Comparison of cycle threshold values of the Cobas HPV test and viral loads of the BMRT HPV test in cervical cancer screening
ObjectiveTo validate the HPV viral loads that are reflected by the cycle threshold values of Cobas4800 as the viral load indicators by verifying the consistency of the viral loads per unit (10,000 cells) from the BMRT assay.MethodsThe analysis is based on data from the Chinese Multi-Center Screening...
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Frontiers Media S.A.
2022-11-01
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpubh.2022.1010066/full |
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| author | Qing Yang Qing Yang Qing Yang Hui Du Hui Du Hui Du Xinfeng Qu Xinfeng Qu Wenkui Dai Wenkui Dai Wenkui Dai Liming Gui Liming Gui Liming Gui Changzhong Li Changzhong Li Changzhong Li Chun Wang Chun Wang Chun Wang Chunlei Guo Chunlei Guo Chunlei Guo Yi Zhang Yi Zhang Yi Zhang Lihui Wei J. L. Belinson Ruifang Wu Ruifang Wu Ruifang Wu |
| author_facet | Qing Yang Qing Yang Qing Yang Hui Du Hui Du Hui Du Xinfeng Qu Xinfeng Qu Wenkui Dai Wenkui Dai Wenkui Dai Liming Gui Liming Gui Liming Gui Changzhong Li Changzhong Li Changzhong Li Chun Wang Chun Wang Chun Wang Chunlei Guo Chunlei Guo Chunlei Guo Yi Zhang Yi Zhang Yi Zhang Lihui Wei J. L. Belinson Ruifang Wu Ruifang Wu Ruifang Wu |
| author_sort | Qing Yang |
| collection | DOAJ |
| description | ObjectiveTo validate the HPV viral loads that are reflected by the cycle threshold values of Cobas4800 as the viral load indicators by verifying the consistency of the viral loads per unit (10,000 cells) from the BMRT assay.MethodsThe analysis is based on data from the Chinese Multi-Center Screening Trial (CHIMUST). The cases included in the analysis are all positive for physician-collected hrHPV on SeqHPV and/or Cobas4800 or negative for hrHPV but abnormal in cytology (≥LSIL), and some cases selected by nested case-control randomization from those negative for physician-collected hrHPV and cytology. With HPV testing results and relevant Ct values from Cobas4800 available, we tested the entire sample set with the BMRT HPV testing assay and analyzed their agreement with Cobas4800, followed by a comparison of the CtV from Cobas4800 and viral loads (lg) from BMRT by lesion grade.ResultsWe included 4,485 women (mean age: 45.4 years) in the study, and 4,290 had complete data. The consistency of genotypes from Cobas4800 and BMRT for hrHPV, HPV-16, HPV-18, and 12-HPV pools was 94.9% (4070/4290, Kappa = 0.827), 99.1% (4251/4290, Kappa = 0.842), 99.6% (4,273/4,290, Kappa = 0.777), and 95.3% (4,089/4,290, Kappa = 0.821), respectively. Further analysis shows that any inconsistency between the two assays is likely among samples with comparatively lower viral loads. When analyzing per lesions of CIN2+ and CIN3+, the CtV from Cobas4800 and VL (lg) from BMRT are highly correlated inversely and follow the linear regression for HPV16 and 12-HPV pool (Pearson's or Spearman's correlation coefficient (r): In CIN3+, r HPV16 = −0.641, P < 0.001; r 12−HPVpool = −0.343, P = 0.109; In CIN2+, r HPV16 = −0.754, P < 0.001; r 12−HPVpool = −0.429, P < 0.001).ConclusionThe CtV from Cobas4800 and the viral loads (lg) of per unit cells from the BMRT are well correlated for lesion grading when tested on physician-collected samples. Cobas-CtV is worthy of further study for clinical application. |
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| last_indexed | 2024-04-11T17:33:57Z |
