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Anyplex II HPV28 detection and Anyplex II HPV HR detection assays are highly concordant with other commercial assays for detection of high-risk HPV genotypes in women with high grade cervical abnormalities

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European Journal of Clinical Microbiology & Infectious Diseases Aims and scope Submit manuscript

Abstract

Purpose: to evaluate the performance of Anyplex II HPV28 and HPV HR Detection assays against the EuroArray HPV, Cobas 4800 HPV (Cobas), HPV Amplicor (Amp), Linear Array HPV (LA) and Hybrid Capture 2 (HC2) in detection of high-risk HPV (HR-HPV) from liquid-based cervical cytology samples. Methods: cervical specimens from 404 women undergoing management of high-grade cytological abnormality were evaluated by Anyplex II HPV28 and HPV HR Detection assays for detection of HR-HPV genotypes and prediction of histologically-confirmed cervical intraepithelial neoplasia grade 2 or higher (≥CIN2). The results were compared to EuroArray, HC2, Cobas, Amp, and LA. Results: specimens were evaluated from 404 women with an average age of 30 years, including 336 with a histological diagnosis of ≥ CIN2 and 68 with ≤ CIN1. Concordance of HR-HPV detection between Anyplex II HPV28 and other genotyping assays was 94.79 % (κ = 0.84; EuroArray) and 97.27 % (κ = 0.91; LA); and between Anyplex II HPV HR and other HR-HPV detection assays was 86.35 % (κ = 0.62; HC2), 96.03 % (κ = 0.87; Cobas) and 96.77 % (κ = 0.89; Amp). Using HR-HPV detection for prediction of ≥ CIN2 by Anyplex II HPV28 and HPV HR, sensitivity (90.18, 95 % CI 86.48–93.14; 90.77, 95 % CI 87.16–93.65) and specificity (both 67.16, 95 % CI 54.60–78.15) were not significantly different to the other HPV assays tested, with one exception. Both Anyplex assays had significantly higher sensitivity than HC2 (p < 0.0001), with a specificity of 96 % (p > 0.05) of HC2 in this high-risk population. Conclusions: both Anyplex II HPV detection assays were concordant with other commercial assays for HR-HPV detection, with comparable sensitivity and specificity for ≥ CIN2 detection.

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Acknowledgments

All authors have read and approved the final manuscript. AC, SG, JH, MQ, and ST contributed to the study design. JT and MQ oversaw and performed clinical sample collection. MP and SP performed HPV genotype testing. DM evaluated the statistics. Seegene Inc. supplied the detection kits required for this study. The authors thank Hoa Kha from Integrated Sciences for technical support and advice.

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Correspondence to A. M. Cornall.

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Funding

Seegene Inc. supplied the detection kits required for this study. Seegene did not contribute to the design of the study, interpretation of results, or preparation of the manuscript. A member of the Seegene academic team was given the opportunity to comment on technical accuracy of the manuscript related to use of the assay.

Conflict of interest

Funding was supplied to SNT by Seegene Inc. for conference registration at EUROGIN 2016. All other authors declare that they have no conflict of interest.

Ethical approval

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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All participants gave informed consent for the procedures in this study. This article does not contain any studies with animals performed by any of the authors.

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Cornall, A.M., Poljak, M., Garland, S.M. et al. Anyplex II HPV28 detection and Anyplex II HPV HR detection assays are highly concordant with other commercial assays for detection of high-risk HPV genotypes in women with high grade cervical abnormalities. Eur J Clin Microbiol Infect Dis 36, 545–551 (2017). https://doi.org/10.1007/s10096-016-2831-5

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  • DOI: https://doi.org/10.1007/s10096-016-2831-5

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