A review of the FDA-approved molecular testing platforms for human papillomavirus

Katrina L. Salazar, Daniel J. Duhon, Randall Olsen, Michael Thrall

Research output: Contribution to journalReview articlepeer-review

38 Scopus citations


The advent of US Food and Drug Administration (FDA)-approved molecular testing for human papillomavirus (HPV) has resulted in a dramatic shift from cytological testing alone to a combination of cytology and molecular testing for primary HPV screening. HPV testing has quickly become an essential component of daily practice in most laboratories and clinical practices. Although the principle of HPV testing is now familiar, it is important to understand the mechanisms behind these platforms in order to properly interpret the results and understand the limits of each method. HPV tests are more automated and reproducible than cytology, but are by no means perfect. None of these platforms will identify every HSIL/CIN2+ or cancer. This fact must be kept in mind when correlating the results of HPV testing with cytology or biopsy findings. The goal of this paper is to review the FDA- approved molecular testing platforms for HPV, including methodology, limitations, and specifications. The concordance between the platforms will also be discussed. Package inserts of the 5 FDA- approved molecular testing platforms for HPV, as well as a literature review of the platforms, were reviewed and assimilated into the article. Due to the multiple modalities available for detection of hrHPV, the concordance between these assays becomes important. Prior publications have compared HC2, Cervista, cobas, and Aptima, with most studies comparing to HC2 because it is considered the reference standard. With the newly approved BD platform, concordance studies were reviewed as well.

Original languageEnglish (US)
Pages (from-to)284-292
Number of pages9
JournalJournal of the American Society of Cytopathology
Issue number5
StatePublished - Sep 1 2019


  • FDA-approved
  • Human Papillomavirus
  • Molecular
  • Review
  • Testing

ASJC Scopus subject areas

  • Pathology and Forensic Medicine


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