Answering Your Questions About Testing

Stan Bunger
July 29, 2020 - 1:59 pm

    As we continue to navigate these unprecedented times, KCBS Radio is getting the answers to your questions about the coronavirus pandemic. Every morning at 9:20 a.m. Monday-Friday we're doing an "Ask An Expert" segment with a focus on a different aspect of this situation each day.

    Today we focused on COVID-19 testing with Caroline Savello, chief commercial officer for Color, a Bay Area health company running many of the region’s testing sites.

    This area obviously has been an area of great concern to people; we all know now that it's an important part of the nation's response. I wonder if you'd walk us through Color's transition, in many ways, from a slightly different business that you were set up to be in, into suddenly being in the middle of COVID-19 testing.

    Yeah, absolutely. I think everybody back in that March time frame was just thinking, how can we help? And our roots were really in providing very large scale, very technology-driven testing access to large populations. It wasn't COVID testing, but it was still testing. And we saw what was happening and really over the course of, effectively, a weekend decided that we were going to mobilize the company to try to support. We went and we built and constructed a high throughput automated COVID-19 testing lab right in Burlingame, right next to our existing headquarters, and we repurposed a lot of the company's infrastructure and our software to be able to offer this to really large populations of people and just try and have an impact.

    Those of us who go get tested understand: there's a swab in the nose and then there's some results. There must be a lot that goes on in between. What is the part in between?

    Yeah, so the way we think about it is, how do you, very simply, get individual patients to be able to sign up for, register for a test, get a sample collected and have that process as quickly as possible? And then have the results get to them as quickly as possible. So the way that we have tried to set up our entire system and process is super simple for anybody to be able to register for a test versus having to wait for an appointment, wait for a doctor's appointment. Come have a very simple sample collected - which is at this point in all of our work in San Francisco, in the Bay Area is just a nostril swab - and then have those samples actually be delivered to our lab in Burlingame, loaded into our machines. There's RNA extraction steps where we extract the viral RNA, if it's present, from the sample. We run the testing, which takes a number of hours, and then that data actually feeds into a report that then is texted or emailed to every individual with their results.

    So what happens in the middle? There are a lot of steps in that process that happen in our lab. But effectively, it takes about 6-8 hours for a sample in total to go from getting loaded on our machines to a sample reading out.

    And obviously this is something that happens in the physical world. The sample has to go from the collection location to Burlingame, in your case, to be run. So there are issues around that. I think we all saw the Major League Baseball mess a few weeks back where they tried to get everything to Salt Lake City on the Fourth of July weekend.

    Yeah. So you know, what we have really believed since the beginning is you have to have results quickly for it to have an impact. So the entire team, of the logistics of that, has to be really tight and integrated. We have to know where samples are at all points in the process. Everything we do is bar coded, we know exactly where things are from the point that somebody's signing up for an appointment to the point that their data is getting back to them, their results getting back to them.

    And we've always focused on turnaround time. We've been really trying with all of our public health efforts in the Bay Area to make sure that tests are resulted within two days so that there can actually be an impact on public health. People know if they have it and can isolate quarantine appropriately.

    Fair enough. Let's get to questions, and we've got a bunch of them here. People are obviously very curious about everything around testing these days. These have been sent in to askus@kcbsradio.com.

    First one: I'm an essential worker and have done three tests at the Embarcadero testing site in San Francisco, all negative. Tests one and three involved the test takers sticking the swab up my nose and twirling it around for 10-15 seconds, leaving my eyes watering and nose feeling funny. Second test: just swabbed lightly inside my nose, no aftereffects. Why the difference? I have another test coming up. Can I ask it to be done like the second one?

    It's a good question. There actually have been changes in how we collect samples over time since we started and that's, you know, as the science developed here, as automation and technology developed. So very early on when we started our efforts back in March and April, all of the samples being collected were nasopharyngeal swabs, the ones with the very thin swab that go all the way back up the nostril, the nasal cavity, into what people have referred to as the back of the brain. Those are likely the ones that left the eyes watery and the nose feeling funny.

    We've actually since been able to move to a much less invasive sample collection type based on data that we've gotten over time. And that's really just a simple swab in both nostrils twirled around in the near upper part of the nose. It's a lot more comfortable for people. We've actually shifted all of our work to that, as have many, many testing companies and clinicians. I think it's actually really important that people are not worried about getting a test so that we can actually get this pandemic under control. So that's been really part of how we've tried to design our process as well.

    The next question wants to know in general what to expect after you've signed up online, because that's how the process works. This person's going to the 7th and Brannan site next week.

