PMID- 35937937 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220809 IS - 1179-1322 (Print) IS - 1179-1322 (Electronic) IS - 1179-1322 (Linking) VI - 14 DP - 2022 TI - A Technical Comparison of Human Papillomavirus Genotyping Assays from a Population-Based Cervical Cancer Screening in South Central Ethiopia. PG - 2253-2263 LID - 10.2147/CMAR.S360712 [doi] AB - 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 (kappa=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. CI - (c) 2022 Teka et al. FAU - Teka, Brhanu AU - Teka B AUID- ORCID: 0000-0002-0124-6008 AD - Department of Microbiology, Immunology and Parasitology, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia. AD - Department of Gynaecology Martin-Luther-University, Halle-Wittenberg, Germany. FAU - Gizaw, Muluken AU - Gizaw M AUID- ORCID: 0000-0002-6500-5852 AD - Department of Gynaecology Martin-Luther-University, Halle-Wittenberg, Germany. AD - School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia. AD - Institute for Medical Epidemiology, Biometrics and Informatics, Martin-Luther-University, Halle-Wittenberg, Germany. FAU - Firdawoke, Ededia AU - Firdawoke E AUID- ORCID: 0000-0002-6357-2044 AD - Department of Microbiology, Immunology and Parasitology, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia. FAU - Addissie, Adamu AU - Addissie A AUID- ORCID: 0000-0003-4709-3606 AD - School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia. FAU - Sisay, Tesfamichael Awoke AU - Sisay TA AUID- ORCID: 0000-0003-4517-8542 AD - School of Public Health, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia. FAU - Schreckenberger, Carola AU - Schreckenberger C AUID- ORCID: 0000-0001-5514-5977 AD - Department of Gynecology, Charite - Universitatsmedizin Berlin, Corporate Member of Freie Universitat Berlin and Humboldt-Universitat zu Berlin, Berlin, 13353, Germany. FAU - Skof, Anna Sophie AU - Skof AS AUID- ORCID: 0000-0003-2393-1572 AD - Department of Gynecology, Charite - Universitatsmedizin Berlin, Corporate Member of Freie Universitat Berlin and Humboldt-Universitat zu Berlin, Berlin, 13353, Germany. FAU - Thies, Sarah AU - Thies S AUID- ORCID: 0000-0002-4373-3859 AD - Department of Gynecology, Charite - Universitatsmedizin Berlin, Corporate Member of Freie Universitat Berlin and Humboldt-Universitat zu Berlin, Berlin, 13353, Germany. FAU - Mihret, Adane AU - Mihret A AUID- ORCID: 0000-0003-3183-4772 AD - Department of Microbiology, Immunology and Parasitology, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia. AD - Armauer Hansen Research Institute (AHRI), Addis Ababa, Ethiopia. FAU - Kantelhardt, Eva Johanna AU - Kantelhardt EJ AUID- ORCID: 0000-0001-7935-719X AD - Department of Gynaecology Martin-Luther-University, Halle-Wittenberg, Germany. AD - Institute for Medical Epidemiology, Biometrics and Informatics, Martin-Luther-University, Halle-Wittenberg, Germany. FAU - Abebe, Tamrat AU - Abebe T AUID- ORCID: 0000-0002-6100-9303 AD - Department of Microbiology, Immunology and Parasitology, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia. FAU - Kaufmann, Andreas M AU - Kaufmann AM AUID- ORCID: 0000-0001-7732-3009 AD - Department of Gynecology, Charite - Universitatsmedizin Berlin, Corporate Member of Freie Universitat Berlin and Humboldt-Universitat zu Berlin, Berlin, 13353, Germany. LA - eng SI - ClinicalTrials.gov/NCT03281135 PT - Journal Article DEP - 20220729 PL - New Zealand TA - Cancer Manag Res JT - Cancer management and research JID - 101512700 PMC - PMC9346300 OTO - NOTNLM OT - HPV PCR test accuracy OT - HPV test complexity OT - HPV testing OT - LMIC OT - analytical performance COIS- The authors declare that they have no conflicts of interest in relation to this work. EDAT- 2022/08/09 06:00 MHDA- 2022/08/09 06:01 PMCR- 2022/07/29 CRDT- 2022/08/08 04:10 PHST- 2022/02/01 00:00 [received] PHST- 2022/05/27 00:00 [accepted] PHST- 2022/08/08 04:10 [entrez] PHST- 2022/08/09 06:00 [pubmed] PHST- 2022/08/09 06:01 [medline] PHST- 2022/07/29 00:00 [pmc-release] AID - 360712 [pii] AID - 10.2147/CMAR.S360712 [doi] PST - epublish SO - Cancer Manag Res. 2022 Jul 29;14:2253-2263. doi: 10.2147/CMAR.S360712. eCollection 2022.