Self-collected Papanicolaou tests in the United States market: more questions than answers

Paul N. Staats, Christine N. Booth, Dorothy L. Rosenthal, Barbara A. Crothers

Research output: Contribution to journalReview articlepeer-review

Abstract

The United States Food and Drug Administration held a public hearing in January 2018 to consider how it should evaluate a self-collection device for cervical cytology. Although no such device has been approved for use in the US market, the implications for patients and cytologists could be both sweeping and complex. Herein, the existing literature basis for self-collected Papanicolaou testing is reviewed, and some questions raised by this testing are considered. Questions include: what would be the value to patients; how effective could self-collected Papanicolaou tests be; how might ordering and collection work; what are the unique pre-analytic, analytic, and post-analytic challenges of self-collected Papanicolaou testing; and what effect might self-collection have on cervical cancer rates?

Original languageEnglish (US)
Pages (from-to)342-351
Number of pages10
JournalJournal of the American Society of Cytopathology
Volume8
Issue number6
DOIs
StatePublished - Nov 1 2019

Keywords

  • Cancer screening
  • Cervical cancer
  • Gynecologic cytology
  • Pap test
  • Papanicolaou test
  • Self-collection

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

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