title: Comparison of the Anyplex II HPV28 assay with the Hybrid Capture 2 assay for the detection of HPV infection.
abstract: BACKGROUND
  Human papillomavirus (HPV) testing is an important part of cervical cancer screening and management of women with abnormal cytology results. The Hybrid Capture 2 (HC2) has been recommended for use as a reference test.
  
  
  OBJECTIVE
  To evaluate a new real-time PCR assay (Anyplex II HPV28) for detecting high risk (HR) HPV and to compare it to the HC2. In addition, we compared the genotyping results of the Anyplex II HPV28 to those of sequencing analysis.
  
  
  METHODS
  A total of 1114 cervical swab specimens were consecutively obtained from a single healthcare center. We submitted all specimens for HPV detection with Anyplex II HPV28 and HC2, then analyzed the discordant results using multiplex PCR followed by direct sequencing.
  
  
  RESULTS
  HC2 detected 72 (6.5%) cases with HR HPV, while Anyplex II HPV28 identified 138 (12.4%) cases. The overall agreement rate was 91.4% (1018/1114) of cases. Discordant results between these two assays were observed in 96 cases; 15 were positive only by HC2, and 81 were positive only by Anyplex II HPV28. Sequencing analyses performed in 80 cases of discordant results revealed 11 false-positive, and 67 false-negative results using HC2 tests and two false-positive results using Anyplex II HPV28.
  
  
  CONCLUSIONS
  The Anyplex II HPV28 assay is analytically more sensitive in the detection of the 13 HR types represented by the HC2 assay and exhibited a higher concordance with comprehensive genotyping based on the sequencing analysis, and it could be used as a laboratory testing method for identifying HPV genotypes.
authors.affiliation: Department of Laboratory Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.
authors.forename: Min-Jung
authors.initials: MJ
authors.lastname: Kwon
authors.affiliation: Seegene Institute of Life Sciences, Seoul, South Korea.
authors.forename: Kyoung Ho
authors.initials: KH
authors.lastname: Roh
authors.affiliation: Department of Laboratory Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.
authors.forename: Hyosoon
authors.initials: H
authors.lastname: Park
authors.affiliation: Department of Laboratory Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: drwhy@hanmail.net.
authors.forename: Hee-Yeon
authors.initials: HY
authors.lastname: Woo
mesh_terms: D000328:Adult; D000368:Aged; D055088:Early Detection of Cancer / Q000379:methods; D005260:Female; D060005:Genotyping Techniques / Q000379:methods; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D027383:Papillomaviridae / Q000145:classification* / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D060888:Real-Time Polymerase Chain Reaction / Q000379:methods; D012680:Sensitivity and Specificity; D014773:Virology / Q000379:methods*; D055815:Young Adult
keywords: Anyplex II HPV28; Genotypes; HC2; Human papilloma virus