Diagnostic accuracy of extended HPV DNA genotyping and its application for risk-based cervical cancer screening strategy
© 2023 the author(s), published by De Gruyter, Berlin/Boston..
OBJECTIVES: To evaluate the consistency of 14 high-risk HPVs (hr-HPVs) detection between extended HPV DNA genotyping and a well-validated partial HPV genotyping kit, and to explore the diagnostic accuracy of risk stratification strategy based on extended HPV genotyping for cervical cancer (CC) screening.
METHODS: Baseline data from a clinical trial of recombinant HPV 9-valent vaccine in China was analyzed. All enrolled women aged 20-45 years received cervical cytology, HPV detection by extended and partial HPV genotyping kits. Those who met the indications would further receive colposcopy. The primary endpoints were cervical intraepithelial neoplasia 2/3 or worse (CIN2+/CIN3+).
RESULTS: A total of 8,000 women were enrolled between April 2020 and July 2020 and 83/33 cases were diagnosed as CIN2+/CIN3+. The overall agreement between the extended and partial HPV genotyping was 92.66 %. And the agreement further increased with the progression of lesions, which lead to similarly high sensitivity and negative predictive value of these kits. A stratified triage strategy of CC screening was constructed based on the immediate CIN2+/CIN3+ risk of specific HPV. Compared with the conventional HPV primary CC screening strategy, the risk-based strategy had higher specificity for CIN (CIN2+: 94.84 vs. 92.46 %, CIN3+: 96.05 vs. 91.92 %), and needed fewer colposcopies for detecting one cervical disease.
CONCLUSIONS: Extended HPV genotyping had good agreement with a well-validated partial HPV genotyping CC primary screening kit in hr-HPV detection. Extended HPV genotyping could facilitate risk-based stratified management strategy and improve the diagnostic accuracy of primary CC screening.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:61 |
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| Enthalten in: |
Clinical chemistry and laboratory medicine - 61(2023), 12 vom: 27. Nov., Seite 2229-2236 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Xie, Hongyu [VerfasserIn] |
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| Links: |
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| Themen: |
Cervical cancer screening |
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| Anmerkungen: |
Date Completed 27.10.2023 Date Revised 27.10.2023 published: Electronic-Print Citation Status MEDLINE |
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| doi: |
10.1515/cclm-2023-0440 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM359425208 |
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| 245 | 1 | 0 | |a Diagnostic accuracy of extended HPV DNA genotyping and its application for risk-based cervical cancer screening strategy |
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| 500 | |a published: Electronic-Print | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 the author(s), published by De Gruyter, Berlin/Boston. | ||
| 520 | |a OBJECTIVES: To evaluate the consistency of 14 high-risk HPVs (hr-HPVs) detection between extended HPV DNA genotyping and a well-validated partial HPV genotyping kit, and to explore the diagnostic accuracy of risk stratification strategy based on extended HPV genotyping for cervical cancer (CC) screening | ||
| 520 | |a METHODS: Baseline data from a clinical trial of recombinant HPV 9-valent vaccine in China was analyzed. All enrolled women aged 20-45 years received cervical cytology, HPV detection by extended and partial HPV genotyping kits. Those who met the indications would further receive colposcopy. The primary endpoints were cervical intraepithelial neoplasia 2/3 or worse (CIN2+/CIN3+) | ||
| 520 | |a RESULTS: A total of 8,000 women were enrolled between April 2020 and July 2020 and 83/33 cases were diagnosed as CIN2+/CIN3+. The overall agreement between the extended and partial HPV genotyping was 92.66 %. And the agreement further increased with the progression of lesions, which lead to similarly high sensitivity and negative predictive value of these kits. A stratified triage strategy of CC screening was constructed based on the immediate CIN2+/CIN3+ risk of specific HPV. Compared with the conventional HPV primary CC screening strategy, the risk-based strategy had higher specificity for CIN (CIN2+: 94.84 vs. 92.46 %, CIN3+: 96.05 vs. 91.92 %), and needed fewer colposcopies for detecting one cervical disease | ||
| 520 | |a CONCLUSIONS: Extended HPV genotyping had good agreement with a well-validated partial HPV genotyping CC primary screening kit in hr-HPV detection. Extended HPV genotyping could facilitate risk-based stratified management strategy and improve the diagnostic accuracy of primary CC screening | ||
| 650 | 4 | |a Clinical Trial | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a cervical cancer screening | |
| 650 | 4 | |a cervical intraepithelial neoplasia | |
| 650 | 4 | |a extended HPV genotyping | |
| 650 | 4 | |a risk-based stratified management strategy | |
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| 700 | 1 | |a Li, Junyan |e verfasserin |4 aut | |
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| 700 | 1 | |a Ji, Ying |e verfasserin |4 aut | |
| 700 | 1 | |a Zhang, Juan |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Hui |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Xinyu |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Xiao |e verfasserin |4 aut | |
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