Abstract
Both home sample collection and home testing using rapid point-of-care diagnostic devices can offer benefits over attending a clinic/hospital to be tested by a healthcare professional. Usability is critical to ensure that in-home sampling or testing by untrained users does not compromise analytical performance. Usability studies can be laborious and rely on participants attending a research location or a researcher visiting homes; neither has been appropriate during COVID-19 outbreak control restrictions. We therefore developed a remote research usability methodology using videolink observation of home users. This avoids infection risks from home visits and ensures the participant follows the test protocol in their home environment. In this feasibility study, volunteers were provided with models of home blood testing and home blood sampling kits including a model lancet, sampling devices for dried blood spot collection, and model lateral flow device. After refining the study protocol through an initial pilot (n = 7), we compared instructions provided either as written instructions (n = 5), vs addition of video instructions (n = 5), vs written and video instructions plus videolink supervision by the researcher (n = 5). All users were observed via video call to define which test elements could be assessed remotely. All 22 participants in the study accessed the video call and configured their videolink allowing the researcher to clearly observe all testing tasks. The video call allowed the researcher to assess distinct errors during use including quantitative (volume of blood) and qualitative (inaccurate interpretation of results) errors many of which could compromise test accuracy. All participants completed the tasks and returned images of their completed tests (22/22) and most returned completed questionnaires (20/22). We suggest this remote observation via videolink methodology is a simple, rapid and powerful methodology to assess and optimise usability of point-of-care testing methods in the home setting.
Highlights
Point of care diagnostics and differences with home testing and sampling Point of care (POC) tests are most commonly operated by trained users in a healthcare environment, POC technology has made self-testing in the home feasible
Kits are available for home sampling for testing indicators of diabetes, cholesterol, urinary tract infections, and chlamydia, with results being determined by diagnostic laboratory analysis after mailing the sample (Shih et al, 2011)
Blood sampling kits In parallel to assessing the remote observation methodology, we explored if model components could be designed to simulate home sampling and home testing devices, using computer aided design (CAD) and rapid prototyping (3D printing). 3D printed model lancets were used to test if users could operate correctly, with a simple arrow indicating correct orientation allowing assessment of ease and consistency of following instructions (Figure 1)
Summary
Point of care diagnostics and differences with home testing and sampling Point of care (POC) tests are most commonly operated by trained users in a healthcare environment (for example screening tests for blood cholesterol or glucose), POC technology has made self-testing in the home feasible. Whilst pregnancy testing and blood glucose monitoring for diabetics remain the most common home self-test, home use devices are available for other conditions including infectious disease screening such as HIV (Peck et al, 2014; Wei et al, 2018). Home testing and sampling devices offer a range of benefits in medicine, including ability to inform treatment decisions, overcoming reluctance to undertake testing (e.g. in sexually transmitted disease diagnostics), removing the barrier of the patient having to attend a diagnostic testing centre, convenience, and the potential for expanding testing with reduced infrastructure requirements – the latter being important in low-resource settings (Garcia et al, 2015). The value of self testing is not straightforward, and there are disadvantages as well as advantages (den Oudendammer & Broerse, 2019)
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