Article Text

Original research
Information given by websites selling home self-sampling COVID-19 tests: an analysis of accuracy and completeness
  1. Sian Taylor-Phillips1,2,
  2. Sarah Berhane2,3,
  3. Alice J Sitch2,3,
  4. Karoline Freeman1,2,
  5. Malcolm James Price2,3,
  6. Clare Davenport2,3,
  7. Julia Geppert1,
  8. Isobel M Harris2,
  9. Osemeke Osokogu1,
  10. Magdalena Skrybant2,4,
  11. Jonathan J Deeks2,3
  1. 1 Warwick Medical School, University of Warwick, Coventry, UK
  2. 2 Institute of Applied Health Research, University of Birmingham, Birmingham, UK
  3. 3 NIHR Birmingham Biomedical Research Centre, University Hospitals Birmingham NHS Foundation Trust and University of Birmingham, Birmingham, UK
  4. 4 NIHR Applied Research Collaboration West Midlands, University of Warwick, Coventry, UK
  1. Correspondence to Dr Sian Taylor-Phillips; s.taylor-phillips{at}warwick.ac.uk

Abstract

Objectives To assess the accuracy and completeness of information provided by websites selling home self-sampling and testing kits for COVID-19.

Design Cross-sectional observational study.

Setting All websites (n=27) selling direct to user home self-sampling and testing kits for COVID-19 (41 tests) in the UK (39 tests) and USA (two tests) identified by a website search on 23 May 2020.

Main outcome measures Thirteen predefined basic information items to communicate to a user, including who should be tested, when and how testing should be done, test accuracy, and interpretation of results.

Results Many websites did not provide the name or manufacturer of the test (32/41; 78%), when to use the test (10/41; 24%), test accuracy (12/41; 29%), and how to interpret results (21/41; 51%). Sensitivity and specificity were the most commonly reported test accuracy measures (either reported for 27/41 [66%] tests): we could only link these figures to manufacturers’ documents or publications for four (10%) tests. Predictive values, most relevant to users, were rarely reported (five [12%] tests reported positive predictive values). For molecular virus tests, 9/23 (39%) websites explained that test positives should self-isolate, and 8/23 (35%) explained that test negatives may still have the disease. For antibody tests, 12/18 (67%) websites explained that testing positive does not necessarily infer immunity from future infection. Seven (39%) websites selling antibody tests claimed the test had a CE mark, when they were for a different intended use (venous blood rather than finger-prick samples).

Conclusions At the point of online purchase of home self-sampling COVID-19 tests, users in the UK are provided with incomplete, and, in some cases, misleading information on test accuracy, intended use, and test interpretation. Best practice guidance for communication about tests to the public should be developed and enforced for online sales of COVID-19 tests.

  • health policy
  • public health
  • public health
  • infectious diseases
  • COVID-19
https://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Twitter @deeksj

  • Contributors STP, SB, AJS, KF, MJP, CD, JG, IMH, OO, MS, and JJD contributed to the conception of the work and interpretation of the findings. OO and JG performed the Google searches. STP, SB, KF, JG, OO, IMH, and MJP extracted the data. STP, AJS, MJP, and CD undertook the analysis and drafted the manuscript. STP, SB, AJS, KF, MJP, CD, JG, IMH, OO, MS, and JJD critically revised the manuscript and approved the final version. STP acts as guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

  • Funding This paper presents independent research supported by the NIHR Birmingham Biomedical Research Centre at the University Hospitals Birmingham NHS Foundation Trust and the University of Birmingham. T-P is supported by an NIHR Career Development Fellowship (CDF-2016- 09-018). MS is supported by the National Institute for Health Research (NIHR) Applied Research Collaboration (ARC) West Midlands. KF is funded by the NIHR through a doctoral research fellowship.

  • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care.

  • Competing interests MS reports grants from NIHR Applied Research Collaboration WM; AJS, SB, MP, CD, and JD report funding and support from NIHR Birmingham Biomedical Research Centre.

  • Patient consent for publication Not required.

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

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information. No additional data available.

  • 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.

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