Can untrained persons correctly perform and interpret the results of SARS-CoV-2 rapid antigen detection tests (RADT), and can performance be optimized?
In this cross-sectional study of 278 participants self-performing SARS-CoV-2 RADT in an intended-use setting, the accuracy of RADT interpretation was poor when the manufacturer’s instructions were used. A modified quick reference guide was associated with significantly better user performance.
These findings suggest that longitudinal mass RADT testing for SARS-CoV-2 could be accurately self-performed in an intended-use setting but there are potential interventions to optimize performance.
Longitudinal mass testing using rapid antigen detection tests (RADT) for serial screening of asymptomatic persons has been proposed for preventing SARS-CoV-2 community transmission. The feasibility of this strategy relies on accurate self-testing.
To quantify the adequacy of serial self-performed SARS-CoV-2 RADT testing in the workplace, in terms of the frequency of correct execution of procedural steps and accurate interpretation of the range of possible RADT results.
Design, Setting, and Participants
This prospective repeated cross-sectional study was performed from July to October 2021 at businesses with at least 2 active cases of SARS-CoV-2 infection in Montreal, Canada. Participants included untrained persons in their workplace, not meeting Public Health quarantine criteria (ie, required quarantine for 10 days after a moderate-risk contact with someone infected with SARS-CoV-2). Interpretation and performance were compared between participants who received instructions provided by the manufacturer vs those who received modified instructions that were informed by the most frequent or most critical errors we observed. Data were analyzed from October to November 2021.
RADT testing using a modified quick reference guide compared with the original manufacturer’s instructions.
Main Outcomes and Measures
The main outcome was the difference in correctly interpreted RADT results. Secondary outcomes included difference in proportions of correctly performed procedural steps. Additional analyses, assessed among participants with 2 self-testing visits, compared the second self-test visit with the first self-test visit using the same measures.
Overall, 1892 tests were performed among 647 participants, of whom 278 participants (median [IQR] age, 43 [31-55] years; 156 [56.1%] men) had at least 1 self-testing visit. For self-test visit 1, significantly better accuracy in test interpretation was observed among participants using the modified quick reference guide than those using the manufacturer’s instructions for reading results that were weak positive (64 of 115 participants [55.6%] vs 20 of 163 participants [12.3%]; difference, 43.3 [95% CI, 33.0-53.8] percentage points), positive (103 of 115 participants [89.6%] vs 84 of 163 participants [51.5%]; difference, 38.1 [95% CI, 28.5-47.5] percentage points), strong positive (219 of 229 participants [95.6%] vs 274 of 326 participants [84.0%]; difference, 11.6 [95% CI, 6.8-16.3] percentage points), and invalid (200 of 229 participants [87.3%] vs 252 of 326 participants [77.3%]; difference, 10.0 [95% CI, 3.8-16.3] percentage points). Use of the modified guide was associated with improvements on self-test visit 2 for results that were weak positive (difference, 15.4 [95% CI, 0.7-30.1] percentage points), positive (difference, 19.0 [95% CI, 7.2-30.9] percentage points), and invalid (difference, 8.0 [95% CI, 0.8-15.4] percentage points). For procedural steps identified as critical for test validity, adherence to procedural testing steps did not differ meaningfully according to instructions provided or reader experience.
Conclusions and Relevance
In this cross-sectional study of self-performed SARS-CoV-2 RADT in an intended-use setting, a modified quick reference guide was associated with significantly improved accuracy in RADT interpretations.
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: March 18, 2022.
Published: May 6, 2022. doi:10.1001/jamanetworkopen.2022.10559
Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2022 Papenburg J et al. JAMA Network Open.
Corresponding Author: Cédric P. Yansouni, MD, J.D. MacLean Centre for Tropical Diseases, McGill University Health Centre, 1001 Décarie Blvd, Room EM3.3242, Montreal, Quebec H4A 3J1, Canada (firstname.lastname@example.org).
Author Contributions: Dr Yansouni had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Papenburg, Campbell, Cheng, Menzies, Yansouni.
Acquisition, analysis, or interpretation of data: Papenburg, Campbell, Caya, Dion, Corsini, Cheng, Yansouni.
Drafting of the manuscript: Papenburg, Caya, Yansouni.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Campbell, Caya, Cheng, Yansouni.
Obtained funding: Papenburg, Yansouni.
Administrative, technical, or material support: Caya, Dion, Corsini, Yansouni.
Supervision: Papenburg, Yansouni.
Conflict of Interest Disclosures: Dr Papenburg reported receiving grants from AbbVie, Merck, Sanofi, and MedImmune; personal fees from AbbVie, Seegene, AstraZeneca, and Merck; and serving as an advisor to the Canadian Federal COVID-19 Immunity Task Force outside the submitted work. Dr Campbell reported serving as a consultant for the COVID-19 Immunity Task Force in Canada and World Bank. Dr Cheng reported receiving personal fees from GEn1E Lifesciences, Nomic Bio, and AstraZeneca; serving as cofounder of Kanvas Biosciences; and having patents for detecting tissue damage, graft vs host disease, and infections using cell-free DNA profiling pending, and a patent for assessing the severity and progression of SARS-CoV-2 infections using cell-free DNA pending outside the submitted work. Dr Yansouni reported receiving personal fees from Medicago and World Health Organization and serving as an advisor to the Canadian Federal COVID-19 Immunity Task Force outside the submitted work. No other disclosures were reported.
Funding/Support: This work was funded by grants from the Québec Ministry of Health and Social Services and the Trottier Family Foundation. Dr Yansouni holds a “Chercheur-boursier clinicien” career award from the Fonds de recherche du Québec–Santé.
Role of the Funder/Sponsor: The funders gave feedback on the design and conduct of the study but had no role in data collection, management, analysis, or interpretation of the data; preparation, review or approval of the manuscript; or decision to submit the manuscript for publication.
Additional Contributions: The Santé au Travail Group of the Montreal Public Health Department and 18 employees in the field and data-entry teams contributed greatly to the accomplishment of the study.
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