Assessing the Potential Deployment of Biosensors for Point-of-Care Diagnostics in Developing Countries: Technological, Economic and Regulatory Aspects

Abstract

Infectious diseases and antimicrobial resistance are major burdens in developing countries, where very specific conditions impede the deployment of established medical infrastructures. Since biosensing devices are nowadays very common in developed countries, particularly in the field of diagnostics, they are at a stage of maturity at which other potential outcomes can be explored, especially on their possibilities for multiplexing and automation to reduce the time-to-results. However, the translation is far from being trivial. In order to understand the factors and barriers that can facilitate or hinder the application of biosensors in resource-limited settings, we analyze the context from several angles. First, the technology of the devices themselves has to be rethought to take into account the specific needs and the available means of these countries. For this, we describe the partition of a biosensor into its functional shells, which define the information flow from the analyte to the end-user, and by following this partition we assess the strengths and weaknesses of biosensing devices in view of their specific technological development and challenging deployment in low-resource environments. Then, we discuss the problem of cost reduction by pointing out transversal factors, such as throughput and cost of mistreatment, that need to be re-considered when analyzing the cost-effectiveness of biosensing devices. Beyond the technical landscape, the compliance with regulations is also a major aspect that is described with its link to the validation of the devices and to the acceptance from the local medical personnel. Finally, to learn from a successful case, we analyze a breakthrough inexpensive biosensor that is showing high potential with respect to many of the described aspects. We conclude by mentioning both some transversal benefits of deploying biosensors in developing countries, and the key factors that can drive such applications.