Self-collected Papanicolaou tests in the United States market: more questions than answers.
Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland. Electronic address: [email protected]
Department of Pathology, Cleveland Clinic, Cleveland, Ohio.
Department of Pathology/Cytopathology, Johns Hopkins Medicine, Baltimore, Maryland.
Breast, Gynecology and Cytopathology Service, Joint Pathology Center, Silver Spring, Maryland.
- Published Article
Journal of the American Society of Cytopathology
- Publication Date
Jan 01, 2019
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? Copyright © 2019 American Society of Cytopathology. All rights reserved.
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This record was last updated on 07/13/2020 and may not reflect the most current and accurate biomedical/scientific data available from NLM.
The corresponding record at NLM can be accessed at https://www.ncbi.nlm.nih.gov/pubmed/31257176