Emerging technologies in point-of-care molecular diagnostics for resource-limited settings

Abstract

Emerging molecular technologies to diagnose infectious diseases at the point at which care is delivered have the potential to save many lives in developing countries where access to laboratories is poor. Molecular tests are needed to improve the specificity of syndromic management, monitor progress towards disease elimination and screen for asymptomatic infections with the goal of interrupting disease transmission and preventing long-term sequelae. In simplifying laboratory-based molecular assays for use at point-of-care, there are inevitable compromises between cost, ease of use and test performance. Despite significant technological advances, many challenges remain for the development of molecular diagnostics for resource-limited settings. There needs to be more advocacy for these technologies to be applied to infectious diseases, increased efforts to lower the barriers to market entry through streamlined and harmonized regulatory approaches, faster policy development for adoption of new technologies and novel financing mechanisms to enable countries to scale up implementation.

Keywords::

• in vitro diagnostics
• infectious diseases
• molecular diagnosis
• point-of-care
• resource-limited settings

Financial & competing interests disclosure

RW Peeling is funded by the Bill & Melinda Gates Foundation, WHO, UNITAID and Grand Challenges Canada. R McNerney is funded by WHO, Grand Challenges Canada and the UK Technology Strategy Board. The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.

No writing assistance was utilized in the production of this manuscript.

Key issues

• Many molecular technology platforms have been developed that could be used to improve the diagnosis of major infectious diseases and for monitoring progress toward disease elimination.

• More advocacy is needed to ensure that molecular technologies are applied to the detection of infectious diseases and antimicrobial resistance in resource-limited settings.

• Despite significant technological advances in the development of molecular diagnostics for resource-limited settings, many challenges remain in its delivery.

• Global and regional efforts are needed to lower barriers to market entry through streamlined clinical evaluations and harmonized regulatory approaches.

• Countries need to develop technology assessment programs to facilitate faster policy development for adoption of novel point-of-care molecular technologies.

• Novel financing mechanisms are needed for countries to scale up implementation and increase access to point-of-care molecular tests in resource-limited settings.