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Evaluation of HarmoniaHPV test for detection of clinically significant Human Papillomavirus infection using the VALGENT framework

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Bhatia, Ramya ; Boada, Elia Alcañiz ; Bonde, Jesper ; Quint, Wim ; Christiansen, Irene Kraus ; Xu, Lan ; Ejegod, Ditte Møller ; Moncur, Sharon ; Cuschieri, Kate ; Arbyn, Marc. / Evaluation of HarmoniaHPV test for detection of clinically significant Human Papillomavirus infection using the VALGENT framework. I: Journal of Virological Methods. 2021 ; Bind 294.

Bibtex

@article{bc963251caaf4a37bc20507915a6d6cb,
title = "Evaluation of HarmoniaHPV test for detection of clinically significant Human Papillomavirus infection using the VALGENT framework",
abstract = "Aim: The VALidation of HPV GENotyping Tests (VALGENT) is a framework for comparison and validation of HPV tests with genotyping capabilities. In this study, the clinical performance of a single tube HPV test -HarmoniaHPV- was assessed in SurePath{\texttrademark} samples and compared to a clinically validated reference test, the GP5+/6+ Enzyme ImmunoAssay (GP5+/6 + EIA). Methods: HarmoniaHPV test is a real-time, PCR based, limited genotyping HPV test which detects 14 high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 with HPV16, and HPV 18 reported individually. Clinical performance was assessed using 998 unselected, cervical screening samples enriched with 297 cytologically abnormal specimens (100 atypical squamous cells of unspecified significance, 100 low-grade squamous intraepithelial lesions, 97 high-grade squamous intraepithelial lesions). Cases were defined as women diagnosed with histologically confirmed cervical intraepithelial neoplasia 2 or more (≥CIN2, N = 122). Results: Using the manufacturer recommended (un-adjusted) cut-offs, HarmoniaHPV had non-inferior sensitivity for detection of ≥ CIN2 but showed inferior specificity. A cut-off optimisation exercise was therefore carried out and optimised cut-offs for each individual channel rendered a sensitivity and specificity of HarmoniaHPV that was non-inferior to GP5+/6 + EIA. Analytically, the test showed excellent intra- and inter-laboratory reproducibility, which improved further with the use of the optimised cut-offs. Conclusion: HarmoniaHPV when operated with optimised cut-offs fulfils the international clinical criteria for use in cervical cancer screening on SurePath samples. The optimised cut-offs warrant additional testing and independent validation.",
keywords = "HarmoniaHPV, HPV screening, HRHPV, Valgent",
author = "Ramya Bhatia and Boada, {Elia Alca{\~n}iz} and Jesper Bonde and Wim Quint and Christiansen, {Irene Kraus} and Lan Xu and Ejegod, {Ditte M{\o}ller} and Sharon Moncur and Kate Cuschieri and Marc Arbyn",
note = "Crown Copyright {\textcopyright} 2021. Published by Elsevier B.V. All rights reserved.",
year = "2021",
month = aug,
doi = "10.1016/j.jviromet.2021.114161",
language = "English",
volume = "294",
journal = "Journal of Virological Methods",
issn = "0166-0934",
publisher = "Elsevier",

}

RIS

TY - JOUR

T1 - Evaluation of HarmoniaHPV test for detection of clinically significant Human Papillomavirus infection using the VALGENT framework

AU - Bhatia, Ramya

AU - Boada, Elia Alcañiz

AU - Bonde, Jesper

AU - Quint, Wim

AU - Christiansen, Irene Kraus

AU - Xu, Lan

AU - Ejegod, Ditte Møller

AU - Moncur, Sharon

AU - Cuschieri, Kate

AU - Arbyn, Marc

N1 - Crown Copyright © 2021. Published by Elsevier B.V. All rights reserved.

PY - 2021/8

Y1 - 2021/8

N2 - Aim: The VALidation of HPV GENotyping Tests (VALGENT) is a framework for comparison and validation of HPV tests with genotyping capabilities. In this study, the clinical performance of a single tube HPV test -HarmoniaHPV- was assessed in SurePath™ samples and compared to a clinically validated reference test, the GP5+/6+ Enzyme ImmunoAssay (GP5+/6 + EIA). Methods: HarmoniaHPV test is a real-time, PCR based, limited genotyping HPV test which detects 14 high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 with HPV16, and HPV 18 reported individually. Clinical performance was assessed using 998 unselected, cervical screening samples enriched with 297 cytologically abnormal specimens (100 atypical squamous cells of unspecified significance, 100 low-grade squamous intraepithelial lesions, 97 high-grade squamous intraepithelial lesions). Cases were defined as women diagnosed with histologically confirmed cervical intraepithelial neoplasia 2 or more (≥CIN2, N = 122). Results: Using the manufacturer recommended (un-adjusted) cut-offs, HarmoniaHPV had non-inferior sensitivity for detection of ≥ CIN2 but showed inferior specificity. A cut-off optimisation exercise was therefore carried out and optimised cut-offs for each individual channel rendered a sensitivity and specificity of HarmoniaHPV that was non-inferior to GP5+/6 + EIA. Analytically, the test showed excellent intra- and inter-laboratory reproducibility, which improved further with the use of the optimised cut-offs. Conclusion: HarmoniaHPV when operated with optimised cut-offs fulfils the international clinical criteria for use in cervical cancer screening on SurePath samples. The optimised cut-offs warrant additional testing and independent validation.

AB - Aim: The VALidation of HPV GENotyping Tests (VALGENT) is a framework for comparison and validation of HPV tests with genotyping capabilities. In this study, the clinical performance of a single tube HPV test -HarmoniaHPV- was assessed in SurePath™ samples and compared to a clinically validated reference test, the GP5+/6+ Enzyme ImmunoAssay (GP5+/6 + EIA). Methods: HarmoniaHPV test is a real-time, PCR based, limited genotyping HPV test which detects 14 high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 with HPV16, and HPV 18 reported individually. Clinical performance was assessed using 998 unselected, cervical screening samples enriched with 297 cytologically abnormal specimens (100 atypical squamous cells of unspecified significance, 100 low-grade squamous intraepithelial lesions, 97 high-grade squamous intraepithelial lesions). Cases were defined as women diagnosed with histologically confirmed cervical intraepithelial neoplasia 2 or more (≥CIN2, N = 122). Results: Using the manufacturer recommended (un-adjusted) cut-offs, HarmoniaHPV had non-inferior sensitivity for detection of ≥ CIN2 but showed inferior specificity. A cut-off optimisation exercise was therefore carried out and optimised cut-offs for each individual channel rendered a sensitivity and specificity of HarmoniaHPV that was non-inferior to GP5+/6 + EIA. Analytically, the test showed excellent intra- and inter-laboratory reproducibility, which improved further with the use of the optimised cut-offs. Conclusion: HarmoniaHPV when operated with optimised cut-offs fulfils the international clinical criteria for use in cervical cancer screening on SurePath samples. The optimised cut-offs warrant additional testing and independent validation.

KW - HarmoniaHPV

KW - HPV screening

KW - HRHPV

KW - Valgent

UR - http://www.scopus.com/inward/record.url?scp=85105525196&partnerID=8YFLogxK

U2 - 10.1016/j.jviromet.2021.114161

DO - 10.1016/j.jviromet.2021.114161

M3 - Journal article

C2 - 33895238

VL - 294

JO - Journal of Virological Methods

JF - Journal of Virological Methods

SN - 0166-0934

M1 - 114161

ER -

ID: 65426982