    Great. Yeah. So you've signed up, you have an appointment confirmation. We try to make it super efficient and simple from there. So you drive to the site or walk to the site. There's basically two stations: you're checking in at the first station, holding your ID up to the window or up to an individual, all proper social distancing and infection control protocols in place. And what they're running is Color software on an iPad, and they're checking you in - we have that data preloaded - they're checking you in as somebody who's registered and you're driving or walking to the next swabbing station. And at that point a clinician will administer the non-invasive nostril swab, put it in a tube and then they'll hand you a card with a barcode on it. And that barcode is how you'll be able to access your results within 24-48 hours, typically, sometimes up to three days. You'll get a text message or an email from Color saying your COVID results are ready, and with your barcode and clicking on that link, you'll be able to go and view your results, which will say very clearly what the test result was.

    Next question, and this is not specific to Color but obviously everybody wants to know the answer to this: why are some test results taking so much longer than others?

    That is a really good question and something that has really affected the pandemic response in a lot of regions. Every lab will take a different philosophy to how they want to manage the volume and the testing. We have again been really trying as much as possible to make sure that our test results come back in a time period that makes him useful. Other labs, I think, have two things sort of happening to them. One is they can't control the amount - they're basically over-committing in terms of the volume that they can process. They're getting samples that are coming in from everywhere, there's too much coming in and they can't handle the volume.

    The second, and I think this is actually more important, is a lot of them don't have a fully integrated, automated process. When we get a sample coming in, again, it's fully digitally barcoded, we know where everything is and we've built all of the automation to be able to process these simply. Our lab doesn't take paper, as one example, and many others get really, really laden with the administrative overhead and having humans actually have to process a lot of different types of samples, a lot of different types of order forms that are coming in with samples. And that really causes a lot of bottlenecks in the process that slows down the time it takes to return a result.

    And this next question maybe you've already answered a good part: what are the biggest hurdles in testing? Personnel? Materials? Lab throughput?

    I think one of the biggest hurdles actually has been that a lot of our efforts in testing in this country have not been thought of very systematically. The lack of integration that I've been talking about really does cause a lot of bottlenecks. And we actually, for instance, have just received a new FDA authorization to allow unmonitored testing. This actually really helps with another one of the bottlenecks, which is clinical monitoring, clinical administration of samples, having to have a health care professional actually be at the point of administering  a sample collection. And I think those are the types of things where we've been trying to be very systematic about breaking down all of those bottlenecks. And I think the country hasn't necessarily thought exactly the same way.

    Is it safer to conduct testing outdoors versus indoors?

    That's another good question. Outdoors is, given the airflow, obviously better just in general. But there's a lot of efforts going into the retrofitting of indoor spaces to ensure that there's appropriate airflow as well. And I think that what we've seen - and this is one thing I am not an expert on - is that infection control put in place in indoor areas really can help and make it just as safe as outdoors.

    How often should essential workers get tested if they don't show symptoms and the first test was negative? I did my first test over a month ago.

    Unfortunately, the reality of this virus is you can contract it at any time. You can become infected by any kind of exposure event. Over the course of a month, especially as an essential worker, you may have a lot of interactions with individuals where you may have had possible exposure. A test result from a month ago is unfortunately no sign that today you haven't been infected.

    We actually have done a lot of modeling of this kind of work and basically very routine surveillance, being able to test very frequently, actually really helps with the pandemic control. Obviously, there are a lot of things that feed into that: how easy is it to access, how quickly can you get the test results? I don't know what the Department of Health's recommendation is on this, and I would defer to them in the context of San Francisco. But a monthly test doesn't unfortunately guarantee that there's no infection present today.

    What is the time frame between being infected and testing positive? In other words, if I were infected with COVID-19 on the same day I was tested, how soon would it take for my test results to come back positive?

    The World Health Organization has said that there's a couple of key points in time. So the day that you were exposed to the virus, you will never get a positive test result. So there's always a lag. About three days after symptoms start, you almost all of the time would get a positive result if you have been infected. The middle period of time is still relatively unknown. It can be a week, it could be a few days. It really depends on how the virus is manifesting.

    Can your expert offer advice on where timely testing and results are available for me if I'm willing to pay out of pocket? I've heard that many insured services can take over a week for results, making them pretty useless.

    I think that the out-of-pocket payments right now are not actually significantly different. A lot of the underlying lab infrastructure actually is the same for many of those services that are offering what I would call "patient initiated testing." So the ones that you can actually request online and get delivered to your house, they're actually a lot of the same lab infrastructure and similar turnaround time. I think that where people should be definitely looking is a lot of the public health infrastructure in the Bay Area. We're working in San Francisco, in Alameda County in Marin County and those services often are really trying to make sure, whether it's with Color or with other labs, that those results come back very quickly.

    I have a whole bunch of questions here around accuracy so let me just lump them together. What is the current standard? How confident should people be in either a positive or a negative result?

    So this does range a bit by different types of labs and different types of tests, so I'll speak to at least our testing. The accuracy is very high, but the accuracy also depends over time, over that period of infection, based on how the virus is sort of presenting in your body over time. What happens over time is, as the virus spreads, it becomes easier to determine and more accurate to determine if you actually are infected. That said, the accuracy of our testing is basically gold standard. It does depend on sample collection, it does depend on the virus within you, but it is as accurate as it can be when you're running this kind of technology that's been authorized by the FDA.

