20-minute COVID test

Recently Boris Johnson announced an ambitious plan, which he dubbed his “moonshot”, to test our way out of the Covid crisis and back to normality. But the price tag of this proposed multimillion scale daily testing regime is nearly as much in itself as the cost of running the entire National Health Service. Unsurprisingly, many are sceptical, not least because some of the technology needed to deliver it does not exist yet. So you’d think that a new coronavirus test developed by Anglia Ruskin researcher Stephen Bustin, that delivers a result in just 20 minutes, would have health secretary Matt Hancock rubbing his hands together and offering to help. But, as he explained to Chris Smith, that’s not been his experience...

Stephen - We have developed a test that is much faster than anything that is available at the moment. Instead of taking an hour and a half, our test takes 15 minutes.

Chris - Goodness me. Now tell me how it works.

Stephen - You would spit into a test tube, and we would spend about five minutes extracting the genetic information from the virus. That genetic material is a chemical called RNA, which we cannot use in our test. We therefore have to convert it into a second chemical, which is DNA. That DNA is then put into our test, which is a PCR based test. And it copies the DNA copy that we have made several million fold, which we then can detect using sensitive instrumentation.

Chris - This is very similar though, to what is going on in diagnostic laboratories all over the world, except they're taking hours to do it. Why are you able to do it in 20 minutes? How have you done that?

Stephen - Well, firstly, our test detects more than one viral gene. We look at three viral genes. Secondly, we have used a better method, a faster method. Most labs use methods that are 30 years old. They take a long time to convert the viral RNA into DNA, and they take a long time to do the test itself. We have streamlined this to do this in 30 seconds. And then one second, and one second, bursts.

Chris - Interestingly, you said you're using saliva. This is not routinely being done though, is it? Most people are familiar with having what feels like a brain biopsy, with an enormous, great long thing being rammed up your nose and swapped into the back of your throat. So why saliva?

Stephen - Well, saliva is obviously a lot more easy to get hold of. You spit into a tube and this then allows you to extract your nucleic acid from that saliva sample. Saliva is as good a sample as a swab, and in some instances, in some papers suggest that it is even better.

Chris - So if one does a head to head between what we're currently doing in diagnostic laboratories across the country, and your new method, does it perform at least as well, or possibly even better than what we're doing at the moment?

Stephen - The test itself is better than what people are using at the moment. Out test can detect a single copy of the viral genome, and we tested our tests on samples from Broomfield Hospital. And we found that in every single case where the hospital had a positive, we had a positive, and in every single case where they had a negative, we had a negative.

Chris - Could you use the existing machines and platforms which are running across the country, and in fact, across the world, to introduce this test, or does this need a whole new load of equipment, and a whole load more expensive training before it could be launched?

Stephen - No, this test will work with any instrument that can run real-time PCR.

Chris - Have you spoken to the people who are in charge of testing in the UK?

Stephen - Yes. We've done two things. We applied for funding from Innovate UK, and we had four referees, and they all gave it very high ratings, but it wasn't funded. I then went to my local MP, and talked to him who put me in touch with the health secretary. The problem is that unless the test is CE marked or FDA approved, it is very difficult to get it accepted rapidly. And as a university, we don't have the facilities to do a proper CE marking for example. So it is not easy to introduce a new test like this.

Chris - What you're saying is then, that bureaucracy is effectively getting in the way of a test being introduced that could in fact be an order of magnitude faster than what we can do at the moment?

Stephen - It's one problem. Yes.

Chris - What did Matt Hancock say?

Stephen - He put me through to Lord Bethell, who then put me through to somebody else, and it wasn't a totally satisfactory interaction.

Chris - Oh, and what grounds were they giving then? Were they just saying: You have to go through the right channels and just go away. I mean, that's not very constructive, is it?

Stephen - There's no easy and fast Dragon's Den type approach to pitching something, and then getting funding for it.

Chris - How much do you think you need Stephen, to actually get a CE Mark? This is, and for people not in the know, this is like a badge of honour that says this meets, or passes muster, isn't it? A CE Mark says, this is a tried and tested, validated, quality assured test. That's what you need, isn't it? How much is that going to cost, do you think then to get that?

Stephen - It's not just the question of cost, it's a question of, we're not set up to do that. So what I would like to happen is, for a manufacturer to get in touch with us, or for us to be able to get in touch with a manufacturer, and get them to do it with us. And that's what we're trying to do at the moment.

Chris - Okay. Well, we will throw down the gauntlet to people listening to this. And if anyone would like to get in touch, who do they get in touch with, to say to you, we'll take your pain away and we'll get this test out there.

Stephen - I can give you my email, Stephen.bustin@Aru.ac.uk.