Video and Transcript of Path Forward Ask Me Anything – COVID-19 Testing
Hello, everyone. My name is Mara Aspinall. I'm a professor of practice in biomedical diagnostics at Arizona State University and managing director of Health Catalysts Group. I'm here to talk about asking me anything around COVID testing. I want to thank the U.S. Chamber of Commerce Foundation for sponsoring these events and being here to be able to answer your questions. I'm looking forward to our session. Thank you for those who put in questions early, and we'll continue hopefully a very active conversation for the next 30 minutes.
I believe we will have our first question, and there were a number that were similar to this.
Question: If a person is fully vaccinated, in what circumstances, if any, would COVID-19 testing be advised?
Let me start here with what is probably likely to be the way we're going to go forward is a nuanced answer. Let me first say, if you're an individual, the CDC has made clear that even if you're exposed and you believe you're exposed to COVID-19, you do not need to quarantine, and you do not need to test, of course, unless you're symptomatic. If you begin to feel symptoms of any type, and there are a broad range of symptoms for COVID-19, then indeed you should test. What is key here to understand, the first two vaccines, the mRNA vaccine, the Pfizer and Moderna have between a 90% and 92% effectiveness in real-world situations. In the clinical trials, they were 94% and 95%, but in real world, 90% to 92% is extraordinarily successful.
However, it is not 100%. So, can you still get COVID-19? The answer is yes. The likelihood of you having a severe case is virtually zero, because both vaccines were essentially a hundred percent in preventing aggressive disease hospitalization, or death. But, in answer to the question, is there any point that you might still test somebody who has been fully vaccinated and waited the 14 days post their second vaccination, or one for J and J? My answer is yes. If it is part of a broad screening program in a school or in an office environment, where the critical issue is reducing potential exposure, and giving everyone in that environment full confidence to go back to work or back to school, personally, I would recommend putting fully vaccinated people into that testing regimen. I think it is for abundance of caution, and the cost of testing has gone down so much. I believe that that would be most effective.
Question: How do we determine which rapid tests are most accurate? There seems to be pop-up testing sites all over.
Jim, that's a great question. First, let me clarify that most rapid tests are what's called antigen tests. There are a few rapid tests, including, and I can show people what they look like with some samples, but the two additional rapid tests that are sometimes in these sites are Lucira and Visby. This is what's called the LAMP technology, and this is a PCR technology. But most of the tests that are done on rapid are tests like, and I'm going to open the Abbott test, which is a card system or a pregnancy test-like system. This is the Abbott one. If you haven't seen it, it looks like this. And you use this strip. It's a bit of a process. You use it to get a nasal swab, and you put it in here with some chemicals, swirl it around, and get an answer.
Most of the other tests, however, look more like this, which is a system for which you get a nasal swab, either attached or separate, put it in a small cartridge. And you see one line for negative, that's the test, the control, and two lines for positive. So, the answer is I would go as a lay person to the FDA website, or a website that I maintain with easier to read information, I think, which is called testingcommons.com through Arizona State University. And we list the sensitivity and specificity of a test. For those who aren't familiar, what you want is a hundred and a hundred. Higher numbers are best. And if something is 98% sensitive, it means it has 2% false negative. If something is 97% specific, it means that it has 3% false positive. For most of the antigen tests, they're pretty close to a hundred percent specific, i.e. very, very few, if any, false positives. Their challenge is that they could be between 95% and 98% sensitive, meaning they have 5% to 2% false negatives.
What the FDA has just done in the last week is announced that with these antigen tests, these pregnancy-like tests like this, what they have done is said, "You know what, if you use these tests twice a week, 24 hours apart, 36 or 48 hours apart, they are equivalent to the PCR tests." Now, why is that? It's because these antigen tests are the tests really for contagiousness. And they have the ability, usually one day, of missing the early, early infections when somebody is not contagious, but the virus is starting to increase. And the way viral load works is it increases very fast, and decreases very slowly. So you run the risk, you got small risk about 14 hours where you might be negative on an antigen test and positive in a PCR test. And that's why the FDA is now saying, "Let's do these tests, use them, but use them in a way that you do two antigen tests on what's called serial testing.
So, long answer to say I would be confident with all of the tests that the FDA has authorized in EUAs, but there are slight differences in how they're used. Certainly, some differences in how they cost and what's available, but all of them are at least 95% sensitive and specific. And I believe, today, virtually all but one are 96% or 97% specific and sensitive.