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| spelling | doaj.art-f07bae8012a6475480e5fcb19753cdd32022-12-22T04:11:56ZengFrontiers Media S.A.Frontiers in Public Health2296-25652022-11-011010.3389/fpubh.2022.10100661010066Comparison of cycle threshold values of the Cobas HPV test and viral loads of the BMRT HPV test in cervical cancer screeningQing Yang0Qing Yang1Qing Yang2Hui Du3Hui Du4Hui Du5Xinfeng Qu6Xinfeng Qu7Wenkui Dai8Wenkui Dai9Wenkui Dai10Liming Gui11Liming Gui12Liming Gui13Changzhong Li14Changzhong Li15Changzhong Li16Chun Wang17Chun Wang18Chun Wang19Chunlei Guo20Chunlei Guo21Chunlei Guo22Yi Zhang23Yi Zhang24Yi Zhang25Lihui Wei26J. L. Belinson27Ruifang Wu28Ruifang Wu29Ruifang Wu30Department of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, ChinaInstitute of Obstetrics and Gynecology, Peking University–Hong Kong University of Science and Technology (PKU-HKUST) Medical Center, Shenzhen, ChinaShenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecologic Diseases, Peking University Shenzhen Hospital, Shenzhen, ChinaDepartment of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, ChinaInstitute of Obstetrics and Gynecology, Peking University–Hong Kong University of Science and Technology (PKU-HKUST) Medical Center, Shenzhen, ChinaShenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecologic Diseases, Peking University Shenzhen Hospital, Shenzhen, ChinaDepartment of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, ChinaInstitute of Obstetrics and Gynecology, Peking University–Hong Kong University of Science and Technology (PKU-HKUST) Medical Center, Shenzhen, ChinaDepartment of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, ChinaInstitute of Obstetrics and Gynecology, Peking University–Hong Kong University of Science and Technology (PKU-HKUST) Medical Center, Shenzhen, ChinaShenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecologic Diseases, Peking University Shenzhen Hospital, Shenzhen, ChinaDepartment of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, ChinaInstitute of Obstetrics and Gynecology, Peking University–Hong Kong University of Science and Technology (PKU-HKUST) Medical Center, Shenzhen, ChinaShenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecologic Diseases, Peking University Shenzhen Hospital, Shenzhen, ChinaDepartment of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, ChinaInstitute of Obstetrics and Gynecology, Peking University–Hong Kong University of Science and Technology (PKU-HKUST) Medical Center, Shenzhen, ChinaShenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecologic Diseases, Peking University Shenzhen Hospital, Shenzhen, ChinaDepartment of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, ChinaInstitute of Obstetrics and Gynecology, Peking University–Hong Kong University of Science and Technology (PKU-HKUST) Medical Center, Shenzhen, ChinaShenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecologic Diseases, Peking University Shenzhen Hospital, Shenzhen, ChinaDepartment of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, ChinaInstitute of Obstetrics and Gynecology, Peking University–Hong Kong University of Science and Technology (PKU-HKUST) Medical Center, Shenzhen, ChinaShenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecologic Diseases, Peking University Shenzhen Hospital, Shenzhen, ChinaDepartment of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, ChinaInstitute of Obstetrics and Gynecology, Peking University–Hong Kong University of Science and Technology (PKU-HKUST) Medical Center, Shenzhen, ChinaShenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecologic Diseases, Peking University Shenzhen Hospital, Shenzhen, ChinaDepartment of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, ChinaPreventive Oncology International, Inc., The Women's Health Institute, Cleveland Clinic, Cleveland, OH, United StatesDepartment of Obstetrics and Gynecology, Peking University Shenzhen Hospital, Shenzhen, ChinaInstitute of Obstetrics and Gynecology, Peking University–Hong Kong University of Science and Technology (PKU-HKUST) Medical Center, Shenzhen, ChinaShenzhen Key Laboratory on Technology for Early Diagnosis of Major Gynecologic