title: Comparison of the analytical and clinical performances of Abbott RealTime High Risk HPV, Hybrid Capture 2, and DNA Chip assays in gynecology patients.
abstract: The detection of high-risk (HR) HPV in cervical cancer screening is important for early diagnosis of cervical cancer or pre-cancerous lesions. We evaluated the analytical and clinical performances of 3 HR HPV assays in Gynecology patients. A total of 991 specimens were included in this study: 787 specimens for use with a Hybrid Capture 2 (HC2) and 204 specimens for a HPV DNA microarray (DNA Chip). All specimens were tested using an Abbott RealTime High Risk HPV assay (Real-time HR), PGMY PCR, and sequence analysis. Clinical sensitivities for severe abnormal cytology (severe than high-grade squamous intraepithelial lesion) were 81.8% for Real-time HR, 77.3% for HC2, and 66.7% for DNA Chip, and clinical sensitivities for severe abnormal histology (cervical intraepithelial neoplasia grade 2+) were 91.7% for HC2, 87.5% for Real-time HR, and 73.3% for DNA Chip. As compared to results of the sequence analysis, HC2, Real-time HR, and DNA Chip showed concordance rates of 94.3% (115/122), 90.0% (117/130), and 61.5% (16/26), respectively. The HC2 assay and Real-time HR assay showed comparable results to each other in both clinical and analytical performances, while the DNA Chip assay showed poor clinical and analytical performances. The Real-time HR assay can be a good alternative option for HR HPV testing with advantages of allowing full automation and simultaneous genotyping of HR types 16 and 18.
authors.affiliation: Department of Laboratory Medicine, Seoul National University Hospital, Seoul, South Korea.
authors.forename: Seungman
authors.initials: S
authors.lastname: Park
authors.forename: Youjin
authors.initials: Y
authors.lastname: Kang
authors.forename: Dong Geun
authors.initials: DG
authors.lastname: Kim
authors.forename: Eui-Chong
authors.initials: EC
authors.lastname: Kim
authors.forename: Sung Sup
authors.initials: SS
authors.lastname: Park
authors.forename: Moon-Woo
authors.initials: MW
authors.lastname: Seong
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002584:Cervix Uteri / Q000473:pathology / Q000821:virology; D055088:Early Detection of Cancer; D005260:Female; D061809:Human Papillomavirus DNA Tests / Q000592:standards*; D052162:Human papillomavirus 16 / Q000235:genetics* / Q000302:isolation & purification; D052161:Human papillomavirus 18 / Q000235:genetics* / Q000302:isolation & purification; D006801:Humans; D008875:Middle Aged; D058889:Molecular Typing; D060787:Neoplasm Grading; D020411:Oligonucleotide Array Sequence Analysis; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D016133:Polymerase Chain Reaction; D011247:Pregnancy; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology
chemical_list: D011933:Reagent Kits, Diagnostic
keywords: Chip; HC2; HPV; Performance; Real-time PCR