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Reproducibility of HPV DNA Testing by Hybrid Capture 2 in a Screening Setting
Intralaboratory and Interlaboratory Quality Control in Seven Laboratories Participating in the Same Clinical Trial

Francesca Maria Carozzi PhD, Annarosa Del Mistro MD, Massimo Confortini PhD, Cristina Sani MD, Donella Puliti MD, Rossana Trevisan, Laura De Marco PhD, Anna Gillio Tos PhD, Salvatore Girlando MD, Paolo Dalla Palma PhD, Antonella Pellegrini PhD, Maria Luisa Schiboni PhD, Paola Crucitti MD, Paola Pierotti MD, Alberta Vignato MD, Guglielmo Ronco PhD
DOI: http://dx.doi.org/10.1309/84E5WHJQHK83BGQD 716-721 First published online: 1 November 2005

Abstract

Within a large Italian randomized trial on new technologies for cervical canc+er 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 κ scores for negative (<1 RLU/PC), low-positive (1 to <11 RLU/PC), and high-positive (≥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 κ values higher for STM than ThinPrep (Cytyc) samples.

Key Words:
  • Screening
  • Cervical cancer
  • Human papillomavirus
  • HPV
  • Hybrid Capture 2
  • HC2
  • Quality control
  • Reproducibility
  • Accuracy

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