title: The indicating FTA elute cartridge a solid sample carrier to detect high-risk HPV and high-grade cervical lesions.
abstract: The clinically validated high-risk human papillomavirus (hrHPV) Hybrid Capture 2 (HC2) and GP5+/6+-PCR assays were analyzed on an Indicating FTA Elute cartridge (FTA cartridge). The FTA cartridge is a solid dry carrier that allows safe transport of cervical samples. FTA cartridge samples were compared with liquid-based samples for hrHPV and high-grade cervical intraepithelial neoplasia (CIN) detection. One cervical sample was collected in a liquid-based medium, and one was applied to the FTA cartridge. DNA was eluted directly from the FTA cartridge by a simple elution step. HC2 and GP5+/6+-PCR assays were performed on both the liquid-based and the FTA-eluted DNA of 88 women. Overall agreement between FTA and liquid-based samples for the presence of hrHPV was 90.9% with GP5+/6+-PCR and 77.3% with HC2. The sensitivity for high-grade CIN of hrHPV testing on the FTA cartridges was 84.6% with GP5+/6+-PCR and only 53.8% with HC2. By comparison, these sensitivities on liquid-based samples were 92.3% and 100% for GP5+/6+-PCR and HC2, respectively. Therefore, the FTA cartridge shows reasonably good overall agreement for hrHPV detection with liquid-based media when using GP5+/6+-PCR but not HC2 testing. Even with GP5+/6+-PCR, the FTA cartridge is not yet capable of detecting all high-grade CIN lesions.
authors.affiliation: Department of Obstetrics and Gynecology, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands. r.debie@obgyn.umcn.nl
authors.forename: Roosmarie P
authors.initials: RP
authors.lastname: de Bie
authors.forename: Channa E
authors.initials: CE
authors.lastname: Schmeink
authors.forename: Judith M J E
authors.initials: JM
authors.lastname: Bakkers
authors.forename: Peter J F
authors.initials: PJ
authors.lastname: Snijders
authors.forename: Wim G V
authors.initials: WG
authors.lastname: Quint
authors.forename: Leon F A G
authors.initials: LF
authors.lastname: Massuger
authors.forename: Ruud L M
authors.initials: RL
authors.lastname: Bekkers
authors.forename: Willem J G
authors.initials: WJ
authors.lastname: Melchers
mesh_terms: D000328:Adult; D000368:Aged; D052685:Alphapapillomavirus; D005260:Female; D006801:Humans; D008875:Middle Aged; D025202:Molecular Diagnostic Techniques / Q000379:methods*; D030361:Papillomavirus Infections / Q000175:diagnosis*; D011933:Reagent Kits, Diagnostic; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D014759:Viral Envelope Proteins / Q000235:genetics; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis*
chemical_list: D011933:Reagent Kits, Diagnostic; D014759:Viral Envelope Proteins