Clinical performance of the HPV-Risk assay on cervical samples in SurePath medium using the VALGENT-4 panel
Copyright © 2019 The Author(s). Published by Elsevier B.V. All rights reserved..
BACKGROUND: The VALidation of HPV GENoyping Tests (VALGENT) framework is designed for comparison and clinical validation of HPV assays.
OBJECTIVES: To evaluate the accuracy of the HPV-Risk assay within VALGENT-4, relative to clinically validated comparator HPV tests.
STUDY DESIGN: The VALGENT-4 panel comprises consecutive SurePath cervical samples from routine screening (n=998), of which 51 had abnormal cytology and 13 women had cervical intraepithelial neoplasia (CIN) grade 2 or worse (CIN2+), enriched with SurePath cervical samples from 297 women with abnormal cytology and 109 CIN2+. HPV-Risk assay was performed on DNA extracted panel samples (n=1,295), blinded to clinical data, cytology results, and results from other HPV assays evaluated in VALGENT-4. All assay results were reported to the central VALGENT coordination institute for data and statistical analysis. HPV prevalence was analysed and accuracy for detection of CIN grade 3 or worse (CIN3+) and CIN2+ were assessed relative to GP5+/6+-PCR-EIA and GP5+/6+-PCR-EIA-LMNX.
RESULTS: The sensitivity of the HPV-Risk assay for detection of CIN3+ and CIN2+ was similar to that of GP5+/6+-PCR-EIA (relative sensitivity for CIN3+1.01; 95%CI: 0.97-1.06; pMcN=1.000, and for CIN2+1.01; 95%CI: 0.96-1.06; pMcN=1.000) at significantly higher specificity (relative specificity 1.04; 95%CI: 1.02-1.06; pMcN<0.001). The accuracy of the HPV-Risk assay for CIN3+ and CIN2+ was non-inferior compared to GP5+/6+-PCR- EIA and GP5+/6+-PCR-EIA-LMNX, with all p-values ≤0.002. HPV16/18 genotype agreement between HPV-Risk assay and GP5+/6+-PCR-LMNX was high.
CONCLUSIONS: The HPV-Risk assay demonstrated non-inferiority to clinically validated comparator assays on cervical samples in SurePath medium using the VALGENT-4 panel, and is therefore suitable for cervical cancer screening.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:121 |
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| Enthalten in: |
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology - 121(2019) vom: 15. Dez., Seite 104201 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Heideman, D A M [VerfasserIn] |
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| Links: |
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| Themen: |
Cervical cancer screening |
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| Anmerkungen: |
Date Completed 23.07.2020 Date Revised 07.12.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jcv.2019.104201 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM302362665 |
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| 245 | 1 | 0 | |a Clinical performance of the HPV-Risk assay on cervical samples in SurePath medium using the VALGENT-4 panel |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2019 The Author(s). Published by Elsevier B.V. All rights reserved. | ||
| 520 | |a BACKGROUND: The VALidation of HPV GENoyping Tests (VALGENT) framework is designed for comparison and clinical validation of HPV assays | ||
| 520 | |a OBJECTIVES: To evaluate the accuracy of the HPV-Risk assay within VALGENT-4, relative to clinically validated comparator HPV tests | ||
| 520 | |a STUDY DESIGN: The VALGENT-4 panel comprises consecutive SurePath cervical samples from routine screening (n=998), of which 51 had abnormal cytology and 13 women had cervical intraepithelial neoplasia (CIN) grade 2 or worse (CIN2+), enriched with SurePath cervical samples from 297 women with abnormal cytology and 109 CIN2+. HPV-Risk assay was performed on DNA extracted panel samples (n=1,295), blinded to clinical data, cytology results, and results from other HPV assays evaluated in VALGENT-4. All assay results were reported to the central VALGENT coordination institute for data and statistical analysis. HPV prevalence was analysed and accuracy for detection of CIN grade 3 or worse (CIN3+) and CIN2+ were assessed relative to GP5+/6+-PCR-EIA and GP5+/6+-PCR-EIA-LMNX | ||
| 520 | |a RESULTS: The sensitivity of the HPV-Risk assay for detection of CIN3+ and CIN2+ was similar to that of GP5+/6+-PCR-EIA (relative sensitivity for CIN3+1.01; 95%CI: 0.97-1.06; pMcN=1.000, and for CIN2+1.01; 95%CI: 0.96-1.06; pMcN=1.000) at significantly higher specificity (relative specificity 1.04; 95%CI: 1.02-1.06; pMcN<0.001). The accuracy of the HPV-Risk assay for CIN3+ and CIN2+ was non-inferior compared to GP5+/6+-PCR- EIA and GP5+/6+-PCR-EIA-LMNX, with all p-values ≤0.002. HPV16/18 genotype agreement between HPV-Risk assay and GP5+/6+-PCR-LMNX was high | ||
| 520 | |a CONCLUSIONS: The HPV-Risk assay demonstrated non-inferiority to clinically validated comparator assays on cervical samples in SurePath medium using the VALGENT-4 panel, and is therefore suitable for cervical cancer screening | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Cervical cancer screening | |
| 650 | 4 | |a Clinical validation | |
| 650 | 4 | |a HPV-risk assay | |
| 650 | 4 | |a Human papillomavirus | |
| 650 | 4 | |a Liquid medium | |
| 650 | 4 | |a Test accuracy | |
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| 700 | 1 | |a Hesselink, A T |e verfasserin |4 aut | |
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| 700 | 1 | |a Ejegod, D M |e verfasserin |4 aut | |
| 700 | 1 | |a Pedersen, H |e verfasserin |4 aut | |
| 700 | 1 | |a Quint, W G V |e verfasserin |4 aut | |
| 700 | 1 | |a Bonde, J |e verfasserin |4 aut | |
| 700 | 1 | |a Arbyn, M |e verfasserin |4 aut | |
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