Analysis of HPV genotype-specific concordance between EUROArray HPV and HPV 3.5 LCD-Array Kit in cervical samples of 163
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GYNECOLOGIC ONCOLOGY
Analysis of HPV genotype‑specific concordance between EUROArray HPV and HPV 3.5 LCD‑Array Kit in cervical samples of 163 patients Karen Bräutigam1 · Claudia Ehret2 · Verena Schillinger2 · Sascha Baum1 · Maximilian Klar3 · Frank Köster1 · Achim Rody1 · Marcus Panning2 Received: 20 August 2019 / Accepted: 17 December 2019 © Springer-Verlag GmbH Germany, part of Springer Nature 2019
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. Keywords HPV · Virus classification · Genital tract · Test statistics
Introduction
* Karen Bräutigam [email protected] 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
2
Faculty of MedicineInstitute of Virology, University Medical Center—University of Freiburg, Freiburg, Germany
3
Department of Obstetrics and Gynecology, Faculty of Medicine, University Medical Center—University of Freiburg, Freiburg, Germany
Human papilloma virus (HPV)-attributable cancers came to the fore in the last years. Apart from cervical cancer that is related to HPV infection in more than 99% of the cases, the incidence of other anogenital cancers as well as oropharyngeal cancers increased from 50 (vulvar) up to 90% (anal) of cancer cases being associated with HPV infection
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