DECISION researchers are working on a while-you-wait throwaway testing kit that works by amplifying the virus’ genetic material
The partners in the DECISION project are developing an easy-to-use, low-cost, disposable test for COVID-19 that can give results within minutes. The idea is that it can be deployed anywhere; at drive-through testing centres, airports, physician offices, hospitals, quarantine centres, and eventually, even in people’s own homes. According to Dr Anastasia Liapis, Vice-president of strategic marketing and partnerships at GNA Biosolutions GmbH, a German SME and DECISION project lead, “Few novel amplification technologies exist that can deliver miniaturised, low-cost systems for molecular diagnostics, and the infectious disease outbreaks we are seeing globally are proof of just how necessary new approaches are to fight against these unpredictable threats.”
“Our perspective was that simple, portable, fast molecular test is a critical tool missing from the current landscape, and we have the core technology to enable that.”
The testing platform is powered by a technology called Pulse Controlled Amplification (PCA®), a ‘next-generation nucleic acid amplification technology’ that enables ‘sample-to-answer workflows in 15 minutes or less’. GNA Biosolutions received funding as part of a previous IMI project, FILODIAG, an Ebola rapid diagnostics project. This support contributed to the development of PCA®.
Gold-standard lab test, only faster and smaller
“In a PCR test (polymerase chain reaction), the genetic makeup of the virus is detected in the laboratory to assess viral infection. However, typically PCR test results are available after several hours. Furthermore, it often takes much longer for the patient to get their result depending on the infrastructure around it. This is because it takes time for a sample to make its way to the laboratory where the evaluation is made. Once that evaluation is available then the result needs to go back to the test site and finally to the patient.”
Since the coronavirus outbreak was first declared in early 2020, there has been a regular stream of reports of companies proposing rapid tests for the virus. The most reliable and safest method of testing for active COVID-19 infection is PCR, according to Dr Liapis. “Our proposed test works like PCR at the chemical level, with the needed sensitivity, but is much faster (minutes rather than hours) at much lower cost. It’s still a molecular amplification of the viral genetic material, but we can miniaturise and simplify and accelerate the process so the test can be done on-site, by anyone.”
PCR-based ‘rapid tests’ exist, but are very expensive, and not suitable for broad implementation, according to Dr Liapis. “Furthermore, the meaning of rapid with these tests is blurry - the fastest takes 15 minutes but some take several hours. There are also antigen-based rapid tests, which means they directly detect components of the virus itself. While less expensive than the PCR, and faster, they have not been very accurate, which means they have the potential to produce a large number of false negative results. This is because typically they are much less sensitive (1,000 to 10,000 times less sensitive) than the PCR based tests.”
The while-you-wait aspect is a key advantage, she says. “We are targeting 10-20 minutes. The use cases will vary depending on the country specific regulations and the infection situation on the ground, but airport, school, local clinic, pharmacy, nursing home, eventually at home… all these are potential cases.”
Timeline
As for when it will be ready to be deployed, Dr Liapis says “First demonstrators of the disposable molecular platform and coronavirus test will be available in 2021 and could be provided to emergency first responders and public health authorities. The priority will be validation with healthcare professionals,”
“…however home testing is a possibility with such a system.”
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