The Risk Stratification for Cervical Cancer and Precursors of Domestic HPV Testing With HPV 16/18 Genotyping in Women With NILM Cytology in CentralChina : A Cohort Study
Copyright © 2021 Xu, Liu, Luo, Zhao, Jia, Chen, Li, Sun, Liu, Sun and Zhang..
OBJECTIVE: To evaluate the clinical performance and utility for risk stratification of DH3 HPV assay in women (≥30 years) with NILM cytology.
METHODS: A prospective cohort was established in Central China between November 8 to December 14, 2016 which consisted of 2180 women aging 30-64 years with NILM cytology. At baseline, all women were screened using DH3 HPV assay. HPV 16/18 positive women would be assigned to colposcopy and biopsied if necessary. Then, hr-HPV positive women without CIN2+ lesions would be followed up by cytology every 12 months for two years. In the 3rd year of follow up, all women that were not biopsy proven CIN2+ would be called back and screened by cytology again. In follow-up period, women with ASC-US and above were referred to colposcopy and biopsied if clinically indicated. CIN2+ was the primary endpoint in analysis. The clinical performance and utility for risk stratification of DH3 HPV assay were assessed by SPSS 22.0 and SAS 9.4.
RESULTS: Of 2180 qualified women, the prevalence of hr-HPV was 8.5% (185/2180), 45(2.1%) were HPV 16/18 positive. The clinical performance for HPV16/18 was 91.7% for sensitivity, 98.4% for specificity, respectively against CIN2+ detection at baseline. In four years of study, the corresponding rates of HPV 16/18 were 51.5% and 98.7%, respectively. The cumulative absolute risk for the development of CIN2+ was as high as 37.8% for HPV 16/18 positive women, followed by hr-HPV positive (14.6%), other hr-HPV positive (11.0%) and HPV negative (0.3%) in three years. The relative risk was 125.6 and 3.4 for HPV 16/18 positive group when compared with HPV negative and other hr-HPV positive group, respectively.
CONCLUSIONS: DH3 HPV assay demonstrated excellent clinical performance against CIN2+ detection in cervical cancer screening and utility of risk stratification by genotyping to promote scientific management of women with NILM cytology.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2021 |
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| Erschienen: |
2021 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:11 |
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| Enthalten in: |
Frontiers in oncology - 11(2021) vom: 02., Seite 716762 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Xu, Hui-Fang [VerfasserIn] |
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| Links: |
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| Themen: |
Cervical cancer |
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| Anmerkungen: |
Date Revised 27.04.2022 published: Electronic-eCollection Citation Status PubMed-not-MEDLINE |
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| doi: |
10.3389/fonc.2021.716762 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Xu, Hui-Fang |e verfasserin |4 aut | |
| 245 | 1 | 4 | |a The Risk Stratification for Cervical Cancer and Precursors of Domestic HPV Testing With HPV 16/18 Genotyping in Women With NILM Cytology in CentralChina |b A Cohort Study |
| 264 | 1 | |c 2021 | |
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| 500 | |a Citation Status PubMed-not-MEDLINE | ||
| 520 | |a Copyright © 2021 Xu, Liu, Luo, Zhao, Jia, Chen, Li, Sun, Liu, Sun and Zhang. | ||
| 520 | |a OBJECTIVE: To evaluate the clinical performance and utility for risk stratification of DH3 HPV assay in women (≥30 years) with NILM cytology | ||
| 520 | |a METHODS: A prospective cohort was established in Central China between November 8 to December 14, 2016 which consisted of 2180 women aging 30-64 years with NILM cytology. At baseline, all women were screened using DH3 HPV assay. HPV 16/18 positive women would be assigned to colposcopy and biopsied if necessary. Then, hr-HPV positive women without CIN2+ lesions would be followed up by cytology every 12 months for two years. In the 3rd year of follow up, all women that were not biopsy proven CIN2+ would be called back and screened by cytology again. In follow-up period, women with ASC-US and above were referred to colposcopy and biopsied if clinically indicated. CIN2+ was the primary endpoint in analysis. The clinical performance and utility for risk stratification of DH3 HPV assay were assessed by SPSS 22.0 and SAS 9.4 | ||
| 520 | |a RESULTS: Of 2180 qualified women, the prevalence of hr-HPV was 8.5% (185/2180), 45(2.1%) were HPV 16/18 positive. The clinical performance for HPV16/18 was 91.7% for sensitivity, 98.4% for specificity, respectively against CIN2+ detection at baseline. In four years of study, the corresponding rates of HPV 16/18 were 51.5% and 98.7%, respectively. The cumulative absolute risk for the development of CIN2+ was as high as 37.8% for HPV 16/18 positive women, followed by hr-HPV positive (14.6%), other hr-HPV positive (11.0%) and HPV negative (0.3%) in three years. The relative risk was 125.6 and 3.4 for HPV 16/18 positive group when compared with HPV negative and other hr-HPV positive group, respectively | ||
| 520 | |a CONCLUSIONS: DH3 HPV assay demonstrated excellent clinical performance against CIN2+ detection in cervical cancer screening and utility of risk stratification by genotyping to promote scientific management of women with NILM cytology | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a HPV genotyping | |
| 650 | 4 | |a cervical cancer | |
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| 700 | 1 | |a Luo, Yan-Lin |e verfasserin |4 aut | |
| 700 | 1 | |a Zhao, Dong-Mei |e verfasserin |4 aut | |
| 700 | 1 | |a Jia, Man-Man |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Pei-Pei |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Meng-Jie |e verfasserin |4 aut | |
| 700 | 1 | |a Sun, Xing-Ai |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Shu-Zheng |e verfasserin |4 aut | |
| 700 | 1 | |a Sun, Xi-Bin |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Shao-Kai |e verfasserin |4 aut | |
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