title: Clinical Validation of Anyplex II HPV HR Detection Test for Cervical Cancer Screening in Korea.
abstract: BACKGROUND
  The Anyplex II HPV HR detection kit (Seegene Inc, Seoul, Korea) is a new, multiplex, real-time polymerase chain reaction assay to detect individual 14 high-risk (HR) human papillomavirus (HPV) types in a single tube.
  
  
  OBJECTIVE
  To evaluate the clinical performance of the HPV HR kit in predicting high-grade squamous intraepithelial lesions and cervical intraepithelial lesions grade 2 or worse in cervical cancer screening.
  
  
  METHODS
  We analyzed 1137 cervical samples in Huro Path medium (CelltraZone, Seoul, Korea) from Korean women. The clinical performance of the HPV HR kit was compared with Hybrid Capture 2 (Qiagen, Valencia, California) using the noninferiority score test in a routine cervical cancer screening setting. The intralaboratory and interlaboratory agreements of HPV HR were also evaluated.
  
  
  RESULTS
  Overall agreement between the 2 assays was 92.4% (1051 of 1137) with a κ value of 0.787. Clinical sensitivity of HPV HR for high-grade squamous intraepithelial lesions and cervical intraepithelial lesions grade 2 or worse was 94.4% (95% confidence interval [CI], 89.2-99.7) and 92.5% (95% CI, 84.3-100.0), respectively. The respective values for Hybrid Capture 2 were 93.1% (95% CI, 87.2-98.9) and 87.5% (95% CI, 77.3-99.7). Clinical sensitivity and specificity of HPV HR were not inferior to those of Hybrid Capture 2 (P = .005 and P = .04, respectively). The HPV HR showed good intralaboratory and interlaboratory reproducibility at 98.0% (κ = 0.953) and 97.4% (κ = 0.940), respectively.
  
  
  CONCLUSIONS
  The HPV HR demonstrates comparable performance to the Hybrid Capture 2 test and can be useful for HPV-based cervical cancer screening testing.
authors.affiliation: From the Molecular Diagnostics Testing Center (Drs Jung and K. N. Lee).
authors.forename: Sunkyung
authors.initials: S
authors.lastname: Jung
authors.affiliation: and the Department of Pathology (Dr B. Lee).
authors.forename: Byungdoo
authors.initials: B
authors.lastname: Lee
authors.affiliation: Seegene Medical Foundation, Seocho-gu, Seoul, Republic of Korea; and the Department of Laboratory Medicine, College of Medicine, Seoul St. Mary's Hospital, Catholic University of Korea (Drs Kim and Oh).
authors.forename: Kap No
authors.initials: KN
authors.lastname: Lee
authors.forename: Yonggoo
authors.initials: Y
authors.lastname: Kim
authors.forename: Eun-Jee
authors.initials: EJ
authors.lastname: Oh
mesh_terms: D000328:Adult; D052685:Alphapapillomavirus / Q000145:classification / Q000302:isolation & purification*; D065309:Atypical Squamous Cells of the Cervix / Q000145:classification / Q000473:pathology / Q000821:virology; D002584:Cervix Uteri / Q000473:pathology / Q000821:virology*; D004279:DNA, Viral / Q000032:analysis*; D055088:Early Detection of Cancer / Q000592:standards; D005260:Female; D061809:Human Papillomavirus DNA Tests; D006801:Humans; D060885:Multiplex Polymerase Chain Reaction; D060787:Neoplasm Grading; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000453:epidemiology / Q000473:pathology / Q000821:virology; D017410:Practice Guidelines as Topic; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction; D056910:Republic of Korea / Q000453:epidemiology; D012307:Risk Factors; D012680:Sensitivity and Specificity; D065310:Squamous Intraepithelial Lesions of the Cervix / Q000175:diagnosis / Q000453:epidemiology / Q000473:pathology / Q000821:virology; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000453:epidemiology / Q000473:pathology / Q000821:virology; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000453:epidemiology / Q000473:pathology / Q000821:virology
chemical_list: D004279:DNA, Viral; D011933:Reagent Kits, Diagnostic