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. 2022 Jan 4;6(1):e32564.
doi: 10.2196/32564.

A Telemedicine-Guided Self-Collection Approach for PCR-Based SARS-CoV-2 Testing: Comparative Study

Silvia Würstle #  1 , Johanna Erber #  1 , Michael Hanselmann  2 , Dieter Hoffmann  3 , Stanislas Werfel  4 , Svenja Hering  3 , Simon Weidlich  1 , Jochen Schneider  1 , Ralf Franke  5 , Michael Maier  5 , Andreas G Henkel  6 , Roland M Schmid  1 , Ulrike Protzer  3   7 , Michael Laxy #  2 , Christoph D Spinner #  1   7
Affiliations

A Telemedicine-Guided Self-Collection Approach for PCR-Based SARS-CoV-2 Testing: Comparative Study

Silvia Würstle et al. JMIR Form Res. .

Abstract

Background: Large-scale, polymerase chain reaction (PCR)-based SARS-CoV-2 testing is expensive, resource intensive, and time consuming. A self-collection approach is a probable alternative; however, its feasibility, cost, and ability to prevent infections need to be evaluated.

Objective: This study aims to compare an innovative self-collection approach with a regular SARS-CoV-2 testing strategy in a large European industrial manufacturing site.

Methods: The feasibility of a telemedicine-guided PCR-based self-collection approach was assessed for 150 employees (intervention group) and compared with a regular SARS-CoV-2 testing approach used for 143 employees (control group). Acceptance, ergonomics, and efficacy were evaluated using a software application. A simulation model was implemented to evaluate the effectiveness. An interactive R shiny app was created to enable customized simulations.

Results: The test results were successfully communicated to and interpreted without uncertainty by 76% (114/150) and 76.9% (110/143) of the participants in the intervention and control groups, respectively (P=.96). The ratings for acceptability, ergonomics, and efficacy among intervention group participants were noninferior when compared to those among control group participants (acceptability: 71.6% vs 37.6%; ergonomics: 88.1% vs 74.5%; efficacy: 86.4% vs 77.5%). The self-collection approach was found to be less time consuming (23 min vs 38 min; P<.001). The simulation model indicated that both testing approaches reduce the risk of infection, and the self-collection approach tends to be slightly less effective owing to its lower sensitivity.

Conclusions: The self-collection approach for SARS-CoV-2 diagnosis was found to be technically feasible and well rated in terms of acceptance, ergonomics, and efficacy. The simulation model facilitates the evaluation of test effectiveness; nonetheless, considering context specificity, appropriate adaptation by companies is required.

Keywords: COVID-19; SARS-CoV-2; self-sampling; simulation model; telemedicine; test strategy effectiveness.

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Conflict of interest statement

Conflicts of Interest: CDS reports grants, personal fees, and nonfinancial support from AbbVie, Apeiron, Gilead Sciences, Janssen-Cilag, GSK/ViiV Healthcare, and MSD; grants and personal fees from BBraun and Eli Lilly; grants from Cepheid; and personal fees from Formycon—outside the submitted work. S Weidlich reports personal fees and nonfinancial support from Gilead Sciences and Janssen-Cilag outside the submitted work. All other authors declare that they have no conflicts of interest.

Figures

Figure 1
Figure 1
Process flow. Upon registration and informed consent, participants were randomized into a self-collection (intervention) and regular testing (control) group. Swabs from participants of both groups were submitted to the study center and SARS-CoV-2 polymerase chain reaction (PCR) was performed. Questionnaire on the symptoms and risk factors was completed before conducting the procedure, whereas the questionnaire on user satisfaction was completed after the study procedure. The term ‘app’ refers to the software application principa (PlanOrg GmbH, Jena, Germany).
See this image and copyright information in PMC

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