Foundation Laid for At-Home COVID-19 Testing

All—or, at least, most—eyes are on COVID-19 vaccinations these days and things seem to be going well in the United States along those lines. But remember testing? In those dire months of surges before the vaccines came along, it was all about testing. COVID-19 testing will be around for a long time, predicts Luke Daum, PhD, the chief scientific officer for Longhorn Vaccines and Diagnostics, a company that makes sample transport devices and vaccine development. Daum tells Infection Control Today® that “we need to all be vaccinated. I’m a big proponent for the idea that everybody should get vaccinated as quickly as possible. But there is another way to get to the herd immunity stage, and that’s through natural infection. And that’s where testing comes in.”

Daum says that identifying people with COVID-19 so that they can be isolated will always be critical. And at-home testing will determine when they can return to work or school.

“They are two sides of the same coin,” says Daum. “And I just can’t get over how quickly the US and the globe in general has responded to this pandemic and how we’re approaching quickly the herd immunity.”

Infection Control Today®: OK. So at-home COVID-19 testing. That sounds like a simple solution. But there are questions about it, as you know. We don’t know if people will, first of all, administer the test correctly. And even if they do administer the test correctly, we don’t know whether they’ll follow the proper guidelines if they test positive. Those are two seemingly big hurdles for at-home testing.

Daum: Well, so I mean, as we approach the fall, we’re going to be getting into a time where schools are going to be reopening. And diagnostic testing sites are going to get inundated. So, the at-home collection strategy is a good one. But again, it relies on collection of a quality sample. So, instructions for use need to be included in these at-home kits that allow a user to simply open up the packaging, collect a quality sample with really easy to understand directions. And there are a couple of ways that groups are collecting samples. One of the most popular right

Luke Daum, PhD

now is a nasal sample, where the user un-opens a sterile flocked swab, takes this swab, inserts it up into the nose, not all the way back. We’re not talking about a nasal pharyngeal sample, which you probably had when you got tested at one of the CVSs and diagnostic testing sites that popped up. I’m talking about a nasal swab where it just goes into the nasal passage, you rotate the swab for 10 seconds, switch it to the other nostril, rotate the swab for 10 seconds and insert it into a collection to where the swab head is broken off. That’s the first way. The second way is the same kind of idea, except in the oral cavity. You don’t go back to the soft palate, like you would do for influenza testing. But you would instead take a sterile flocked swab, open it up for 10 seconds, roll it around in the oral cavity across the tongue, across the cheeks, and then break it off in a similar fashion into a collection tube and then seal that tube, send it through the mail. Send it back for analytical testing at a diagnostic center.

ICT®: People who have gotten the COVID-19 test say that it’s a pretty uncomfortable test.

Daum: Yes, for sure. Especially the nasal pharyngeal. I mean, you’ve seen pictures on YouTube or whatever of that type of test if you haven’t had one yet. But it’s a two- or three-inch thin flat swab that goes all the way back to the nasal passages all the way in the back. Those are not ideal for at-home testing. But what we’re finding is that these newer methodologies, which I just described to you—oral testing for 10 seconds, or nasal testing for 10 seconds in each nostril—is a good safe alternative that’s easy for people to do at home.

ICT®: If memory serves, I believe the Food and Drug Administration has approved at least one at-home test, maybe more. With their approval do they express any concerns about how these tests would actually work in the real world?

Daum: There are a lot of studies that are ongoing with regards to that. And the FDA has put out guidelines for how a sample should be collected and there are a number of groups who have included them into their EAU or emergency use authorization protocols for collecting for at-home use. And again, those are the types of methodologies that I described here on your podcast.

ICT®: Let’s speak in general about EUAs. As you know, there’s unfortunately vaccine hesitancy out there and, as we’ve reported here at Infection Control Today®, there’s even vaccine hesitancy among health care professionals. So, EUA. Do people hear that term and sort of recoil? And can you explain why they should not recoil at that?

Daum: No, I mean, you still have to go.... It’s an expedited federal approval. But it still goes through the same stringent checks and balances that a full 510(k) submission has to go through for acceptance as a fully cleared FDA product. So yes, it’s shrunken down, but desperate times call for desperate measures, as you know, and we needed to get these tests out as quickly as possible. We needed to get vaccines out as quickly as possible. And I think overall, with regards to testing in the US, no other country compares to us. We do a great job in all 50 states of testing, having turnaround testing for using qPCR collection for at-home, or through the drive through centers at CVS or Walgreens. Those services have been instrumental in diagnosing people quickly, keeping them isolated at home, and getting to the end of this. I don’t know about where you’re from, but in the state of Texas, we’re doing a real good job of testing. Testing is simple to do. Most of the sites are offering turnaround testing and same day or next day services now. And vaccination: Our vaccination schedule is going along really well in the state of Texas.

ICT®: Does it cause you concern that so much emphasis has been placed on vaccination? Should there be more emphasis placed on testing?

Daum: Well, testing and vaccination, in my opinion are two sides of the same coin. We need to all be vaccinated. I’m a big proponent for the idea that everybody should get vaccinated as quickly as possible. But there is another way to get to the herd immunity stage, and that’s through natural infection. And that’s where testing comes in. And it’s critical that we’re identifying people who are harboring COVID-19, getting them isolated in that home, using qPCR testing as a way for determining how long they should be at home, when they can go back to school or back to work. They are two sides of the same coin. And I just can’t get over how quickly the US and the globe in general has responded to this pandemic and how we’re approaching quickly the herd immunity.

