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EUROarray human papillomavirus (HPV) assay is highly concordant with other commercial assays for detection of high-risk HPV genotypes in women with high grade cervical abnormalities

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Abstract

The purpose of this study was to evaluate the performance of the EUROIMMUN EUROArray HPV genotyping assay against the Roche Cobas 4800, Roche HPV Amplicor, Roche Linear Array and Qiagen Hybrid Capture 2 assays in the detection of high-risk HPV (HR-HPV) from liquid based cervical cytology samples collected from women undergoing follow-up for abnormal cervical cytology results. Cervical specimens from 404 women undergoing management of high-grade cytological abnormality were evaluated by EUROarray HPV for detection of HR-HPV genotypes and prediction of histologically-confirmed cervical intraepithelial neoplasia grade 2 or higher (≥CIN2). The results were compared to Hybrid Capture 2, Cobas 4800 HPV, Amplicor and Linear Array HPV. Positivity for 14 HR-HPV types was 80.0 % for EUROarray (95 % CI; 75.7–83.8 %). Agreement (κ, 95 % CI) between the EUROarray and other HPV tests for detection of HR-HPV was good to very good [Hybrid Capture κ = 0.62 (0.54–0.71); Cobas κ = 0.81 (0.74–0.88); Amplicor κ = 0.68 (0.60–0.77); Linear Array κ = 0.77 (0.70–0.85)]. For detection of HR-HPV, agreement with EUROarray was 87.90 % (Hybrid Capture), 93.58 % (Cobas), 92.84 % (Amplicor) and 92.59 % (Linear Array). Detection of HR-HPV was not significantly different between EUROarray and any other test (p < 0.001). EUROarray was concordant with other assays evaluated for detection of high-risk HPV and showed sensitivity and specificity for detection of ≥ CIN2 of 86 % and 71 %, respectively.

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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. Euroimmun AG supplied the detection kits required for this study. The authors thank Andreas Wilcke and Markus Cavalar from Euroimmun for their technical support and advice.

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Authors and Affiliations

  1. Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women’s Hospital, Parkville, 3052, Victoria, Australia

    A. M. Cornall, M. Poljak, S. M. Garland, S. Phillips, D. A. Machalek & S. N. Tabrizi

  2. Murdoch Childrens Research Institute, Parkville, 3052, Victoria, Australia

    A. M. Cornall, M. Poljak, S. M. Garland, S. Phillips, D. A. Machalek & S. N. Tabrizi

  3. Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, 3052, Victoria, Australia

    S. M. Garland, J. H. Tan, M. A. Quinn & S. N. Tabrizi

  4. Oncology and Dysplasia Unit, Royal Women’s Hospital, Parkville, 3052, Victoria, Australia

    J. H. Tan & M. A. Quinn

Authors
  1. A. M. Cornall
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  2. M. Poljak
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  3. S. M. Garland
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  4. S. Phillips
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  5. D. A. Machalek
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  6. J. H. Tan
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  7. M. A. Quinn
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  8. S. N. Tabrizi
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Corresponding author

Correspondence to A. M. Cornall.

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Funding

Euroimmun AG supplied the detection kits required for this study.

Conflict of interest

All 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.

Informed consent

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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Cornall, A.M., Poljak, M., Garland, S.M. et al. EUROarray human papillomavirus (HPV) assay is 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 35, 1033–1036 (2016). https://doi.org/10.1007/s10096-016-2634-8

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  • DOI: https://doi.org/10.1007/s10096-016-2634-8

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