A Technical Comparison of Human Papillomavirus Genotyping Assays from a Population-Based Cervical Cancer Screening in South Central Ethiopia

Brhanu Teka; Muluken Gizaw; Ededia Firdawoke; Adamu Addissie; Tesfamichael Awoke Sisay; Carola Schreckenberger; Anna Sophie Skof; Sarah Thies; Adane Mihret; Eva Johanna Kantelhardt; Tamrat Abebe; Andreas M Kaufmann

doi:10.2147/CMAR.S360712

A Technical Comparison of Human Papillomavirus Genotyping Assays from a Population-Based Cervical Cancer Screening in South Central Ethiopia

Cancer Manag Res. 2022 Jul 29:14:2253-2263. doi: 10.2147/CMAR.S360712. eCollection 2022.

Authors

Brhanu Teka^{1

2}, Muluken Gizaw^{2

3

4}, Ededia Firdawoke¹, Adamu Addissie³, Tesfamichael Awoke Sisay³, Carola Schreckenberger⁵, Anna Sophie Skof⁵, Sarah Thies⁵, Adane Mihret^{1

6}, Eva Johanna Kantelhardt^{2

4}, Tamrat Abebe¹, Andreas M Kaufmann⁵

Affiliations

¹ Department of Microbiology, Immunology and Parasitology, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
² Department of Gynaecology Martin-Luther-University, Halle-Wittenberg, Germany.
³ School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
⁴ Institute for Medical Epidemiology, Biometrics and Informatics, Martin-Luther-University, Halle-Wittenberg, Germany.
⁵ Department of Gynecology, Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, 13353, Germany.
⁶ Armauer Hansen Research Institute (AHRI), Addis Ababa, Ethiopia.

Abstract

Purpose: 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.

Keywords: HPV PCR test accuracy; HPV test complexity; HPV testing; LMIC; analytical performance.

Associated data

ClinicalTrials.gov/NCT03281135

Grants and funding

This study was supported by Addis Ababa University, grant/award number: VPRTT/PY-041/2018 and BMZ/Else Kröner Fresenius-Stiftung; Else-Kröner-Fresenius Foundation. We acknowlege the financial support from the Open Access Publication Fund of Charite- Universitaetsmedizin Berlin and the German Research Foundation (DFG).