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Clinical performance of the HPV-Risk assay on cervical samples in SurePath medium using the VALGENT-4 panel

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@article{b510154021944f5a91b472f71d8de874,
title = "Clinical performance of the HPV-Risk assay on cervical samples in SurePath medium using the VALGENT-4 panel",
abstract = "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; p McN=1.000, and for CIN2+1.01; 95{\%}CI: 0.96-1.06; p McN=1.000) at significantly higher specificity (relative specificity 1.04; 95{\%}CI: 1.02-1.06; p McN<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.",
keywords = "Cervical cancer screening, Clinical validation, HPV-risk assay, Human papillomavirus, Liquid medium, Test accuracy",
author = "Heideman, {D A M} and L Xu and Hesselink, {A T} and S Doorn and Ejegod, {D M} and H Pedersen and Quint, {W G V} and J Bonde and M Arbyn",
note = "Copyright {\circledC} 2019 The Author(s). Published by Elsevier B.V. All rights reserved.",
year = "2019",
month = "12",
doi = "10.1016/j.jcv.2019.104201",
language = "English",
volume = "121",
journal = "Journal of Clinical Virology",
issn = "1386-6532",
publisher = "Elsevier BV",

}

RIS

TY - JOUR

T1 - Clinical performance of the HPV-Risk assay on cervical samples in SurePath medium using the VALGENT-4 panel

AU - Heideman, D A M

AU - Xu, L

AU - Hesselink, A T

AU - Doorn, S

AU - Ejegod, D M

AU - Pedersen, H

AU - Quint, W G V

AU - Bonde, J

AU - Arbyn, M

N1 - Copyright © 2019 The Author(s). Published by Elsevier B.V. All rights reserved.

PY - 2019/12

Y1 - 2019/12

N2 - 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; p McN=1.000, and for CIN2+1.01; 95%CI: 0.96-1.06; p McN=1.000) at significantly higher specificity (relative specificity 1.04; 95%CI: 1.02-1.06; p McN<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.

AB - 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; p McN=1.000, and for CIN2+1.01; 95%CI: 0.96-1.06; p McN=1.000) at significantly higher specificity (relative specificity 1.04; 95%CI: 1.02-1.06; p McN<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.

KW - Cervical cancer screening

KW - Clinical validation

KW - HPV-risk assay

KW - Human papillomavirus

KW - Liquid medium

KW - Test accuracy

UR - http://www.scopus.com/inward/record.url?scp=85073218706&partnerID=8YFLogxK

U2 - 10.1016/j.jcv.2019.104201

DO - 10.1016/j.jcv.2019.104201

M3 - Journal article

VL - 121

JO - Journal of Clinical Virology

JF - Journal of Clinical Virology

SN - 1386-6532

M1 - 104201

ER -

ID: 58181141