title: Reproducibility of HPV DNA Testing by Hybrid Capture 2 in a Screening Setting.
abstract: Within a large Italian randomized trial on new technologies for cervical cancer screening involving 7 laboratories with different levels of experience, an intralaboratory and interlaboratory quality control program for human papillomavirus (HPV) DNA testing by Hybrid Capture 2 (HC2; Digene, Gaithersburg, MD) was implemented. To monitor the hybridization and detection steps, target samples containing purified, concentration-defined, HPV DNA were introduced in each test run. Only 3 of 1,024 showed a mistake in a positive vs negative classification with a 1 relative light unit (RLU)/positive control specimen (PC) ratio cutoff. To monitor the preanalytic steps (particularly denaturation), blinded specimens (33 collected in PreservCyt (Cytyc, Boxborough, MA) and 36 in Specimen Transport Medium (STM, Digene) were centrally prepared, divided into aliquots, and sent to each laboratory. The multiple-rater scores for negative (<1 RLU/PC), low-positive (1 to <11 RLU/PC), and high-positive (> or =11 RLU/PC) samples, respectively, were 0.91, 0.60, and 0.69 with PreservCyt and 0.93, 0.87, and 0.90 with STM. Our data showed high reliability and reproducibility with HC2, with values higher for STM than ThinPrep (Cytyc) samples.
authors.affiliation: Center for Study and Prevention of Cancer (CSPO), Florence, Italy.
authors.forename: Francesca Maria
authors.initials: FM
authors.lastname: Carozzi
authors.forename: Annarosa
authors.initials: A
authors.lastname: Del Mistro
authors.forename: Massimo
authors.initials: M
authors.lastname: Confortini
authors.forename: Cristina
authors.initials: C
authors.lastname: Sani
authors.forename: Donella
authors.initials: D
authors.lastname: Puliti
authors.forename: Rossana
authors.initials: R
authors.lastname: Trevisan
authors.forename: Laura
authors.initials: L
authors.lastname: De Marco
authors.forename: Anna Gillio
authors.initials: AG
authors.lastname: Tos
authors.forename: Salvatore
authors.initials: S
authors.lastname: Girlando
authors.forename: Paolo Dalla
authors.initials: PD
authors.lastname: Palma
authors.forename: Antonella
authors.initials: A
authors.lastname: Pellegrini
authors.forename: Maria Luisa
authors.initials: ML
authors.lastname: Schiboni
authors.forename: Paola
authors.initials: P
authors.lastname: Crucitti
authors.forename: Paola
authors.initials: P
authors.lastname: Pierotti
authors.forename: Alberta
authors.initials: A
authors.lastname: Vignato
authors.forename: Guglielmo
authors.initials: G
authors.lastname: Ronco
mesh_terms: D000328:Adult; D002986:Clinical Trials as Topic; D004279:DNA, Viral / Q000032:analysis*; D005260:Female; D006801:Humans; D007753:Laboratories; D008875:Middle Aged; D027383:Papillomaviridae / Q000235:genetics / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000175:diagnosis*; D011786:Quality Control; D015203:Reproducibility of Results; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis*; D014626:Vaginal Smears
chemical_list: D004279:DNA, Viral