Next question. This is interesting and very much related.
Question: Why does Hawaii require Nucleic Acid Amplification Test from a CLIA lab? Is this a better test?
It's directly related to my last question. First of all, nucleic acid test is a PCR test. Many of you have heard the state "PCR" and said those are the gold standard. Back to what I just said, the PCR tests are virtually all the time done in a central lab. You take a sample, whether it's, I go like this, a nasal sample, or a saliva sample. You send it out, 95% of the time it's sent out the ones I showed you with the exceptions. You send it out to a lab, and hopefully, you get results in 24 hours. And you may remember in the summer, it was running five and six and eight and 10 days, and that's crazy. Today, I would say virtual all labs are running between 24 and 72 hours, probably most common to be 48 hours.
The reason Hawaii recommends that type of test is that is the perceived gold standard. It is the one that picks up the smallest number of virus. So, you say, "Well, that's good. If I want to get on a plane, I want to be a hundred percent sure." What's the challenge with PCR tests is they pick up so little virus that people could be positive, as a member of my family was for 38 days. He recovered in two weeks from COVID, but his test, his PCR test continued to be positive for 38 days. Was he contagious? No. Did he feel okay? Yes. Was he ready to go back to the world? Yes, but the PCR test continued to say they're positive so that's why people are worried about them.
Why do you say it needs to be in a CLIA lab? That I do think is the right idea, except for schools, which is a different issue, but it is remarkably easy for anyone to set up a lab in this country, which is why we have what I believe is appropriate regulations from the FDA and from HHS. And what CLIA says is your lab meets those quality standards and can be running tests. You don't want to have a test in a lab that opened up three weeks ago in somebody's garage because they think there's an opportunity vis-a-vis COVID. So hopefully, that gives you the balance. What I hope to see in the future is that airlines and states will accept the PCR test, or the NAAT test, and at the same time, potentially also accept two antigen tests to confirm that somebody is not positive.
Next question: Is on-site rapid testing for large crowds entering sporting events or concerts feasible or even a good idea?
I'm going to say a qualified, well, I'm going to say both yes and no. Do I think this sort of 15-minute tests, Abbott has said they are selling these in bulk today for $5, is this reasonable to do and wait 15 minutes for 5,000 people, 20,000 people going into a stadium? I think the answer is no. I think it takes too long. And these large crowd events, there'll be too many people who need to do it. And the time you have to wait, what's tricky about these tests is you have to wait 15 minutes, but you can't wait more than 25 minutes because then you lose the signal. And again, here's the signal just like I gave you on the other tests. One line is negative. Two lines are positive. The first line is control, and then the sample.
What I do think will happen is that we will have tests that are appropriate for large crowds. I think there'll be a few different types. One of them will be, there'll be a little bit of laughing here so I'm going to start with the fun ones. Scratch and sniff, and not "Here's a can of coffee. Can you smell it?" But, a test strip that is about this big, and you will be able to scratch it, and somebody will say, "Hmm, what does test number one smell like? What does test number two?" And they'll be simple things like popcorn, not esoteric as a thyme or rosemary, but it will be popcorn, it will be perfumes. Very basic. University of Colorado has already started to work on those. Those take less than a minute. If people are good at it, it takes a few seconds to go through.
The second thing is I think we will have COVID-sniffing dogs. Just like we see for drugs, these dogs are amazingly accurate at smelling COVID. They're also used for cancer. I'm not there yet with that, but I think for COVID, the same way we're using it for drugs or food, these dogs will be highly effective in large environments. I also think we'll have the possibility of seeing breath tests, and these will be small items kind of this size. You would blow into it, and it would go up to the cloud, or you would blow into it for two seconds, and it would go into an instrument for 10 seconds and say whether you're positive and negative. I think those are the kind of systems we'll use in large events. The challenge is they're not perfect, but the reality is just like the flu before the pandemic, if you go into a large crowd, there might be exchange of breath and fluids, so it's not all that different. But I believe that type of testing is cost effective and time effective for a large venue.
Question: Do the current COVID-19 tests work against the new variants?
