Breaking Through the Barrier: Regulatory Considerations Relevant to Ambient Mass Spectrometry at the Bedside

Michael Woolman; Lauren Katz; Alessandra Tata; Sankha S Basu; Arash Zarrine-Afsar

doi:10.1016/j.cll.2021.03.004

Breaking Through the Barrier: Regulatory Considerations Relevant to Ambient Mass Spectrometry at the Bedside

Clin Lab Med. 2021 Jun;41(2):221-246. doi: 10.1016/j.cll.2021.03.004. Epub 2021 Apr 24.

Authors

Michael Woolman¹, Lauren Katz¹, Alessandra Tata², Sankha S Basu³, Arash Zarrine-Afsar⁴

Affiliations

¹ Techna Institute for the Advancement of Technology for Health, University Health Network, 100 College Street, Toronto, Ontario M5G 1P5, Canada; Department of Medical Biophysics, University of Toronto, 101 College Street, Toronto, Ontario M5G 1L7, Canada.
² Laboratorio di Chimica Sperimentale, Istituto Zooprofilattico delle Venezie, Viale Fiume 78, 36100 Vicenza, Italy.
³ Department of Pathology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.
⁴ Techna Institute for the Advancement of Technology for Health, University Health Network, 100 College Street, Toronto, Ontario M5G 1P5, Canada; Department of Medical Biophysics, University of Toronto, 101 College Street, Toronto, Ontario M5G 1L7, Canada; Department of Surgery, University of Toronto, 149 College Street, Toronto, Ontario M5T 1P5, Canada; Keenan Research Center for Biomedical Science & the Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond Street, Toronto, Ontario M5B 1W8, Canada. Electronic address: arash.zarrine.afsar@utoronto.ca.

PMID: 34020761
DOI: 10.1016/j.cll.2021.03.004

Abstract

Rapid characterization of tissue disorder using ambient mass spectrometry (MS) techniques, requiring little to no preanalytical preparations of sampled tissues, has been shown using a variety of ion sources and with many disease classes. A brief overview of ambient MS in clinical applications, the state of the art in regulatory affairs, and recommendations to facilitate adoption for use at the bedside are presented. Unique challenges in the validation of untargeted MS methods and additional safety and compliance requirements for deployment within a clinical setting are further discussed. Development of a harmonized validation strategy for ambient MS methods is emphasized.

Keywords: Ambient mass spectrometry; Mass spectrometry in the clinic; Regulatory considerations; Untargeted mass spectrometry analysis.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Mass Spectrometry*

Grants and funding

CIHR/Canada