title: Validation of Novaprep(®) HQ+ liquid-based cytology medium for high-risk human papillomavirus detection by hc2.
abstract: BACKGROUND
  Preanalytical conditions determine the reliability and validity of bioassays. Therefore, the analytic performances of biological tests need to be determined when preanalytical steps differ from those recommended by the manufacturer. The objective of the study was to assess the analytic performance of the hc2 test for the detection of high-risk HPV DNA from cells stored in the new Novaprep® HQ+ medium.
  
  
  METHODS
  Repeatability, reproducibility, method comparison and stability (-20 °C, +4 °C, +20 °C and +40 °C up to six months) were evaluated from HPV16 and HPV18 positive cell lines diluted in the Novaprep® HQ+ medium and the reference Specimen Transport Medium (STM). A series of cervical samples with atypical squamous cells of undetermined significance (ASC-US) cytology and stored in the Novaprep® HQ+ medium was also tested.
  
  
  RESULTS
  Coefficients of variation for repeatability and reproducibility were less than 8 %. Method comparison showed perfect agreement in hc2 results when the HPV-positive cells were diluted in HQ+ and reference media. Stability experiments demonstrated that the storage conditions did not alter the hc2 test results. Furthermore, clinical samples were adequately preserved for hc2 testing.
  
  
  CONCLUSIONS
  Overall, our data show that the new Novaprep HQ+ medium is suitable for high-risk HPV testing by hc2.
authors.affiliation: COMUE UBFC, Univ Franche-Comte, F-25000 Besancon, France ; CHRU Besancon, F-25000 Besancon, France ; EA 3181, LabEx LipSTIC ANR-11-LABX-0021, FED4234, F-25000 Besancon, France.
authors.forename: David
authors.initials: D
authors.lastname: Guenat
authors.affiliation: COMUE UBFC, Univ Franche-Comte, F-25000 Besancon, France ; EA 3181, LabEx LipSTIC ANR-11-LABX-0021, FED4234, F-25000 Besancon, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Launay
authors.affiliation: COMUE UBFC, Univ Franche-Comte, F-25000 Besancon, France ; CHRU Besancon, F-25000 Besancon, France ; EA 3181, LabEx LipSTIC ANR-11-LABX-0021, FED4234, F-25000 Besancon, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Riethmuller
authors.affiliation: COMUE UBFC, Univ Franche-Comte, F-25000 Besancon, France ; CHRU Besancon, F-25000 Besancon, France ; EA 3181, LabEx LipSTIC ANR-11-LABX-0021, FED4234, F-25000 Besancon, France.
authors.forename: Christiane
authors.initials: C
authors.lastname: Mougin
authors.affiliation: COMUE UBFC, Univ Franche-Comte, F-25000 Besancon, France ; CHRU Besancon, F-25000 Besancon, France ; EA 3181, LabEx LipSTIC ANR-11-LABX-0021, FED4234, F-25000 Besancon, France ; Inserm CIC 1431, F-25000 Besancon, France ; Laboratoire de Biologie Cellulaire et Moléculaire, Centre Hospitalier Régional Universitaire, Boulevard A Fleming, 25030 Besançon cedex, France.
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Prétet
keywords: HPV testing; Hybrid capture 2; Liquid based cytology; Papillomavirus; Validation