title: Clinical validation of Anyplex™ II HPV HR Detection according to the guidelines for HPV test requirements for cervical cancer screening.
abstract: BACKGROUND
  Anyplex™ II HPV HR Detection (Seegene, Seoul, Korea) is a multiplex real-time PCR using tagging oligonucleotide cleavage and extension (TOCE) technology for simultaneous detection and genotyping of 14 high-risk (HR) HPV types, including HPV16 and HPV18.
  
  
  OBJECTIVE
  To evaluate whether the clinical performance and reproducibility of Anyplex™ II HPV HR Detection meet the international consensus guidelines for HPV test requirements for cervical cancer screening [1].
  
  
  METHODS
  The clinical performance of Anyplex™ II HPV HR Detection for detecting cervical intraepithelial neoplasia grade 2 or worse (CIN2+) was determined relative to that of the reference assay, i.e., HR HPV GP5+/6+-PCR-EIA, by analysis of a total of 879 cervical liquid based cytology (LBC) specimens from a screening population, of which 60 were from women with CIN2+. The intra-laboratory reproducibility and inter-laboratory agreement were determined on 509 LBC samples, of which 172 were positive by the reference assay.
  
  
  RESULTS
  Anyplex™ II HPV HR Detection showed a clinical sensitivity for CIN2+ of 98.3% (59/60; 95% CI: 89.1-99.8) and a clinical specificity for CIN2+ of 93.6% (764/816; 95% CI: 89.8-96.1). The clinical sensitivity and specificity were non-inferior to those of HR HPV GP5+/6+-PCR-EIA (non-inferiority score test: P=0.005 and P=0.023, respectively). Both intra-laboratory reproducibility (96.8%; 95% CI: 95.3-98.1; kappa value of 0.93) and inter-laboratory agreement (96.0%; 95% CI: 94.3-97.4; kappa value of 0.91) were high.
  
  
  CONCLUSIONS
  Anyplex™ II HPV HR Detection performs clinically non-inferior to HR HPV GP5+/6+-PCR-EIA. Anyplex™ II HPV HR Detection complies with international consensus validation metrics for HPV DNA tests for cervical cancer screening [1].
authors.affiliation: Self-screen B.V., Amsterdam, The Netherlands.
authors.forename: A T
authors.initials: AT
authors.lastname: Hesselink
authors.affiliation: Institute of Microbiology, Centre Hospitalier Universitaire Vaudois (CHUV) and University of Lausanne, Lausanne, Switzerland.
authors.forename: R
authors.initials: R
authors.lastname: Sahli
authors.affiliation: Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: J
authors.initials: J
authors.lastname: Berkhof
authors.affiliation: Department of Pathology, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: P J F
authors.initials: PJ
authors.lastname: Snijders
authors.affiliation: Self-screen B.V., Amsterdam, The Netherlands.
authors.forename: M L
authors.initials: ML
authors.lastname: van der Salm
authors.affiliation: Department of Pathology, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: D
authors.initials: D
authors.lastname: Agard
authors.affiliation: Department of Pathology, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: M C G
authors.initials: MC
authors.lastname: Bleeker
authors.affiliation: Department of Pathology, VU University Medical Center, Amsterdam, The Netherlands. Electronic address: dam.heideman@vumc.nl.
authors.forename: D A M
authors.initials: DA
authors.lastname: Heideman
mesh_terms: D000328:Adult; D052685:Alphapapillomavirus / Q000235:genetics / Q000302:isolation & purification*; D003127:Colposcopy; D055088:Early Detection of Cancer / Q000379:methods; D005260:Female; D005838:Genotype; D006801:Humans; D008403:Mass Screening; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000517:prevention & control / Q000821:virology; D011247:Pregnancy; D011933:Reagent Kits, Diagnostic; D060888:Real-Time Polymerase Chain Reaction; D015203:Reproducibility of Results; D056910:Republic of Korea; D012680:Sensitivity and Specificity; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000517:prevention & control* / Q000821:virology; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000517:prevention & control* / Q000821:virology
chemical_list: D011933:Reagent Kits, Diagnostic
keywords: CIN2/3; HPV; Primary cervical cancer screening; Test requirements