Abstract
Roche Amplicor HPV (AMP) had previously been used for detection of high-risk human papillomavirus (HR-HPV) in epidemiological and clinical studies. As this assay is no longer available, we compared its performance using PreservCyt samples from women aged of 18–24 years attending for routine cervical cytology screening to Roche Cobas® 4800 (Cobas) to determine if subsequent studies could continue using the Cobas assay. Overall 507 samples were tested on Cobas and compared to previous AMP results, with discrepant samples tested on Roche Linear Array. Results: Overall, agreement between the Cobas and AMP for the presence of HR HPV types was very high (κ = 0.81) (95 % CI: 0.76 - 0.87) with percentage agreement of 91.57 %. Cobas is comparable to AMP for the detection of HR-HPV types in a community recruited cohort of healthy women.
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The funding for this study was provided by departmental funding.
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This study was endorsed by the Royal Women’s Hospital Human Research and Ethics Committees. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
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For this retrospective study formal consent was not required from participants. This article does not contain any studies with animals performed by any of the authors.
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Phillips, S., Cornall, A.M., Machalek, D.A. et al. Comparison of the Roche Cobas® 4800 HPV assay to Roche Amplicor for detection of high-risk human papillomavirus. Eur J Clin Microbiol Infect Dis 35, 1305–1307 (2016). https://doi.org/10.1007/s10096-016-2665-1
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DOI: https://doi.org/10.1007/s10096-016-2665-1