Policy Considerations for Mobile Biosensors

Abstract

Meeting policy requirements is essential for advancing molecular diagnostic devices from the laboratory to real-world applications and commercialization. Considering policy as a starting point in the design of new technology is a winning strategy. Rapid developments have put mobile biosensors at the frontier of molecular diagnostics, at times outpacing policymakers, and therefore offering new opportunities for breakthroughs in global health. In this Perspective we survey influential global health policies and recent developments in mobile biosensing in order to gain a new perspective for the future of the field. We summarize the main requirements for mobile diagnostics outlined by policy makers such as the World Health Organization (WHO), the World Bank, the European Union (EU), and the Food and Drug Administration (FDA). We then classify current mobile diagnostic technologies according to the manner in which the biosensor interfaces with a smartphone. We observe a trend in reducing hardware components and substituting instruments and laborious data processing steps for user-friendly apps. From this perspective we see software application developers as key collaborators for bridging the gap between policy and practice.

Enzyme-Assisted Nucleic Acid Detection for Infectious Disease Diagnostics: Moving toward the Point-of-Care

“…For example, the policy and regulation governing mHealth concepts, software, and devices provide a headache for regulatory bodies that have evolved to work within the traditional centralized medicine model, though there are advanced global efforts to make vital reforms here. 160 There must be caution with regard to how mHealth solutions are marketed and implemented, taking great care not to impose upon people’s privacy, and balancing this against potential stifling of innovation and impact. Another consideration is that the deployment and operation of diagnostics should not become completely reliant on digital connectivity, given that 33% of the global population are not connected to mobile Internet.…”

Nano-engineered tools in the diagnosis, therapeutics, prevention, and mitigation of SARS-CoV-2

“…Its detection limit in whole blood was 5 pg mL −1 . These sensors are now modelled to link to smartphones to increase their feasibility and robustness [ 43 ].…”

The Role of Aryldiazonium Chemistry in Designing Electrochemical Aptasensors for the Detection of Food Contaminants

“…Moreover, the extensive use of antibiotics in animal feed in order to increase production is associated with the spread of resistant bacterial strains for which current treatments are ineffective [ 1 ]. Despite their high sensitivity, many of the traditional assays employed for detection of food contaminants, such as HPLC and mass spectrometry, are expensive, laborious, and demand highly trained staff, and therefore have limited suitability for areas with poorly equipped facilities and shortages of specialists [ 7 , 8 , 9 , 10 , 11 , 12 ]. In this context, the efforts to develop accurate, easy-to-use, disposable, and inexpensive devices for food safety control have greatly expanded.…”