Current diagnostic capacity to detect SARS-CoV-2 is centralised, requires complex workflow with highly trained staff and the diagnostic tests themselves can be relatively inaccessible, slow to produce results and high in cost. Thus, this consortium seeks to fill an urgent unmet medical need for a mobile and rapid diagnostic test system for COVID-19 based on lateral flow assays. The project aims to provide a highly sensitive means for diagnosing SARS-CoV-2 infection at point-of-need.
There are significant limitations to the current paradigm to wait until COVID-19 symptoms appear before people are tested in centralised facilities. SARS-CoV-2 can be transmitted by patients before symptoms appear or by asymptomatic individuals. Since the incubation period lasts several days, this paradigm leads to the creation of a blind spot: many people that are transmitting the disease are currently not diagnosable. Also, state-of-the-art rapid tests cannot reliably diagnose patients in the early stages of the disease when they are already infectious due to the limited accuracy. The only way to remedy this blind spot, in the current absence of a vaccine against SARS-CoV-2, is to develop a new type of diagnostic test that is mobile, fast, cheap, lab-independent and accurate to stop the chain of infection.
The consortium will develop a rapid diagnostic test system, based on lateral flow assays (e.g. these types of assays are commonly used for home pregnancy tests). Novel methods include an electrochemical read-out system and sample processing steps that will optimise the sensitivity and precision of the test, while also delivering point-of-need (i.e. rapid turn-around time and immediate availability of the test result). The technology will be validated with samples collected from COVID-19 patients and against the gold standard, routinely performed lab-based PCR tests. The project will also situate itself in an up-scalable manufacturing process, for possible future rapid and broad deployment.
This new proposed lateral flow assay will be a unique tool with high potential to improve surveillance of infectious diseases such as COVID-19, and to decrease mortality and the high economic burden of the pandemic.
Banner illustration above: The consortium works to create a rapid, point-of-need diagnostic test. A sample droplet is loaded onto the sample pad (lower left corner) of the assay. The viral proteins in the sample are then immobilised and labelled. The readout device then accurately quantifies the labelled proteins and displays the result on the screen.
