A technical comparison of human papillomavirus genotyping assays from a population-based cervical cancer screening in south central Ethiopia

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dc.contributor.authorTeka, Brhanu
dc.contributor.authorGizaw, Muluken
dc.contributor.authorFirdawoke, Ededia
dc.contributor.authorAddissie, Adamu
dc.contributor.authorSisay, Tesfamichael Awoke
dc.contributor.authorSchreckenberger, Carola
dc.contributor.authorSkof, Anna Sophie
dc.contributor.authorThies, Sarah
dc.contributor.authorMihret, Adane
dc.contributor.authorKantelhardt, Eva Johanna
dc.contributor.authorAbebe, Tamrat
dc.contributor.authorKaufmann, Andreas M
dc.date.accessioned2023-03-01T18:42:20Z
dc.date.available2023-03-01T18:42:20Z
dc.date.issued2022-07-29
dc.description.abstractPurpose: High-risk Human Papillomavirus (HPV) is the most important cause of cervical cancer. The highest burden of disease is seen in Low- and Low-Middle-Income Countries (LMIC). Several new HPV screening assays have been developed for high-risk HPV (hr-HPV) testing. We compared the performance and adequacy of three HPV genotyping assays on samples from a population of rural women in south-central Ethiopia. Patients and Methods: One hundred and ten cervical swabs from rural women screened for HPV were assayed. HPV DNA was tested using MPG-Luminex Assay, Anyplex II HPV HR Detection, and EUROArray HPV. MPG-Luminex Assay was used as a reference method to compute the sensitivity and specificity of the two commercial assays in detecting hr-HPV infections. Results: Of the 110 samples, MPG-Luminex Assay found 18.2% positive for the 14 hr-HPV and 7.3% for the probable hr-HPV genotypes. Anyplex™ II HPV HR Detection assay and EUROArray HPV Assay identified 21.82% and 12.7% samples, respectively, for the 14 hr-HPVs and both 7.3% for the probable hr-HPV genotypes (κ=0.734). Among the 14 hr-HPV genotypes, the genotype-specific agreement of the three HPV genotyping assays was moderate or better for HPV16, 31, 35, 39, 52, 56, 66 and 68. The aggregated sensitivity in detecting the 14 hr-HPV infections of Anyplex™ II HPV HR Detection and EUROArray HPV assays was high, 100% and 70%, respectively. The specificities of Anyplex™ II HPV HR Detection and EUROArray HPV were 95.6% and 100%, respectively. Conclusion: The three evaluated assays showed similar analytical performance in the detection of hr-HPV infections and moderate or better concordance in HPV genotyping. This study is part of the ongoing cluster-randomized trial that has been registered in clinicaltrials.gov (NCT03281135) on September 13, 2017.en_US
dc.identifier.citationTeka, B., Gizaw, M., Firdawoke, E., Addissie, A., Sisay, T. A., Schreckenberger, C., Skof, A. S., Thies, S., Mihret, A., Kantelhardt, E. J., Abebe, T., & Kaufmann, A. M. (2022). A Technical Comparison of Human Papillomavirus Genotyping Assays from a Population-Based Cervical Cancer Screening in South Central Ethiopia. Cancer management and research, 14, 2253–2263. https://doi.org/10.2147/CMAR.S360712en_US
dc.identifier.otherDOI: 10.2147/CMAR.S360712
dc.identifier.urihttps://hdl.handle.net/20.500.14041/5946
dc.language.isoen_USen_US
dc.publisherCancer Management and Researchen_US
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/us/*
dc.subjectAnalytical Performanceen_US
dc.subjectHPV PCR Test Accuracyen_US
dc.subjectHPV Test Complexityen_US
dc.subjectHPV Testingen_US
dc.subjectLMICen_US
dc.titleA technical comparison of human papillomavirus genotyping assays from a population-based cervical cancer screening in south central Ethiopiaen_US
dc.typeArticleen_US
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