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Comparison between the Roche Cobas 4800 human papillomavirus (HPV), Abbott RealTime high-risk HPV, Seegene Anyplex II HPV28, and novel Seegene Allplex II HPV28 assays for high-risk HPV detection and genotyping in mocked self-samples

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  • ELEVATE (Early detection of cervical cancer in hard-to-reach populations of women through portable and point-of-care HPV testing)
Abstract
This study proves that the novel Allplex II HPV28 assay has a good diagnostic performance in comparison with the well-known, validated, and frequently used Roche Cobas 4800, Abbott RealTime, and Anyplex II HPV28 assays. According to our experience, the novel Allplex II HPV28 assay had a user-friendly and automated workflow with short hands-on time, had an open platform which facilitates the use of add-on assays, and provided quick and easy-to-interpret results. Infection with high-risk human papillomavirus (hrHPV) is well recognized as the main cause of cervical cancer. The recently developed Seegene Allplex II HPV28 assay is a novel quantitative PCR (qPCR) assay designed to separately detect and quantify 28 distinct HPV genotypes in a fully automated and user-friendly manner. This study evaluated and compared the performance of this new assay with the performance of the Roche Cobas 4800, the Abbott RealTime high-risk HPV, and the Seegene Anyplex II HPV28 assays. A total of 114 mocked self-samples, i.e., semicervical samples collected by gynecologists using the Viba-Brush, were analyzed with all four HPV assays. Agreement in terms of detecting and genotyping HPV was assessed by the mean of the Cohen's kappa (kappa) coefficient. Results of all four HPV assays agreed in 85.9% of the cases when using the Abbott RealTime manufacturer's recommended quantification cycle (C-q) cutoff for positivity (<32.00) and 91.2% when using an adapted range (32.00 to 36.00). An intercomparison of the included assays demonstrated an overall agreement ranging from 85.9 to 100.0% (kappa = 0.42 to 1.00) when using the manufacturer's guidelines and 92.9 to 100.0% (kappa = 0.60 to 1.00) with the adapted range. For all assays, highly significant, strongly positive Pearson correlations were shown between the C-q values of positive test results. This study thereby shows high concordance between results of the included HPV assays on mocked self-samples. Based on these findings, we imply that the novel Allplex II HPV28 assay demonstrates a comparable performance to those of available qPCR HPV assays, potentially providing opportunities for the simplification and standardization of future large-scale testing.IMPORTANCE This study proves that the novel Allplex II HPV28 assay has a good diagnostic performance in comparison with the well-known, validated, and frequently used Roche Cobas 4800, Abbott RealTime, and Anyplex II HPV28 assays. According to our experience, the novel Allplex II HPV28 assay had a user-friendly and automated workflow with short hands-on time, had an open platform which facilitates the use of add-on assays, and provided quick and easy-to-interpret results. Together with its ability to detect and quantify 28 HPV genotypes, the Allplex II HPV28 assay could therefore potentially provide opportunities for the simplification and standardization of future diagnostic testing programs.
Keywords
Infectious Diseases, Cell Biology, Microbiology (medical), Genetics, General Immunology and Microbiology, Ecology, Physiology

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Citation

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MLA
Bell, Margo, et al. “Comparison between the Roche Cobas 4800 Human Papillomavirus (HPV), Abbott RealTime High-Risk HPV, Seegene Anyplex II HPV28, and Novel Seegene Allplex II HPV28 Assays for High-Risk HPV Detection and Genotyping in Mocked Self-Samples.” MICROBIOLOGY SPECTRUM, edited by Salika M. Shakir, vol. 11, no. 4, American Society for Microbiology, 2023, doi:10.1128/spectrum.00081-23.
APA
Bell, M., Verberckmoes, B., Devolder, J., Vermandere, H., Degomme, O., Guimarães, Y. M., … Padalko, E. (2023). Comparison between the Roche Cobas 4800 human papillomavirus (HPV), Abbott RealTime high-risk HPV, Seegene Anyplex II HPV28, and novel Seegene Allplex II HPV28 assays for high-risk HPV detection and genotyping in mocked self-samples. MICROBIOLOGY SPECTRUM, 11(4). https://doi.org/10.1128/spectrum.00081-23
Chicago author-date
Bell, Margo, Bo Verberckmoes, Janne Devolder, Heleen Vermandere, Olivier Degomme, Yasmin Medeiros Guimarães, Luani Rezende Godoy, Elena Ambrosino, Piet Cools, and Elizaveta Padalko. 2023. “Comparison between the Roche Cobas 4800 Human Papillomavirus (HPV), Abbott RealTime High-Risk HPV, Seegene Anyplex II HPV28, and Novel Seegene Allplex II HPV28 Assays for High-Risk HPV Detection and Genotyping in Mocked Self-Samples.” Edited by Salika M. Shakir. MICROBIOLOGY SPECTRUM 11 (4). https://doi.org/10.1128/spectrum.00081-23.
Chicago author-date (all authors)
Bell, Margo, Bo Verberckmoes, Janne Devolder, Heleen Vermandere, Olivier Degomme, Yasmin Medeiros Guimarães, Luani Rezende Godoy, Elena Ambrosino, Piet Cools, and Elizaveta Padalko. 2023. “Comparison between the Roche Cobas 4800 Human Papillomavirus (HPV), Abbott RealTime High-Risk HPV, Seegene Anyplex II HPV28, and Novel Seegene Allplex II HPV28 Assays for High-Risk HPV Detection and Genotyping in Mocked Self-Samples.” Ed by. Salika M. Shakir. MICROBIOLOGY SPECTRUM 11 (4). doi:10.1128/spectrum.00081-23.
Vancouver
1.
Bell M, Verberckmoes B, Devolder J, Vermandere H, Degomme O, Guimarães YM, et al. Comparison between the Roche Cobas 4800 human papillomavirus (HPV), Abbott RealTime high-risk HPV, Seegene Anyplex II HPV28, and novel Seegene Allplex II HPV28 assays for high-risk HPV detection and genotyping in mocked self-samples. Shakir SM, editor. MICROBIOLOGY SPECTRUM. 2023;11(4).
IEEE
[1]
M. Bell et al., “Comparison between the Roche Cobas 4800 human papillomavirus (HPV), Abbott RealTime high-risk HPV, Seegene Anyplex II HPV28, and novel Seegene Allplex II HPV28 assays for high-risk HPV detection and genotyping in mocked self-samples,” MICROBIOLOGY SPECTRUM, vol. 11, no. 4, 2023.
@article{01H4FZD7MX64Q6NMWJ5ZJE7P4G,
  abstract     = {{This study proves that the novel Allplex II HPV28 assay has a good diagnostic performance in comparison with the well-known, validated, and frequently used Roche Cobas 4800, Abbott RealTime, and Anyplex II HPV28 assays. According to our experience, the novel Allplex II HPV28 assay had a user-friendly and automated workflow with short hands-on time, had an open platform which facilitates the use of add-on assays, and provided quick and easy-to-interpret results.

