title: Novaprep(®) Vial Test is a suitable liquid-based cytology medium for high risk human papillomavirus testing by Hybrid Capture 2.
abstract: BACKGROUND
  Liquid-based cytology (LBC) for cervical cancer screening presents the advantage that cytological and virological investigations can be undertaken from the same specimen. Nevertheless, the fixative may alter DNA integrity and the sample may be inadequate for HPV DNA detection. The Novaprep(®) Vial Test (NVT) (Novacyt, Vélizy-Villacoublay, France) is a new device dedicated to LBC which permits an automated cell spreading over slides and an automated cell sampling for molecular analyses.
  
  
  OBJECTIVE
  To determine whether the NVT was suitable for high risk (HR) HPV DNA detection with the Hybrid Capture 2 (HC2) assay (Qiagen, Courtaboeuf, France).
  
  
  METHODS
  Two cervical specimens were harvested. The first sample was taken with a Rovers Cervex Brush (Therapak Corporation, Buford, USA) placed in the NVT and the second sample was taken with a DNAPAP cervical sampler placed in the Specimen Transport Medium (STM) (Qiagen). This last sample served as gold standard for HPV detection. NVT and STM samples were analyzed for HR HPV DNA with HC2 assay.
  
  
  RESULTS
  One hundred and thirty-one samples stored in NVT and STM were analyzed. The overall HC2 positivity determined from the 99 samples classified as satisfactory for cellularity (>5000 cells/slide) was 84% whatever the collection medium was. Agreement for HPV detection between NVT and STM was 94%, with a Kappa of 0.78. Moreover, we noted that HC2 values obtained from NVT samples were correlated to those obtained from STM samples.
  
  
  CONCLUSIONS
  The Novaprep(®) Vial Test adequately preserves HPV DNA and is suitable for HPV testing with HC2 if cellularity is satisfactory.
authors.affiliation: Univ Franche-Comte, EA3181, Laboratoire de Biologie Cellulaire et Moléculaire, IFR133, Besancon, France. jean_luc.pretet@univ-fcomte.fr
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Prétet
authors.forename: Chrystelle
authors.initials: C
authors.lastname: Vidal
authors.forename: Karine
authors.initials: K
authors.lastname: Le Bail Carval
authors.forename: Rajeev
authors.initials: R
authors.lastname: Ramanah
authors.forename: Xavier
authors.initials: X
authors.lastname: Carcopino
authors.forename: Isabelle
authors.initials: I
authors.lastname: Cartier
authors.forename: Eric
authors.initials: E
authors.lastname: Labouyrie
authors.forename: Bernadette
authors.initials: B
authors.lastname: Kantelip
authors.forename: Sylviane
authors.initials: S
authors.lastname: Coumes-Marquet
authors.forename: Didier
authors.initials: D
authors.lastname: Riethmuller
authors.forename: Christiane
authors.initials: C
authors.lastname: Mougin
mesh_terms: D000328:Adult; D001331:Automation / Q000379:methods; D003470:Culture Media / Q000737:chemistry; D003584:Cytological Techniques / Q000379:methods*; D005260:Female; D005602:France; D006801:Humans; D009693:Nucleic Acid Hybridization / Q000379:methods*; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis* / Q000821:virology; D014481:United States; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000821:virology; D014773:Virology / Q000379:methods*
chemical_list: D003470:Culture Media