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Comparison of high-risk HPV detection by the AmpFire® HPV Screening 16/18/HR technique (Atila Biosystems) and the hybrid capture 2 test (Qiagen)

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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.


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.


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.


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.

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Data availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.


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The authors would like to thank the Fujirebio Company for providing the kits used for this comparison.


Inserm CIC1431 received funding from Fujirebio for statistical analysis. The funder had no role in the design and interpretation of the data.

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Authors and Affiliations



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

Correspondence to Quentin Lepiller.

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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).

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The authors declare no competing interests.

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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).

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