Abstract
Background
Detection of high-risk human papillomaviruses (hrHPV) is widely used at the first line of cervical cancer screening, requiring rigorous validation of the clinical performance of commercial kits designed for this indication.
Methods
Performance of the AmpFire HPV Screening 16/18/HR test (AF, Atila Biosystems) and the Hybrid Capture 2 test (HC2, Qiagen) for detecting hrHPV was cross-compared in 200 cervical samples in our institution.
Results
The global percentage of agreement between the 2 techniques was 95.0% (95%CI 92–98%) with a Cohen’s kappa coefficient of 0.85 (95%CI 0.75–0.94). Ten samples showed discordant results between the 2 techniques in both directions (5 HC2+/AF- and 5 HC2-/AF+). Among possible explanations for these discrepancies was the detection of HPV66 and HPV53 genotypes in two samples, since these genotypes are targeted by the Ampfire test but not by the HC2 test, as well as intrinsic differences in analytical performance to target specific genotypes.
Conclusions
A high level of agreement was observed between the two techniques, which encourages further testing in order to definitively validate the use of the Ampfire kit for primary cervical cancer screening.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
Data availability
The data that support the findings of this study are available from the corresponding author upon reasonable request.
References
de Martel C, Plummer M, Vignat J, Franceschi S (2017) Worldwide burden of cancer attributable to HPV by site, country and HPV type. Int J Cancer 141:664–670. https://doi.org/10.1002/ijc.30716
Schiffman M, Doorbar J, Wentzensen N et al (2016) Carcinogenic human papillomavirus Infection. Nat Rev Dis Primer 2:16086. https://doi.org/10.1038/nrdp.2016.86
Bzhalava D, Eklund C, Dillner J (2015) International standardization and classification of human papillomavirus types. Virology 476:341–344. https://doi.org/10.1016/j.virol.2014.12.028
de Sanjosé S, Serrano B, Tous S et al (2018) Burden of human papillomavirus (HPV)-Related cancers attributable to HPVs 6. JNCI Cancer Spectr 2 and 58:pky045. 11/16/18/31/33/45/52
Arbyn M, Simon M, Peeters E et al (2021) 2020 list of human papillomavirus assays suitable for primary Cervical cancer screening. Clin Microbiol Infect off Publ Eur Soc Clin Microbiol Infect Dis 27:1083–1095. https://doi.org/10.1016/j.cmi.2021.04.031
Meijer CJLM, Berkhof J, Castle PE et al (2009) Guidelines for human papillomavirus DNA test requirements for primary Cervical cancer screening in women 30 years and older. Int J Cancer 124:516–520. https://doi.org/10.1002/ijc.24010
Debernardi A, Jarassier W, Soret C et al (2021) Repurposing the Hybrid capture 2 (HC2) screening test for whole-genome sequencing of human papillomaviruses. Arch Virol 166:3421–3425. https://doi.org/10.1007/s00705-021-05259-9
Cohen J (1960) A coefficient of Agreement for Nominal scales. Educ Psychol Meas 20:37–46. https://doi.org/10.1177/001316446002000104
Fleiss JL, Cohen J, Everitt BS (1969) Large sample standard errors of kappa and weighted kappa. Psychol Bull 72:323
Xu L, Padalko E, Oštrbenk A et al (2018) Clinical evaluation of INNO-LiPA HPV genotyping EXTRA II assay using the VALGENT Framework. Int J Mol Sci 19:2704. https://doi.org/10.3390/ijms19092704
Zhang W, Du H, Huang X et al (2020) Evaluation of an isothermal amplification HPV detection assay for primary Cervical cancer screening. Infect Agent Cancer 15:65. https://doi.org/10.1186/s13027-020-00328-1
Acknowledgements
The authors would like to thank the Fujirebio Company for providing the kits used for this comparison.
Funding
Inserm CIC1431 received funding from Fujirebio for statistical analysis. The funder had no role in the design and interpretation of the data.
Author information
Authors and Affiliations
Contributions
AK and AB: Investigation MD: conceptualization, statistical analysis, data curation KD: statistical analysis, data curation LP: writing review and editing QL: statistical analysis, data curation, writing original draft JLP: conceptualization, Resources, writing review and editing, project administration.
Corresponding author
Ethics declarations
Ethical approval
This study was conducted in accordance with the amended Declaration of Helsinki. All used samples were stored into a biobank for which a declaration of preparation and storage of human samples for research use has been sent to the « Ministère de l’Enseignement Supérieur et de la Recherche » (n°DC-2014-2086).
Competing interests
The authors declare no competing interests.
Additional information
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
About this article
Cite this article
Koussouri, A., Baraquin, A., Desmarets, M. et al. Comparison of high-risk HPV detection by the AmpFire® HPV Screening 16/18/HR technique (Atila Biosystems) and the hybrid capture 2 test (Qiagen). Mol Biol Rep 51, 52 (2024). https://doi.org/10.1007/s11033-023-08939-8
Received:
Accepted:
Published:
DOI: https://doi.org/10.1007/s11033-023-08939-8