AfriDx Policy Briefs

Policy Brief: the potential role of isothermal nucleic acid tests in addressing COVID-19 diagnostics challenges in Ghana

Nucleic Acid Testing (NAT) via reverse-transcription quantitative polymerase chain reaction (RT-qPCR, also known as PCR testing) is the gold standard for early-stage detection of COVID-19. However, antigen rapid diagnostic tests have taken over in many LMICs due to their affordability, speed and ability to be used in the home or at the point of care without laboratory infrastructure.

AfriDx explored the potential for a NAT called RT-LAMP which is closer in sensitivity to RT-qPCR but can be used in a resource limited laboratory or health centre in Ghana.

Through collaboration with AfriDx partners and a survey of the diagnostics community, we identified that RT-LAMP tests have potential to provide more affordable, easier to use and accessible NATs. However, adoption is currently non-existent in Ghana. We explore why and make three policy recommendations which could ensure that the potential benefits of access to RT-LAMP tests are realised.

Policy Brief: regulating local manufacturing of IVDs in Ghana

AfriDx is a UK-Denmark-Ghana initiative to develop systems for the clinical diagnosis of Covid-19 designed to be manufactured in low and middle-income countries. We considered it essential to better understand the regulatory landscape in Ghana and any recommendation that could be made which would ease the path of local manufacturers to bring products to market.

In this policy brief we describe the process for gaining regulatory approval of locally manufactured IVDs in Ghana. Ghana is generally considered to have a mature regulatory capacity and unlike many countries in Sub-Saharan Africa, it has a route for regulating locally manufactured IVDs. However through collaboration with AfriDx partners and a survey of the diagnostics community we identified remaining challenges.