Portable, low-cost hardware for decentralized COVID-19 diagnostics
Limited access to diagnostics represented a significant challenge in maintaining public health during the COVID-19 pandemic. While this was the result of multiple factors, a key contributor to the problem was that public health systems were completely dependent on a single centralized diagnostic method known as the reverse transcriptase polymerase chain reaction (RT-PCR) and the related instrumentation, both of which suffered from supply chain issues, especially at the beginning of the pandemic.
To tackle this issue, a team of researchers from Canada, Colombia and Ecuador, supported by IDRC, worked on technology development and the validation of low-burden diagnostic systems for decentralized public health. The goal was to develop and validate molecular and hardware tools to provide alternate and distributed methods of diagnosing the SARS-CoV-2 virus and surveillance of the SARS-CoV-2 antibody development.
The team developed PCR-free diagnostics for the SARS-CoV-2 virus and an assay to track patient immunity to the virus, which is important in tracking patient response to vaccination and population susceptibility. In parallel, they developed a low-cost instrument called PLUM (CAD2000 vs the conventional CAD30,000 instruments), that served as a lab-in-a-box to run these assays outside a laboratory.
Key deliverables for this project
- Development and optimization of reverse transcription loop-mediated isothermal amplification (RT-LAMP) assays for the SARS-CoV-2 virus. This is an isothermal diagnostic method with sensitivity comparable to the gold standard RT-PCR but with the advantages of low-cost and low-burden requirements for instrumentation.
- Development of two RT-LAMP output signals (fluorescent, colorimetric).
- Technology transfer of the RT-LAMP assay to project members in Canada, Ecuador and Colombia.
- Development of two PLUM readers that are capable of incubating reactions for LAMP assays (65°C), one with colorimetric monitoring and another that can monitor fluorescent outputs.
- Patient trials in Canada, Ecuador and Colombia of the RT-LAMP assays in parallel with the gold standard RT-PCR assay as a comparator.
- Technology transfer of the serological assay for SARS-CoV-2 antibodies to teams in Canada, Ecuador and Colombia. Adaptation and optimization of the serological assay for use with reagents that are available at international sites.
- Lab-based validation of the serological assay with the PLUM reader.
- Patient trials in Canada, Ecuador and Colombia of the serological assays in parallel with the gold standard plate reader-based approach.