Abstract
Background:
A commercial breakthrough of point-of-care testing (POCT) and self-tests for laypersons (direct-to-consumer applications, DTC) is anticipated based on the advancements in the development of lab-on-a-chip system (LOC) technology.
Objective:
The aim of this study was to investigate risks and benefits of LOC based diagnostic devices for healthcare and private self-testers.
Methods:
Interviews with 22 developers/researchers of LOC technology and 10 technology assessment experts were conducted about the (a) need for, (b) benefits, and (c) risks of LOCs for healthcare and as DTC applications. A qualitative content analysis was conducted.
Results:
Need for LOCs were seen mainly for healthcare, but not as DTC applications for fatal diseases. While benefits were seen mainly for healthcare and partially for DTC applications (e.g. faster diagnostics, more favourable diagnostics, POCT), risks were emphasised especially for DTC applications and less frequently for healthcare (e.g. various technical challenges, misinterpretation of test results, quality/reliability requirements).
Conclusions:
Medical expertise is the key imperative for the application of LOC based portable diagnostic devices in healthcare and particularly for self-testing. LOCs have to be designed to be easily operated and interpreted by self-testers. For healthcare, LOCs are envisaged to be a promising emerging technology with various benefits.