Policy Brief: the potential role of isothermal NATs in addressing COVID-19 diagnostic challenges in Ghana
Executive Summary
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 which is closer in sensitivity to RT-qPCR but can be used in a resource limited laboratory or health centre in Ghana. This was based on reverse-transcription loop-mediated amplification (RT-LAMP) which requires comparatively simple equipment and can be freeze-dried for long-term storage.
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 within both clinical and non-clinical settings. However, adoption is currently non-existent in Ghana for any disease target. This is partly due to the early stage of development of many tests, with limited options on the market worldwide and none with regulatory approval in Ghana. In particular, the lack of isothermal NATs with WHO approval through their Emergency Use Licence or prequalification (PQ) programmes is a major barrier. There are also concerns about higher false positive rates and lower sensitivity in RT-LAMP compared to RT-qPCR. Moreover, successful integration of new workflows and data collection modes within the health system was a concern raised by surveyed clinicians. This illustrates that a systems approach is needed to diagnostics innovation which includes optimising the technology alongside operational research, stakeholder engagement and support at all levels of the health system.
The following three policy recommendations could ensure that the potential benefits of access to RT-LAMP tests for SARS-CoV-2 and other diseases are better understood and realised:
- A national pathway for translating research on NATs out of academic research labs through to clinical trials phase, alongside guidance for preparation for regulation by the Ghana FDA would be beneficial.
- Integration of isothermal NATs with existing testing and reporting within the health system is essential. This is particularly critical where use of point of care or near point of care NATS introduces a new tier of data collection at clinics and non-clinical sites. Any roadmap for adoption needs to consider digital infrastructures alongside the NAT technology itself.
- The Ghana Ministry of Health should play a key role in informing diagnostic innovators and manufacturers of national diagnostics demand, which will be critical to ensure there is a business case to adopt new innovations.
Full Brief
Executive Summary
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 which is closer in sensitivity to RT-qPCR but can be used in a resource limited laboratory or health centre in Ghana. This was based on reverse-transcription loop-mediated amplification (RT-LAMP) which requires comparatively simple equipment and can be freeze-dried for long-term storage.
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 within both clinical and non-clinical settings. However, adoption is currently non-existent in Ghana for any disease target. This is partly due to the early stage of development of many tests, with limited options on the market worldwide and none with regulatory approval in Ghana. In particular, the lack of isothermal NATs with WHO approval through their Emergency Use Licence or prequalification (PQ) programmes is a major barrier. There are also concerns about higher false positive rates and lower sensitivity in RT-LAMP compared to RT-qPCR. Moreover, successful integration of new workflows and data collection modes within the health system was a concern raised by surveyed clinicians. This illustrates that a systems approach is needed to diagnostics innovation which includes optimising the technology alongside operational research, stakeholder engagement and support at all levels of the health system.
The following three policy recommendations could ensure that the potential benefits of access to RT-LAMP tests for SARS-CoV-2 and other diseases are better understood and realised:
- A national pathway for translating research on NATs out of academic research labs through to clinical trials phase, alongside guidance for preparation for regulation by the Ghana FDA would be beneficial.
- Integration of isothermal NATs with existing testing and reporting within the health system is essential. This is particularly critical where use of point of care or near point of care NATS introduces a new tier of data collection at clinics and non-clinical sites. Any roadmap for adoption needs to consider digital infrastructures alongside the NAT technology itself.
- The Ghana Ministry of Health should play a key role in informing diagnostic innovators and manufacturers of national diagnostics demand, which will be critical to ensure there is a business case to adopt new innovations.