8LongM Huang9XiaoT Yu10XueJ Chen11The Second Affiliated Hospital Zhejiang University School of MedicineThe Second Affiliated Hospital Zhejiang University School of MedicineThe Second Affiliated Hospital Zhejiang University School of MedicineZhejiang Provincial People’s HospitalZhejiang Provincial People’s HospitalZhejiang Provincial People’s HospitalZhejiang Provincial People’s HospitalHangzhou New Horizon Health Technology Co., LtdHangzhou New Horizon Health Technology Co., LtdHangzhou New Horizon Health Technology Co., LtdHangzhou New Horizon Health Technology Co., LtdThe Second Affiliated Hospital Zhejiang University School of MedicineAbstract To assess the diagnostic accuracy of self-collected urine and vaginal samples for the identification of precancerous cervical lesions in the referral population using high-risk human papillomavirus (hrHPV) assays based on polymerase chain reaction (PCR). It was a prospective study carried out in China from June 2021 to March 2022. The vaginal and urine samples were collected and analyzed by using a newly developed specific hrHPV PCR test, and matched cervical samples were analyzed by using an approved hrHPV DNA test. The primary outcomes were sensitivity for cervical intraepithelial neoplasia 2 or greater (CIN2 +). The secondary outcome was the accuracy of hrHPV findings in urine and vaginal samples compared to cervical samples. A total of 1,701 women were recruited with 113 women excluded. Among 1,588 qualified participants, a total of 203 cases of the CIN2 + group were enrolled in the two centers. The sensitivity and specificity of HPV detection for CIN2 + in urine, vaginal and cervical samples were 86.70% and 36.46%, 90.64% and 30.54%, 93.60% and 26.14%, respectively. The urine sample performed lower sensitivity (p = 0.003) and higher specificity (p < 0.001) than the cervical sample. There was no difference in sensitivity between vaginal and cervical samples (p = 0.146), and the specificity of vaginal samples was higher than that in cervical samples (p < 0.001). The agreement was 78.15% of urine and cervical samples and 85.71% of vaginal and cervical samples. HPV testing on self-collected urine and vaginal samples has acceptable consistency compared with traditional cervical samples. It may be an alternative option for cervical cancer screening. Additional studies are still required to substantiate this issue.https://doi.org/10.1038/s41598-025-86943-7HPV testingCervical intraepithelial neoplasiaDiagnostic test accuracyHuman papillomavirusUrineSelf-sampling |
| spellingShingle | ChunX Yan Jiong Ma Xia Zheng Jing Shu XiaoJ Wang XiaoY Chen Feng Gao XiaoQ Li ShanQ M LongM Huang XiaoT Yu XueJ Chen Diagnostic accuracy of human papillomavirus testing on self-collected samples among women referred for colposcopy Scientific Reports HPV testing Cervical intraepithelial neoplasia Diagnostic test accuracy Human papillomavirus Urine Self-sampling |
| title | Diagnostic accuracy of human papillomavirus testing on self-collected samples among women referred for colposcopy |
| title_full | Diagnostic accuracy of human papillomavirus testing on self-collected samples among women referred for colposcopy |
| title_fullStr | Diagnostic accuracy of human papillomavirus testing on self-collected samples among women referred for colposcopy |
| title_full_unstemmed | Diagnostic accuracy of human papillomavirus testing on self-collected samples among women referred for colposcopy |
| title_short | Diagnostic accuracy of human papillomavirus testing on self-collected samples among women referred for colposcopy |
| title_sort | diagnostic accuracy of human papillomavirus testing on self collected samples among women referred for colposcopy |
| topic | HPV testing Cervical intraepithelial neoplasia Diagnostic test accuracy Human papillomavirus Urine Self-sampling |
| url | https://doi.org/10.1038/s41598-025-86943-7 |
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