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SARS… or something else?

RAPID-COVID’s platform can detect up to 30 different infections in one test. This will help stem the spread of COVID-19 by getting the diagnosis right - especially important in flu season

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Since the beginning of the coronavirus outbreak, there have been reports of somewhat peculiar symptoms of COVID-19 infection – like loss of taste or smell, frostbite-like appearance of toes, and a fever that seems to go away before coming back with a vengeance. More commonly reported symptoms however, are also common to countless other illnesses. Being able to differentiate between COVID-19 and infections like rhinoviruses or influenza is important because it will help stop the spread by isolating the right people. It will also prevent heath workers from doling out the wrong diagnoses and, thus, drugs.  

A recent study showed that approximately 6% of people infected with SARS-CoV-2 and 18% of people without SARS-CoV-2 were infected with other pathogens. GeneFirst, the coordinators of the newly launched project RAPID-COVID, have developed a prototype using its innovative proprietary technology called MPA (Multiplex Probe Amplification) to simultaneously detect and differentiate SARS-CoV-2 as well as 30 other common respiratory bacteria and viruses. The consortium want to analytically and clinically validate (CE-mark) the assay on two automated platforms for Point-of-Care (PoC) and central laboratory high-throughput testing. They aim to commercialise the assay for €9.00 per test.

We asked Winnie Wu, Chief Operations Officer of GeneFirst Limited, some questions about the project. 

What’s the best possible outcome scenario for the RAPID-COVID project? And how quickly can we reasonably hope to have a working multiplex detection system ready for sale/use?

The best possible scenario for the RAPID-COVID project is that we can demonstrate the health benefits of a complementary respiratory screening strategy involving both Point of Care (PoC) testing and high-throughput automation to manage patients more effectively. This will be especially important during the flu seasons where a resurgence of SARS-CoV-2 is predicted in the population, as are other common respiratory pathogens such as Influenza A, respiratory syncytial virus (RSV) and rhinovirus.

It would be prudent to have tests that not only give results for COVID-19 but also other pathogens, viral or bacterial, so that patients can receive the most appropriate treatment straight away. The RAPID-COVID assay will allow healthcare professionals to determine this. We already have proof of principle assay designs that we wish to use for the project, and we can reasonably expect to have working prototypes, automated on the platforms and ready to be used for clinical validation, within 4 to 6 months of project start. Ultimately, we hope that by the end of the project we will be able to implement these systems straight away.

Can you guide us through a hypothetical scenario in which a COVID-19 case is detected and referred for further testing using your technology?

The implementation strategy will depend on the healthcare system (centralised or decentralised routes of testing, or potentially a combination of the two). The end-users are either nurses or doctors who will be taking the sample, or laboratory professionals running the high-throughput platforms. 

In a hypothetical scenario using the PoC device as a frontline test that differentiates the most common pathogens, including Flu, RSV and rhinovirus, the patient is admitted to the hospital for suspected COVID-19 infection. The healthcare professional takes a throat or nasal swab, and runs the sample on the platform. After 45 minutes, the result is generated. If the patient is COVID-19 positive, he or she is admitted to the designated department for COVID-19 cases, and receives the appropriate treatment.

In another hypothetical scenario, a large number of patients are admitted for suspected COVID-19 infection. Their nasal or throat swabs are sent to a central laboratory where the testing is carried out on the high-throughput system. These results are ready after 3.5 hours, and the patients are triaged according to the infections they’re found to have.

In a third scenario, during flu season, the screening could take place before or during a visit to the GP, whether by a healthcare professional or by the patient at home using a home testing swab. The swabs are sent to the lab to be tested on the high-throughput system, and patients are triaged accordingly.

It is also possible that both approaches are adopted; patients firstly receive an initial diagnosis using the PoC platform for screening, followed by the high-throughput multiplex system for further confirmation testing.  Our tests are highly adaptable to support different testing strategies in the upcoming flu season during this COVID-19 pandemic. 

How innovative is this? Does it already exist in a same/similar form? What’s different about your innovation, if so?

There are a number of key aspects that, when combined, demonstrate the innovation in our project. Firstly, our technology, Multiplex Probe Amplification, offers detection and differentiation of different targets in a one-tube design. This is a unique feature of the technology; it’s true multiplexing, as opposed to a complicated design involving numerous tubes. A survey of the market suggests that the availability of reliable, multiplexed testing is still limited, and the majority of these testing platforms do not currently detect SARS-CoV-2.

 

It’s also automated and compact; many single-gene or multiple-gene detection kits are manual, meaning that the assay setup can still be time-consuming if the operator is processing a large number of patient samples at a time.  Meanwhile, there are multinational diagnostic firms that offer automated platforms, although these often have large footprint, and unless the platform is already available, it makes implementation challenging.  We will offer a high-throughput robotic instrument with a small footprint (ASCIA, PrimaDiag) that can be fitted on a laboratory benchtop without compromising time-to-result or throughput.

 

Our partner for software development, BioSystemika, will create a user-friendly interface coupled with a powerful algorithm for calling the correct target, or pathogen. This allows for a complete end-to-end automated workflow that can be integrated into any clinical laboratory. Clinical effectiveness study is also part of this project; this is often not included in an in-vitro diagnostic design but is hugely important in understanding the impact to patient outcomes and healthcare practices. 

What do you imagine is going to be your biggest difficulty in carrying out the research?

The biggest challenge is most likely to be the unpredictability with the flu season as it may have an impact on assay design and how quickly we need to implement the prototypes.

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