    There's other testing out there such as the antibody testing and some of the newer testing technologies. One of the ones that's been talked about a lot recently is antigen testing and the sensitivity of those, the accuracy of those is lower. Information is as good as it is at any given point in time and that's why we always reiterate CDC guidelines around, if you have symptoms or you are feeling unwell, you should continue to isolate yourself, even in the case of a negative test results just out of an abundance of caution.

    I'm a nurse, I'd like to get tested, do I need a referral for my doctor? Can I go somewhere on my own? How much does it cost? I have Kaiser coverage, how do I find out where to go in Marin County?

    Good question. So I think there's a number of options, one is Kaiser itself. I know that Kaiser has been offering testing for its members. But the second is, a lot of the Bay Area counties that we're working with, including Marin, have set up these public testing health infrastructure sites. We actually just opened one in Marin County last week. The Marin County Public Health website will actually direct you to the Color Marin County site that is operating at Marin Center, and that has testing availability for essential workers and any individuals who are symptomatic. You can sign up very easily online, come to the site, have a sample collected, the test is being run at Color and it's resulting back to you. So those are two options for you as well.

    I can get nose bleeds and worry about driving in for a test and having to drive home with a nosebleed. Is there an alternative to this? 

    A lot of the testing in the Bay Area has been a sample collected from the nose. There are some tests out there - ours is not one of them - where you can submit a saliva sample. I don't actually know across the Bay Area specifically, where that is accessible. There are some options online where you as an individual can go online and order one of those, but I don't know offhand any publicly accessible saliva testing in the area.

    The next question touches on that too and wants to know whether your technology at Color could be adapted to point-of-care testing at a doctor's office and/or an at home test like a pregnancy test? And could saliva be used as an alternative to the nasal swamp?

    So we actually, with our recent FDA authorization, we are able to provide testing at home, unmonitored. That will be starting downstream, but what we're really working on with that is really to provide that as a public health tool as well. The point-of-care tests are quite different, but our technology, what we've been trying to do is make it as accessible as possible to large populations, even while we still are running everything in our facility, in our lab in Burlingame.

    My sons and I had pneumonia in late February, too early to have taken a COVID test. I took the antibody test two weeks ago; it came up negative. Will there be a test any time soon for T-cells or other long term immunities?

    I think that the way that testing technology is evolving, I think there's gonna be a lot of new introductions of that type of technology over time. I don't know specifically about whether or not long term immunity is one that will actually be very testable in any relatively short period of time. I think that a lot of the focus right now is on, how do we identify as quickly as possible as many infectious cases as possible so that we can isolate and actually manage the public health outbreak that's occurring?

    Everybody is curious about the swab Caroline, I have to tell you. You're probably well aware of that.

    If I ever feel the need to get a test, what's the most accurate test I can get? I'd like to avoid the unpleasantness of the deep nasopharyngeal swab, especially if I can get accuracy. Is there any difference in accuracy between the different ways of gathering the sample that anybody's noted?

    Yeah, we get that question a lot. Effectively, the FDA and the CDC have said that a nasopharyngeal swab or a nostril swab or what's called a mid-turbinate swab, which goes partially up the nose, that all of these are perfectly acceptable sample collection types. And I think that's really important, because I think that should give people a lot of confidence that a less invasive nasal swab still will help perform a very high quality, high accuracy test and be less invasive.

    And I think that there are always trade-offs in these decisions. We have not seen any meaningful impact on accuracy from using a less invasive swabbing type. And it really does help change how people view testing. We actually want people who are feeling symptomatic, who may have had an exposure event, to understand if they have the virus. And if concerns or fear of sample collection will prohibit them from doing that, that's not good for anybody and that's not good for public health.

    I live in the Las Vegas area where there's a backlog of 16,000 tests awaiting lab processing. I had my second test on July 20; received results today, so that's nine days. Why is it that athletes get tested and get results quickly while the rest of us have to wait for results? Am I any less important or valued than a baseball, basketball or hockey player?

    I know, this is a really tough topic. That's why we've been dedicating so much of our efforts to public health in the Bay Area specifically, and making sure that we actually are providing really fast results for everybody, regardless of who they are or where they come from. I think that this is where the state governments, county governments should really be trying to work with labs for public health purposes that are committed to a really fast turnaround time, which will help not only individuals feel safe and secure, but also help public health, schools.

    How replicable is this recipe that you've cooked up at Color? The whole process you talked about: the paperless part, the lab back-end, all of it. Is this something that others could be doing or is this stuff that you folks have figured out on your own?

    I think others could be doing it, and we work nationally and we've put this in place across the country. I think it's really a philosophical thing of how different companies and different labs approach the process, and really being focused on efficiency and integration. I think others could be doing this and we would be happy to help, I think. There's a real opportunity to add this kind of infrastructure to, for instance, state level efforts in the state of California or Bay Area-wide efforts.

    This interview has been edited for clarity.