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Analysis of HPV genotype-specific concordance between EUROArray HPV and HPV 3.5 LCD-Array Kit in cervical samples of 163 patients

  • Gynecologic Oncology
  • Published:
Archives of Gynecology and Obstetrics Aims and scope Submit manuscript

Abstract

Purpose

Human papilloma virus (HPV) as the most common viral infection of the anogenital tract is highly associated with intraepithelial neoplasia and cancer of the cervix and other anogential regions. To date, 15 high-risk (HR-) HPV and 3 probably/possibly HR-HPVs have been found to be associated with cervical cancer. Therefore, a screening especially for HR-HPV by appropriate tests is important for detection of precancerous lesions to prevent cancer. The purpose of this study was to analyze prospectively the concordance of the EUROArray HPV genotyping assay (Euroimmun; EUROArray) and the HPV 3.5 LCD-Array Kit (Chipron; LCD-Array).

Methods

Liquid-based, clinician-collected cervical cytology samples (n = 163) from women undergoing cervical inspection at the dysplasia consultation in the colposcopy clinic at the Medical Center—University of Freiburg, Germany were analyzed. Genotype-specific agreement was assessed by Cohen’s kappa statistic and McNemar’s P value of significance between proportions.

Results

Seventeen of the HR-HPV genotypes included in both assays were detected in 42.3% and 38% of samples by EUROArray and by LCD-Array, respectively; i.e. an agreement of 92.0% and a kappa value of 0.83 could be proven between the EUROArray and the LCD-Array. In 50 of 72 samples, identical HR-HPV genotypes were analyzed (81.9%, κ = 0.47) and genotyping for HPV 16 and/or 18 was highly concordant in both tests (relative agreement 96.3%, κ = 0.88). Detection of any HR-HPV was not significantly different after comparison of EUROArray with LCD-Array.

Conclusion

Both of the tests showed comparable results for the detection of HPV in cervical specimens and permit these assays to be suitable for routine diagnostics.

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Acknowledgements

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

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Authors and Affiliations

  1. Department of Gynecology and Obstetrics, University Medical Center Schleswig-Holstein, University of Lübeck, MFC VIII, Maria-Goeppert-Str. 9a, Campus Lübeck, 23562, Lübeck, Germany

    Karen Bräutigam, Sascha Baum, Frank Köster & Achim Rody

  2. Faculty of MedicineInstitute of Virology, University Medical Center—University of Freiburg, Freiburg, Germany

    Claudia Ehret, Verena Schillinger & Marcus Panning

  3. Department of Obstetrics and Gynecology, Faculty of Medicine, University Medical Center—University of Freiburg, Freiburg, Germany

    Maximilian Klar

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  1. Karen Bräutigam
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  4. Sascha Baum
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  5. Maximilian Klar
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Contributions

KB: data analysis, manuscript writing. CE, VS, MK: data collection or management. SB, FK, AR, MK: manuscript editing. MP: protocol/project development, manuscript editing.

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Correspondence to Karen Bräutigam.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee [local ethics committee of Freiburg University (10013/19)] and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.

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Bräutigam, K., Ehret, C., Schillinger, V. et al. Analysis of HPV genotype-specific concordance between EUROArray HPV and HPV 3.5 LCD-Array Kit in cervical samples of 163 patients. Arch Gynecol Obstet 301, 745–751 (2020). https://doi.org/10.1007/s00404-019-05427-y

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