The answer is absolutely yes, they do work. The antigen tests that I've talked about a few times, they focus on what's called the N protein. You've probably seen pictures, the cartoons of the virus and these things that stick out. They're called spike for spike proteins or the S proteins. The variants to date have been on these S proteins, but the antigen tests test on the N protein as nucleocapsid, and they are still just as effective. You will get a yes, whether you have the Wuhan strain, whether you have the variant from the UK, the South African variant, the Brazilian variant. What it won't tell you is it won't tell you what variant you have. It will say you're positive or you're negative, but they work highly effectively.
For the PCR test, virtually a hundred percent of those also work, and work effectively. There were a few at the beginning that were only looking at the spike protein, but that has changed now. You can be confident in the test, and the test developers are aggressively looking at mutations to ensure their tests still work. But to find out which variant you have, or what percent of the patients in the hospital have what variants, that requires a different kind of test called sequencing or next-gen sequencing or NGS test to say what variants. And right now, we're only doing that for maybe 5% of positive samples.
Next question: What messaging is effective for promoting or mandating testing?
Great question, and I wish there were some easy ones. I will say for the schools, and I'm the lead author of The National Covid-19 Testing Action Program, working with the Rockefeller Foundation. I'm also an advisor to the Rockefeller Foundation. And what we have done there strongly suggest, and I like to call these three steps to an effective process. Number one, mitigation. Wearing masks is still relevant and still hugely helpful. Number two, vaccination, which everybody hopefully knows all about and how effective that is. Number three is what I call information. Information is power. I like to say, I have a little, I don't want to say fun with it, but the three most dangerous words in this pandemic are "I feel fine," because we've never had a disease where maybe up to two thirds of people are completely asymptomatic. So, to say, "Don't worry, grandma. Don't worry, coworker. I feel fine," doesn't mean you don't have the disease and doesn't mean you're not contagious.
What are the three most powerful words? “Take back control”. And that's why we call our lecture series in the Rockefeller report, “Taking Back Control”. I think that, and it crosses any and all political lines, everybody wants control of their life. Testing gives you control of your life, and helps you prevent the transmission to others, and an outbreak. We've all had enough of this. Vaccination is going to make a huge change. The best vaccine we've ever had, 92%, but we still need to test. So hopefully, that's effective in doing it.
Very few schools and only a few employers that I know of, but I don't know the whole universe, have mandated testing, what they've done is used the carrot and not the stick. But there are some places where the risk of spread and high-risk people is so critical, while they're not mandating vaccines, they are mandating testing. And given how easy it is now to spit and get a swab, and just to be clear, these kinds of swabs, this happens to be a very large one, it's just the tip of your nose. The tests that go to the very back of your nose now are not common, and they've been all but replaced by the front of the nose. I'm just getting some more samples so I can show you. This is the front of the nose Q-tip, it's a longer Q-tip, and it just goes right in right here.
Next question: How should employers prepare for routine testing?
That is a great question. And also as I answer this question, I'm going to show you another sample. This one happens to be a SARS-CoV-2 test. In this case, a smartphone looks here and you can get an answer. And the same as all the others. Backwards here, this is the access where the sample goes in. You get this nasal swab, you dip it in and leave it in to some sort of chemical. It activates it, you drip the chemical into here, and then you get at the C or the T one line for control and two lines for test as positive. So, what do employers prepare to do? I think it's all about education and information, to tell them that you're not doing this in any punitive way. It's protecting everyone.
And even if most of your workplace are younger people, you don't want them to catch it, and then go give it to grandma. You don't want them to catch it, and give it to somebody in their family or otherwise who is immune-compromised and going through cancer treatment. So, to me, it's all about telling people that they have the power to do it, number one, they have the power in themselves, you know a lot of ads on that, to control this pandemic. Number two, I would tell them it's really, really easy and fast. It's not going to take up more than three minutes of your day to swab, to spit, and then wait for this result.
Number four, what I would also, well, we have, this is more of a business issue for leadership as to pay for the test. The cost of these tests has come dramatically down. Virtually, all of these are in the single digits. There is perception that they were $50, $75, a hundred dollars that they used to be. No longer the case. That is a critical aspect of it. And well, I'll leave it at there to do it, but, oh, I know. The last thing that I would add as an employer is emphasize the confidentiality, and that this is not something that you would target one part of the company or another. I think, personally, if I did a test, I would do it broadly, not for parts of the company, so everybody's in on it, and it's done quickly, and that you will keep the information confidential.
