Test performance comparison of inform HPV and Hybrid capture 2 high-risk HPV DNA tests using the SurePath liquid-based Pap test as the collection method

Sharon Davis-Devine, Sarah J. Day, Gregory G. Freund

Research output: Contribution to journalArticlepeer-review

Abstract

No US Food and Drug Administration-approved method is available to test for human papillomavirus (HPV) DNA in the SurePath liquid-based Papanicolaou (Pap) test (TriPath Care Technologies, Burlington, NC). We compared the performance characteristics of Inform HPV (Ventana Medical Systems, Tucson, AZ) and Hybrid Capture 2 (HC2; Digene, Gaithersburg, MD) using SurePath for collection. The study included samples from 102 women, aged 18 to 60 years, who underwent a SurePath Pap test immediately before colposcopy and cervical biopsy. Each SurePath specimen was processed additionally for Inform HPV and HC2. Performance characteristics were determined by using the cervical biopsy as the "gold standard." The SurePath, Inform HPV, and HC2 correctly identified high-grade squamous intraepithelial lesions (HSILs) in 15 (94%) of 16, 6 (38%) of 16, and 14 (93%) of 15 cases, respectively. When only SurePath samples with a diagnosis of atypical glandular and/or squamous cells were examined, Inform HPV and HC2 correctly identified HSIL in 19 (43%) of 44 and 45 (100%) of 45 cases, respectively. When SurePath is used for collection, Inform HPV lacks sufficient sensitivity to detect HSIL reliably.

Original languageEnglish (US)
Pages (from-to)24-30
Number of pages7
JournalAmerican journal of clinical pathology
Volume124
Issue number1
DOIs
StatePublished - Jul 2005

Keywords

  • HPV testing
  • Human papillomavirus
  • Hybrid capture 2
  • Inform HPV
  • SurePath liquid-based Pap test

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

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