title: Comparison of digene hybrid capture 2, GeneMatrix PapilloScreen, and a PCR sequencing assay in detecting high-risk and probable high-risk oncogenic HPV genotypes in specimens from Korean women.
abstract: Most cervical cancers are caused by 15 high-risk (HR) and three probable high-risk (pHR) oncogenic types of human papillomavirus (HPV). However, current commercial HR HPV screening test products do not include pHR HPV genotypes. Recently, PapilloScreen has been developed to detect the 15 HR and three pHR HPV types. In this study, we evaluated the concordance levels and clinical performance of Hybrid Capture 2 (HC2), PapilloScreen, and a PCR sequencing assay in detecting HR and pHR HPV. The PapilloScreen (96.8 %) and PCR sequencing assay (96.8 %) demonstrated higher sensitivity than HC2 (80.7 %) for detecting HR and pHR HPV. The three assays showed similar specificities and positive or negative predictive values. The concordance levels were 86.5 % (κ = 0.68) and 86.5 % (κ = 0.67) between HC2 and PapilloScreen and between HC2 and PCR sequencing, respectively. A near-perfect concordance was observed between PapilloScreen and PCR sequencing (97.8 %, κ = 0.95). Overall, the agreement between the three assays suggests that the results obtained by the HC2 assay are more often discordant (12.6 %) than the PCR-based tests. In conclusion, PapilloScreen is highly sensitive for detecting high-grade CIN or cervical cancer. The PapilloScreen assay should be considered an accurate and sensitive method for detecting HR and pHR HPV infections and an epidemiological tool for prevalence studies as well as early diagnosis and intervention in HR and pHR HPV infections.
authors.affiliation: Department of Obstetrics and Gynecology, KonKuk University School of Medicine, Seoul, Korea.
authors.forename: Jae-Man
authors.initials: JM
authors.lastname: Bae
authors.forename: Kyung Tae
authors.initials: KT
authors.lastname: Min
authors.forename: Ji Young
authors.initials: JY
authors.lastname: Shin
authors.forename: Soo-Kyung
authors.initials: SK
authors.lastname: Shin
authors.forename: Soo Nyung
authors.initials: SN
authors.lastname: Kim
authors.forename: Hyo-Pyo
authors.initials: HP
authors.lastname: Lee
authors.forename: Soo-Ok
authors.initials: SO
authors.lastname: Kim
authors.forename: Sun Pyo
authors.initials: SP
authors.lastname: Hong
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D052685:Alphapapillomavirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D004279:DNA, Viral / Q000235:genetics; D005260:Female; D005838:Genotype; D006801:Humans; D008875:Middle Aged; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods*; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000821:virology*; D016133:Polymerase Chain Reaction / Q000379:methods; D056910:Republic of Korea; D012680:Sensitivity and Specificity; D017422:Sequence Analysis, DNA / Q000379:methods*; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis / Q000821:virology*; D055815:Young Adult
chemical_list: D004279:DNA, Viral