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Diagnostics
Original research
Rapid point-of-care testing for COVID-19: quality of supportive information for lateral flow serology assays
  1. Patrick Kierkegaard1,2,
  2. Anna McLister1,
  3. Peter Buckle1
  1. 1NIHR London In Vitro Diagnostics Co-operative, Department of Surgery and Cancer, Imperial College London, London, UK
  2. 2CRUK Convergence Science Centre, Institute of Cancer Research & Imperial College London, London, UK
  1. Correspondence to Dr Patrick Kierkegaard; p.kierkegaard{at}imperial.ac.uk

Abstract

Objective There is a lack of evidence addressing several important human factors questions pertaining to the quality of supportive information provided by commercial manufacturers that can affect the adoption and use of lateral flow serology assays in practice. We aimed to: (1) identify and assess the quality of information that commercial manufacturers provided for their point-of-care tests (POCTs) and (2) examine the implications of these findings on real-world settings.

Design We used a content analysis methodology in two stages to systematically, code and analyse textual data from documents of commercial manufacturers. A deductive approach was applied using a coding guide based on the validated Point-of-Care Key Evidence Tool (POCKET) multidimensional checklist. An inductive approach was used to identify new patterns or themes generated from our textual analysis.

Setting Publicly available supportive information documents by commercial manufacturers for lateral flow serology, were identified and gathered from online searches.

Participants Supportive information documents retrieved from online searches over 3 months (March 2020 to June 2020).

Results A total of 79 POCTs were identified that met the study inclusion criteria. Using the POCKET coding guide, we found that the quality of information varied significantly between the manufacturers and was often lacking in detail. Our inductive approach further examined these topics and found that several statements were vague and that significant variations in the level of details existed between manufacturers.

Conclusions This study revealed significant concerns surrounding the supportive information reported by manufacturers for lateral flow serology assays. Information transparency was poor and human factor issues were not properly addressed to mitigate the risk of improper device use, although it should be noted that the results of our study are limited by the data that manufactures were prepared to disclose. Overall, commercial manufacturers should improve the quality and value of information presented in their supporting documentation.

  • COVID-19
  • public health
  • infectious diseases
  • health services administration & management
http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2020-047163

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    Footnotes

    • Contributors PK drafted the first iteration of the manuscript. AM contributed to the manuscript preparation and editing. PB provided valuable feedback and contributed to the editing. All authors reviewed the final version of the manuscript for content and contributed to the conclusions of this manuscript.

    • Funding This research was supported by the National Institute of Health Research (NIHR) In-Vitro Diagnostic Co-operative London at Imperial College Healthcare NHS Trust. The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR or the Department of Health. Award/grant number: N/A.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval The study did not involve active treatment of human participants, ethics review and approval was not necessary because all the material was publicly available or voluntarily provided by the manufacturers or authorised distributors.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available upon reasonable request. Data are available upon reasonable request.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.