Ask An Expert: COVID TESTING

Excerpts and edited notes for this blog were referenced from an “Ask An Expert” KCBS radio station 740 FM segment on July 29th, 2020 at 9:20 AM sponsored by Stanford Health Care, hosted by Stan Bunger. The following blog is presented for viewers to validate, accept and/or decline its content and findings on their own.

As we continue to navigate these unprecedented times, KCBS Radio spoke with Carolne Savello, chief commercial officer for Color, a Bay Area health company running many of the region’s COVID- 19 testing sites.

Ask An Expert

1. Stan: 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.

Caroline:  Back in March everyone was thinking, how can we help? Our roots were in providing very large scale, technology-driven testing access to large populations.  Although it was not COVID testing,  it was still testing.  We saw what was happening and over the course of a weekend, we decided to mobilize the company to try to support the effort.  We built and constructed a high automated COVID-19 testing lab  in Burlingame,  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 large populations in order to have an impact.

2. Stan: 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?

Caroline:  Our thinking process was, how do you setup a system for individual patients to be able to sign up for a test, register for a test, collect a sample, process the test, and provide results, as quickly as possible.  We tried to set up our entire system and process to be super simple for anybody to be able to register for a test without having to wait for an appointment or wait for a doctor’s appointment.  Our sample collected is simply just a nostril swab, which is at this point performed in all of our work in San Francisco and in the Bay Area.  We have those samples delivered directly to our lab in Burlingame and loaded into our machines.  Our machines 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.  Effectively, it takes about 6-8 hours for a sample in total to go from getting loaded on our machines to a sample readout.

3. Stan: 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.

Caroline:  Since the beginning we believed that quick results would have an impact. So the entire team process and the logistics 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, and when their results get back to them.

Our focus has always been on turnaround time. With all of our public health efforts in the Bay Area,  we have been trying 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.

4. Stan: 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 [email protected]

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?

Caroline: It’s a good question.  Since we started, there have been changes in how we collect samples due to developments in science,  automation and technology.   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 have since been able to move to a much less invasive sample collection type based on data that we’ve gotten over time. That is just a simple swab in both nostrils twirled around in the near upper part of the nose. It is a lot more comfortable for people.  We have shifted all of our work to that, as have many testing companies and clinicians. It is really important that people are not worried about getting a test so that we can actually get this pandemic under control. That has been  part of how we have tried to design our process as well.

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

Caroline: Great. So you’ve signed up and 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 are basically two stations:  You check-in at the first station and hold your ID up to the window or up to an individual with all of the proper social distancing and infection control protocols in place.  They are running  Color software on an iPad, and they are checking you in.  The data is preloaded.  They are checking you in as somebody who has registered.  Then you drive or walk to the next swabbing station.  At that point a clinician will administer the non-invasive nostril swab, put it in a tube,  and then they will hand you a card with a barcode on it. That barcode is how you will be able to access your results within 24-48 hours, sometimes up to three days.  You will 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 will be able to go and view your results, which will say very clearly what the test result was.

6. Stan: 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?

Caroline: 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 as to how they want to manage the volume and the testing.  As much as possible, we have been  trying to make sure that our test results come back in a time period that makes them useful.

Other labs, have two things happening to them:

1. They cannot control the amount of testing.  They are basically over-committing in terms of the volume that they can process. They are getting samples that are coming in from everywhere.  There is too much coming in and they cannot handle the volume;

2. More importantly, is a lot of other labs do not have a fully integrated, automated process.  When we get a sample coming in, it is fully digitally barcoded. We know where everything is and we have built all of the automation to be able to process these simply. Our lab is paperless; whereas, many other labs are laden with the administrative overhead and with the task of having humans process a lot of different types of both samples and order forms.  That causes time processing bottlenecks to return a results.

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

Caroline:  One of the biggest hurdles is that a lot of our efforts in testing in this country have not been thought of very systematically. The lack of integration causes a lot of bottlenecks. For instance, I have just received a new FDA authorization to allow unmonitored testing. This  helps with another one of the bottlenecks, which is clinical monitoring and the clinical administration of samples of having to have a health care professional actually be at the point of administering a sample collection. Those are the types of things where we have been trying to be very systematic about breaking down all of those bottlenecks.

8. Stan: Is it safer to conduct testing outdoors versus indoors?

Caroline:  Outdoors is, given the airflow, obviously better just in general. But there is  a lot of efforts going into the retrofitting of indoor spaces to ensure that there’s appropriate airflow as well. I am not an expert on whether infection control put in place in indoor areas really can help and make it just as safe as outdoors.

9. Stan: 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.

Caroline: 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 have done a lot of modeling of this kind of work and basically very routine surveillance. The ability to be able to test very frequently,  really helps with controlling the pandemic. 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 does not unfortunately guarantee that there’s no infection present today.

10. Stan: 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?

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

11. Stan: 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.

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

12. Stan: 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?

Caroline: This does range a bit by different types of labs and different types of tests, so I will 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 presenting in your body. Over time as the virus spreads, it becomes easier and more accurate to determine if you actually are infected. That said, the accuracy of our testing is basically the gold standard. It  depends on sample collection and it depends on the virus within you. It is as accurate as it can be when you’re running this kind of technology that’s been authorized by the FDA.

There is  other testing, 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. 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.

13. Stan: 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?

Caroline:  There are a number of options and one is Kaiser. I know that Kaiser has been offering testing for its members. The second is, a lot of the Bay Area counties that we’re working with, including Marin, have set up public testing health infrastructure sites. We opened one in Marin County last week. The Marin County Public Health website will 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 and have a sample collected. The test is run at Color and its results sent back to you. Those are two options for you.

14. Stan: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?

Caroline: 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.

15. Stan: 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?

Caroline: With our recent FDA authorization, we are able to provide testing at home, unmonitored. That will be starting downstream. We are trying 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.

16. Stan: 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?

Caroline: The way that testing technology is evolving, I think there is going to be a lot of new introductions of that type of technology over time. I do not 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?

17. Stan: 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?

Caroline: 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.

There are always trade-offs in these decisions. We have not seen any meaningful impact on accuracy from using a less invasive swabbing type. 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. 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.

18. Stan: 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?

Caroline: This is a really tough topic. That is why we’ve been dedicating so much of our efforts to public health in the Bay Area specifically, and making sure that we 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. This will help not only individuals feel safe and secure, but also help public health, schools.

19. Stan: 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?

Caroline: Others could be doing it. We work nationally and we have put this in place across the country. It is really a philosophical thing of how different companies and different labs approach the process, and being focused on efficiency and integration. I think others could be doing this and we would be happy to help. There is 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 and conciseness.

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