Diseases, Peking University Shenzhen Hospital, Shenzhen, ChinaObjectiveTo validate the HPV viral loads that are reflected by the cycle threshold values of Cobas4800 as the viral load indicators by verifying the consistency of the viral loads per unit (10,000 cells) from the BMRT assay.MethodsThe analysis is based on data from the Chinese Multi-Center Screening Trial (CHIMUST). The cases included in the analysis are all positive for physician-collected hrHPV on SeqHPV and/or Cobas4800 or negative for hrHPV but abnormal in cytology (≥LSIL), and some cases selected by nested case-control randomization from those negative for physician-collected hrHPV and cytology. With HPV testing results and relevant Ct values from Cobas4800 available, we tested the entire sample set with the BMRT HPV testing assay and analyzed their agreement with Cobas4800, followed by a comparison of the CtV from Cobas4800 and viral loads (lg) from BMRT by lesion grade.ResultsWe included 4,485 women (mean age: 45.4 years) in the study, and 4,290 had complete data. The consistency of genotypes from Cobas4800 and BMRT for hrHPV, HPV-16, HPV-18, and 12-HPV pools was 94.9% (4070/4290, Kappa = 0.827), 99.1% (4251/4290, Kappa = 0.842), 99.6% (4,273/4,290, Kappa = 0.777), and 95.3% (4,089/4,290, Kappa = 0.821), respectively. Further analysis shows that any inconsistency between the two assays is likely among samples with comparatively lower viral loads. When analyzing per lesions of CIN2+ and CIN3+, the CtV from Cobas4800 and VL (lg) from BMRT are highly correlated inversely and follow the linear regression for HPV16 and 12-HPV pool (Pearson's or Spearman's correlation coefficient (r): In CIN3+, r HPV16 = −0.641, P < 0.001; r 12−HPVpool = −0.343, P = 0.109; In CIN2+, r HPV16 = −0.754, P < 0.001; r 12−HPVpool = −0.429, P < 0.001).ConclusionThe CtV from Cobas4800 and the viral loads (lg) of per unit cells from the BMRT are well correlated for lesion grading when tested on physician-collected samples. Cobas-CtV is worthy of further study for clinical application.https://www.frontiersin.org/articles/10.3389/fpubh.2022.1010066/fullhuman papillomaviruscervical cancerCobas4800 assayBMRT assayviral loads |
| spellingShingle | Qing Yang Qing Yang Qing Yang Hui Du Hui Du Hui Du Xinfeng Qu Xinfeng Qu Wenkui Dai Wenkui Dai Wenkui Dai Liming Gui Liming Gui Liming Gui Changzhong Li Changzhong Li Changzhong Li Chun Wang Chun Wang Chun Wang Chunlei Guo Chunlei Guo Chunlei Guo Yi Zhang Yi Zhang Yi Zhang Lihui Wei J. L. Belinson Ruifang Wu Ruifang Wu Ruifang Wu Comparison of cycle threshold values of the Cobas HPV test and viral loads of the BMRT HPV test in cervical cancer screening Frontiers in Public Health human papillomavirus cervical cancer Cobas4800 assay BMRT assay viral loads |
| title | Comparison of cycle threshold values of the Cobas HPV test and viral loads of the BMRT HPV test in cervical cancer screening |
| title_full | Comparison of cycle threshold values of the Cobas HPV test and viral loads of the BMRT HPV test in cervical cancer screening |
| title_fullStr | Comparison of cycle threshold values of the Cobas HPV test and viral loads of the BMRT HPV test in cervical cancer screening |
| title_full_unstemmed | Comparison of cycle threshold values of the Cobas HPV test and viral loads of the BMRT HPV test in cervical cancer screening |
| title_short | Comparison of cycle threshold values of the Cobas HPV test and viral loads of the BMRT HPV test in cervical cancer screening |
| title_sort | comparison of cycle threshold values of the cobas hpv test and viral loads of the bmrt hpv test in cervical cancer screening |
| topic | human papillomavirus cervical cancer Cobas4800 assay BMRT assay viral loads |
| url | https://www.frontiersin.org/articles/10.3389/fpubh.2022.1010066/full |
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