Infection with high-risk human papillomavirus (hrHPV) is well recognized as the main cause of cervical cancer. The recently developed Seegene Allplex II HPV28 assay is a novel quantitative PCR (qPCR) assay designed to separately detect and quantify 28 distinct HPV genotypes in a fully automated and user-friendly manner. This study evaluated and compared the performance of this new assay with the performance of the Roche Cobas 4800, the Abbott RealTime high-risk HPV, and the Seegene Anyplex II HPV28 assays. A total of 114 mocked self-samples, i.e., semicervical samples collected by gynecologists using the Viba-Brush, were analyzed with all four HPV assays. Agreement in terms of detecting and genotyping HPV was assessed by the mean of the Cohen's kappa (kappa) coefficient. Results of all four HPV assays agreed in 85.9% of the cases when using the Abbott RealTime manufacturer's recommended quantification cycle (C-q) cutoff for positivity (<32.00) and 91.2% when using an adapted range (32.00 to 36.00). An intercomparison of the included assays demonstrated an overall agreement ranging from 85.9 to 100.0% (kappa = 0.42 to 1.00) when using the manufacturer's guidelines and 92.9 to 100.0% (kappa = 0.60 to 1.00) with the adapted range. For all assays, highly significant, strongly positive Pearson correlations were shown between the C-q values of positive test results. This study thereby shows high concordance between results of the included HPV assays on mocked self-samples. Based on these findings, we imply that the novel Allplex II HPV28 assay demonstrates a comparable performance to those of available qPCR HPV assays, potentially providing opportunities for the simplification and standardization of future large-scale testing.IMPORTANCE This study proves that the novel Allplex II HPV28 assay has a good diagnostic performance in comparison with the well-known, validated, and frequently used Roche Cobas 4800, Abbott RealTime, and Anyplex II HPV28 assays. According to our experience, the novel Allplex II HPV28 assay had a user-friendly and automated workflow with short hands-on time, had an open platform which facilitates the use of add-on assays, and provided quick and easy-to-interpret results. Together with its ability to detect and quantify 28 HPV genotypes, the Allplex II HPV28 assay could therefore potentially provide opportunities for the simplification and standardization of future diagnostic testing programs.}},
  articleno    = {{00081-23}},
  author       = {{Bell, Margo and Verberckmoes, Bo and Devolder, Janne and Vermandere, Heleen and Degomme, Olivier and Guimarães, Yasmin Medeiros and Godoy, Luani Rezende and Ambrosino, Elena and Cools, Piet and Padalko, Elizaveta}},
  editor       = {{Shakir, Salika M.}},
  issn         = {{2165-0497}},
  journal      = {{MICROBIOLOGY SPECTRUM}},
  keywords     = {{Infectious Diseases,Cell Biology,Microbiology (medical),Genetics,General Immunology and Microbiology,Ecology,Physiology}},
  language     = {{eng}},
  number       = {{4}},
  pages        = {{11}},
  publisher    = {{American Society for Microbiology}},
  title        = {{Comparison between the Roche Cobas 4800 human papillomavirus (HPV), Abbott RealTime high-risk HPV, Seegene Anyplex II HPV28, and novel Seegene Allplex II HPV28 assays for high-risk HPV detection and genotyping in mocked self-samples}},
  url          = {{http://doi.org/10.1128/spectrum.00081-23}},
  volume       = {{11}},
  year         = {{2023}},
}

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