Reliability of the Xpert HPV assay to detect high-risk human papillomavirus DNA in a colposcopy referral population

Philip E. Castle, Katherine M. Smith, Thomas E. Davis, Kathleen M. Schmeler, Daron G. Ferris, Ashlyn H. Savage, Jermaine E. Gray, Mark H. Stoler, Thomas C. Wright, Alex Ferenczy, Mark H. Einstein

Research output: Contribution to journalArticle

21 Scopus citations

Abstract

Objectives: The Xpert HPV Assay (Xpert; Cepheid, Sunnyvale, CA) was developed for the multianalytic GeneXpert platform. Methods: In a colposcopy referral population of 708 women living in the United States, two cervical specimens, A and B, were collected, and both were tested by the Xpert assay for high-risk human papillomavirus (hrHPV) DNA, permitting an evaluation of its test reliability. Specimen B was also tested by Hybrid Capture 2 (hc2; Qiagen, Germantown, MD) and the cobas HPV Test (cobas; Roche Molecular Systems, Pleasanton, CA). Results: The κ and percent agreement for any hrHPV for the two Xpert results were 0.88 and 94.5%, respectively. There was no statistical difference in testing positive on both specimens by Xpert (P = .62). The sensitivity for detection of cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) was 89.0% using specimen A and 90.4% using specimen B for Xpert, 90.4% for cobas, and 81.6% for hc2. Conclusions: The Xpert assay was sensitive and reliable for the detection of hrHPV and the identification of women with CIN2+.

Original languageEnglish (US)
Pages (from-to)126-133
Number of pages8
JournalAmerican Journal of Clinical Pathology
Volume143
Issue number1
DOIs
StatePublished - Jan 2015

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Keywords

  • Microbiology
  • Molecular diagnostics
  • Virology

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

Cite this

Castle, P. E., Smith, K. M., Davis, T. E., Schmeler, K. M., Ferris, D. G., Savage, A. H., Gray, J. E., Stoler, M. H., Wright, T. C., Ferenczy, A., & Einstein, M. H. (2015). Reliability of the Xpert HPV assay to detect high-risk human papillomavirus DNA in a colposcopy referral population. American Journal of Clinical Pathology, 143(1), 126-133. https://doi.org/10.1309/AJCP4Q0NSDHWIZGU