Next question: How often should we administer COVID-19 tests to employees?
The standard has been once a week for testing, but the FDA just last week said if you're going to use antigen testing, they're recommending twice a week. Personally, I think this is a good example. If virtually everybody's been vaccinated but you still want to do a testing program, once a week is probably fine, because you have that first level of protection. If you're in a high risk environment, a high prevalence community, or you're interacting with the public or people who are at high risk, cancer patients, elderly, you might want to go to twice a week, but I certainly wouldn't go more than that, and I think once a week would work.
One option that I would suggest is if you're going back to the workplace after a long hiatus, or even a long weekend where people were out and about, I might test everybody at the beginning and then, some employers are doing it 25% or 50% of people a week. They're only doing it twice a month, which is not a crazy approach. But if you did that, I would strongly recommend what I call and we're calling in the schools initiation testing before everybody comes back to ensure that you're not putting somebody positive back in the system right at the beginning.
Next question: How will COVID-19 tests work with vaccine passports, tracking positive and negative?
Well, I wish there was an easy answer here, and I know our country's tradition and history of confidentiality. I just talked about confidentiality within a company, but as all of you I'm sure know there's a lot of questions about whether we should even have vaccine passports. For the test companies, what they're doing, and I think this is an effective compromise. See how both of these have codes on them? QR codes. Once you do these tests, and not all the companies make them functional, but I'm told the FDA is being more aggressive about this and requiring them. When you do the test and you finish it, and you get, let's say, a negative, you scan it with your phone, and you will have something on your phone that says, "Mara Aspinall, you tested negative on April 6th." Now, for several of the companies, that passport, negative test result passport then expires. I can't get it on my phone four days later, or five days, or seven days later.
Now, clearly, you can take a picture of it, but it says - I'm sorry, I don't have time to show it to you - it says very prominently, “April 6th". So if you're looking at it, May 6, people know that if you are negative a month ago, you're not negative now. But, we all know that if there are deepfakes with all sorts of things. You could probably fake that. But, I think it's got to be a balance with trust in a small or even large workplace. In terms of tracking positives, that's also critical. What's key about the positive is that they are reported to the public health arena. And I believe that's why the FDA is getting more aggressive in ensuring that these have a barcode on them. For some of the manufacturers, you don't have to put in your social security number. Some of them, you don't even have to put in your name, but you have to put in your zip code so we understand what's happening in the community.
Last question: There were a lot of challenges with testing at the beginning of the pandemic. Are there any future challenges?
That's a great question. First of all, let me clear up that the challenges with testing at the beginning were two-fold. One is the initial CDC test had some real quality control issues. It's a pity, because at the beginning, everybody was very focused. Those were resolved very quickly. And with the CLIA test, with the FDA EUAs, there are no tests that I will say have quality problems. I'm also really impressed that the FDA has done two things. When there are challenges with the tests, it's not working quite right, or the instructions aren't clear, they put out a bulletin. They also revoke tests. There are tests, and you can see all of these at testingcommons.com or fda.gov, you could see which tests the FDA said, "You cannot sell it here. Even if we hadn't approved it, it is an ineffective, not safe test." That's the first safeguard.
The other challenges were the amount of capacity, and that has changed materially in a huge way. There should be enough tests for everyone. As I said, the PCR tests returning in 48 hours. What about the future? What I think is likely in the future is the testing reluctance that people won't want to be tested. They're done with it. Number two is testing confusion, because there are new test technologies coming out. And number three is the challenge of, I call it surveillance tests. I talked about them before for large concert venues, but there's also going to be wastewater testing for dorms, for big apartment building, where we're going to look like we did for opioids. Is there COVID-19 in the poop?
And that's going to be a challenge, because let's say you get in an apartment building. If you're not in a dorm, you probably can't require testing, or you get a zip code where you know there's COVID-19 around, can you follow up with testing? And I think that's going to be a challenge, but I think quality is good. Capacity is there. Cost is much further down than it used to be and will continue to go down. So we need to continue to educate to use tests and the right tests and the right way.
Thank you all very much. I enjoyed the opportunity. I wish I could see you, but I hope that you found this information interesting and useful. And again, thanks for the U.S. Chamber of Commerce Foundation for sponsoring this and giving us the opportunity to have this conversation, and hopefully, I answered a lot of questions. Goodbye, and stay well, everyone.