title: EUROarray human papillomavirus (HPV) assay is highly concordant with other commercial assays for detection of high-risk HPV genotypes in women with high grade cervical abnormalities.
abstract: The purpose of this study was to evaluate the performance of the EUROIMMUN EUROArray HPV genotyping assay against the Roche Cobas 4800, Roche HPV Amplicor, Roche Linear Array and Qiagen Hybrid Capture 2 assays in the detection of high-risk HPV (HR-HPV) from liquid based cervical cytology samples collected from women undergoing follow-up for abnormal cervical cytology results. Cervical specimens from 404 women undergoing management of high-grade cytological abnormality were evaluated by EUROarray HPV for detection of HR-HPV genotypes and prediction of histologically-confirmed cervical intraepithelial neoplasia grade 2 or higher (≥CIN2). The results were compared to Hybrid Capture 2, Cobas 4800 HPV, Amplicor and Linear Array HPV. Positivity for 14 HR-HPV types was 80.0 % for EUROarray (95 % CI; 75.7-83.8 %). Agreement (κ, 95 % CI) between the EUROarray and other HPV tests for detection of HR-HPV was good to very good [Hybrid Capture κ = 0.62 (0.54-0.71); Cobas κ = 0.81 (0.74-0.88); Amplicor κ = 0.68 (0.60-0.77); Linear Array κ = 0.77 (0.70-0.85)]. For detection of HR-HPV, agreement with EUROarray was 87.90 % (Hybrid Capture), 93.58 % (Cobas), 92.84 % (Amplicor) and 92.59 % (Linear Array). Detection of HR-HPV was not significantly different between EUROarray and any other test (p < 0.001). EUROarray was concordant with other assays evaluated for detection of high-risk HPV and showed sensitivity and specificity for detection of ≥ CIN2 of 86 % and 71 %, respectively.
authors.affiliation: Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, 3052, Victoria, Australia. alyssa.cornall@mcri.edu.au.|Murdoch Childrens Research Institute, Parkville, 3052, Victoria, Australia. alyssa.cornall@mcri.edu.au.
authors.forename: A M
authors.initials: AM
authors.lastname: Cornall
authors.affiliation: Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, 3052, Victoria, Australia.|Murdoch Childrens Research Institute, Parkville, 3052, Victoria, Australia.
authors.forename: M
authors.initials: M
authors.lastname: Poljak
authors.affiliation: Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, 3052, Victoria, Australia.|Murdoch Childrens Research Institute, Parkville, 3052, Victoria, Australia.|Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, 3052, Victoria, Australia.
authors.forename: S M
authors.initials: SM
authors.lastname: Garland
authors.affiliation: Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, 3052, Victoria, Australia.|Murdoch Childrens Research Institute, Parkville, 3052, Victoria, Australia.
authors.forename: S
authors.initials: S
authors.lastname: Phillips
authors.affiliation: Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, 3052, Victoria, Australia.|Murdoch Childrens Research Institute, Parkville, 3052, Victoria, Australia.
authors.forename: D A
authors.initials: DA
authors.lastname: Machalek
authors.affiliation: Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, 3052, Victoria, Australia.|Oncology and Dysplasia Unit, Royal Women's Hospital, Parkville, 3052, Victoria, Australia.
authors.forename: J H
authors.initials: JH
authors.lastname: Tan
authors.affiliation: Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, 3052, Victoria, Australia.|Oncology and Dysplasia Unit, Royal Women's Hospital, Parkville, 3052, Victoria, Australia.
authors.forename: M A
authors.initials: MA
authors.lastname: Quinn
authors.affiliation: Regional HPV Lab Net Reference Laboratory, Department of Microbiology and Infectious Diseases, The Royal Women's Hospital, Parkville, 3052, Victoria, Australia.|Murdoch Childrens Research Institute, Parkville, 3052, Victoria, Australia.|Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, 3052, Victoria, Australia.
authors.forename: S N
authors.initials: SN
authors.lastname: Tabrizi
mesh_terms: D005260:Female; D005838:Genotype; D006801:Humans; D060787:Neoplasm Grading; D020411:Oligonucleotide Array Sequence Analysis / Q000379:methods / Q000592:standards; D027383:Papillomaviridae / Q000235:genetics*; D030361:Papillomavirus Infections / Q000150:complications / Q000175:diagnosis* / Q000821:virology*; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000209:etiology*
chemical_list: D011933:Reagent Kits, Diagnostic