Abstract

Point of care (PoC) diagnostics are at the focus of government initiatives, NGOs and fundamental research alike. In high-income countries, the hope is to streamline the diagnostic procedure, minimize costs and make healthcare processes more efficient and faster, which, in some cases, can be more a matter of convenience than necessity. However, in resource-limited settings such as low-income countries, PoC-diagnostics might be the only viable route, when the next laboratory is hours away. Therefore, it is especially important to focus research into novel diagnostics for these countries in order to alleviate suffering due to infectious disease. In this review, the current research describing the use of PoC diagnostics in resource-limited settings and the potential bottlenecks along the value chain that prevent their widespread application is summarized. To this end, we will look at literature that investigates different parts of the value chain, such as fundamental research and market economics, as well as actual use at healthcare providers. We aim to create an integrated picture of potential PoC barriers, from the first start of research at universities to patient treatment in the field. Results from the literature will be discussed with the aim to bring all important steps and aspects together in order to illustrate how effectively PoC is being used in low-income countries. In addition, we discuss what is needed to improve the situation further, in order to use this technology to its fullest advantage and avoid “leaks in the pipeline”, when a promising device fails to take the next step of the valorization pathway and is abandoned.

Highlights

  • Low- and middle-income countries (LIC/MICs) face severe challenges due to limited economic opportunities

  • It may be possible to determine at which discrete steps the transition fails and a Point of care (PoC) device that was maybe once-promising prototype, or10, intellectual property (IP) considerations preventing market access

  • Resource-rich settings do not focus on research on neglected tropical diseases (NTDs), which is already evident from their name

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Summary

Introduction

Low- and middle-income countries (LIC/MICs) face severe challenges due to limited economic opportunities. Given the economical and infrastructural challenges in LIC, PoC diagnostics, which are often characterized by being independent of laboratory or medical infrastructure, as well as being highly affordable and holding considerable promise to improve the situation. Due valorization into real products, several review articles on the topic have been written in past years. Most most are are specialized specialized on on one one specific specific aspect—for aspect—for example example some some authors authors looked looked in in depth depth at at valorization into real products, several review articles on the topic have been written in past logistical shortcomings [2]; others investigated funding and collaboration considerations [3].

Migliozzi
Introduction”
Funding Availability and Focus
Choosing a Suitable Design Philosophy
Taking Aim
Funding in LICs
Incentives to Change Focus in HICs
Device Characteristics
Being ASSURED
How Necessary Is It to Be ASSURED?
Steps towards an Effectively Usable PoC Device
Funding and IP
Regulations
Integrated Market Expertise
Device Quality
Economic and Social Placement
Product Distribution
The Usage
Healthcare Management
Patient Management
Training
Use by Trained Doctors
View on PoC
Main Findings
Findings
Outlook

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