ICT®: Tell me if this metaphor works. We’ve done some stories about how pharmaceutical companies do not really dive in when it comes to creating new antibiotics because it’s not cost-effective. They’d be spending a lot of money for something that will eradicate what they’re spending it on. Once they eradicate the disease or really contain it, there goes the demand. Do you see something like that? Is that a metaphor you can use for at-home testing or COVID-19 testing in general? Or will it be around for a long time?

Daum: I think for sure. And I think as we get into the fall…. One thing that I can say is through social distancing and wearing our masks, we’ve done a really good job with regards to that. And the case in point to that is influenza. I came out of a military background where we did strain surveillance for influenza viruses. I have never seen an influenza season not exist like the one we just went through. No cases in Texas, very few cases in the United States in general. All probably attributed to the fact that we’ve done a good job of social distancing and wearing masks. Having said that, as we approach the fall, the masks are starting to come off now. People are starting to get vaccinated and coming out of their homes. People are getting more comfortable. They’re getting cabin fever. They want to get out. Expect this fall in September, October, November, for influenza to re-emerge as a concern. And it’s going to be critical, as we move into that season, that we differentiate between COVID-19 cases and influenza cases. Testing is going to be critical. For the same types of PCR tests that we use for identifying COVID-19, we have similar tests for influenza. And many of them can be performed in a multiplex fashion at the exact same time. What I mean by that is one collected sample from a patient can be used and tested at the lab to test for multiple pathogens, including Influenza A, Influenza B, and COVID-19.

ICT®: You just talked about the possible reemergence of the flu next fall because theoretically people are not going to be a social distancing as much and not wearing a mask as much. Will that be helpful for health care providers to separate who has the flu from who has COVID?

Daum: That’s why it’s going to be important. And that’s why I advocate sample collection. And again, that’s what our company is about. I know we’re not speaking about that here. But sample collection is the first step in ensuring that a sample is preserved, that the RNA from these viruses and DNA from bacteria and other viruses are preserved and collected in these periods in such a way that they can be used to test for COVID-19. But then you can go back to the same sample and test for all the other respiratory pathogens.

ICT®: Wouldn’t it be easier for somebody at home to take an at-home test and get the reading themselves and then take the appropriate steps? What the question is asking is that the way you’ve defined, it seems like you have to put the sample in the mail. We all know what’s going on in the mail these days. And there might be some time between when the sample is taken and when the sample is diagnosed.

Daum: You just hit the nail right on the head. That’s the critical window. That’s the window in which you want to ensure that the sample is inactivated safely so that the people handling the package and getting it from point A to point B are not going to become infected by a leaky box. You also want to ensure that the stability of the RNA and the DNA in that collective tube from that swab is preserved in such a way that the integrity is there, regardless of temperature extremes, or delays in shipping, which happens all the time.

ICT®: Some kind of courier service would be involved, I guess?

Daum: Yes. A lot of groups now are collecting in medias that inactivate the sample in such a way that you don’t have to tick infectious disease boxes, and they have contracts established with UPS and FedEx, the regular couriers who transport those samples to a diagnostic site retesting.

ICT®: Do you envision a drop-off center? Somebody in a household has flu-like symptoms. They’re given the test. Somebody else in the household who’s well can drive to a nearby drugstore or a nearby hospital or a mailbox-like thing outside, and he can just dropped it in?

Daum: Those models are also out there. And they’re going to play a critical role this fall as well as the quick drive-through. What we call self-testing. Where maybe you don’t drive-through and someone you don’t know rams a nasal pharyngeal swab up your nose. But instead, someone opens a window, hands over a kit, you’re in your car. You self-administer the kit, put it in the tube yourself, close it up and hand it back to that person. And then they collect all the samples and tests throughout the day. That’s, another way.

ICT®: My audience comprises infection preventionists and also others, like environmental service teams. What will this do for them? I mean they work in hospitals for most part. Will this take some of the pressure off of them?

Daum: For sure. I mean, if we learned anything this last year, it was about being inundated with samples. It was a tough few months, when everybody wanted to get tested. And, you know, and again, this disease with asymptomatic cases, made it complicated and challenging for the regular hospitals to process the samples. The systems that you’re describing in this podcast, self-testing through drive-throughs, at-home testing, they’re going to be critical, not only as we approach the fall, but the next time something like this were to happen.

ICT®: Now the at-home tests. They can tell you whether or not you have COVID. If you don’t have COVID will they tell you what you have?

Daum: Some of them do and some of them don’t. I do see in the future groups that will be performing a menu, if you will, of testing, where you can tick a series of boxes to test for Influenza A, Influenza B, COVID-19, other respiratory pathogens.

ICT®: Doctor is there something I neglected to ask you that you think is pertinent to this conversation that you want to let people know about?

Daum: No. I think I think we’ve covered a lot here in terms of this topic. I think it’s going to be interesting to see how things move along in the fall. And it’ll be interesting to track the variants of COVID to see if any of those do end up emerging as the dominant circulating strains. There’s light at the end of the tunnel but we’re not quite there yet. And it’s going to require a lot of these types of strategies to ensure that testing is performed adequately. And we’re all doing what we need to do as citizens to beat this thing.

This interview has been edited for clarity and length.