Money’s senior healthcare writer Elizabeth O’Brien explains the difference between diagnostic and antibody tests and the advances that newer iterations need to make when it comes to speed and accuracy.
Jeffrey Freedman: Hello and welcome to The RP HealthCast by RooneyPartners. I am your host, Jeffrey Freedman. We have been covering and reporting on the coronavirus pandemic now for about six months. One of the common themes is the controversy around COVID testing, and this comes especially as the CDC has changed their guidance again this week. The questions are, are we testing enough? On the other side, are we overtesting and who exactly should be getting tested? We are even questioning the accuracy of the test after hearing about so many false positives or false negatives, and the FDA has taken certain tests off the market very recently due to inaccuracies. So, it raises the question, are some tests better than others and is a rapid test less reliable than a lab test? Why does it take over a week in some instances to get the results from these lab tests?
So, aside from testing to see if you have the virus, there are antigen tests to see if you have previously had COVID-19 and if your body has the necessary antibodies to fight off the virus but there are all different types of antigen tests either on the market or come into the market that tests different biomarkers inside your body, and we are unsure if one is more accurate than the other. And then, even if you are found to have antigens, the question is, do they last, and if so, for how long? There were the first confirmed reports this week of three people catching the coronavirus for the second time. To make sense of all this testing information for us is our guest this week, Elizabeth O’Brien. Elizabeth is a senior writer for Money Magazine who covers health care and retirement. Previously, she was a reporter for the Wall Street Journal’s Market Watch, Smart Money, and other financial publications. Elizabeth, thank you so much for joining me today.
Elizabeth O’Brien: Thanks for having me, Jeffrey.
Jeffrey: Great. Now, before we dive into your reporting on testing in the coronavirus, I want to introduce you to our audience and discuss your career. So, for the past five years, you have been with money, and you have been writing about retirement and healthcare topics but for the past, I think you said 18 years, you have covered healthcare, retirement, financial issues, and that is after receiving a Masters in Journalism from Columbia University. So, I guess you have always known you wanted to be a journalist, right? How did you get into this?
Elizabeth: Well, yeah. You would assume. That is a fair assumption but I was always that kid who loved to write. I remember, I think I was in fourth grade, one of my classmates and a good friend and I wrote a newsletter about the neighborhood. My parent’s xerox did the work. It was sold door-to-door for ten cents. So, I was that kid growing up.
Jeffrey: You were that kid?
Elizabeth: I was that kid, but I do not think I had a sense then that I wanted to be a journalist because I do not think I had a great sense of this. I did not have any journalists in the family. I do not think I just recognized it as a profession until I got a lot older. So, I did not grow up wanting to be a crusading journalist, even though I am sort of a child of the Watergate era, but it sort of developed later in college for me the idea to pursue it as a profession even though I had always loved to write.
Jeffrey: Well, that is great. It is interesting that currently, your beat right now is healthcare and retirement. That is a huge, really broad territory to cover. So, how do you pick your stories? I mean, there is only one of you.
Elizabeth: Yeah, that is a good question. It is a very broad beat. I do also edit freelancer stories. So, I do occasionally have help from freelancers but even so, I definitely have to be selective in what I can cover because of bandwidth issues. So, it is what is a money story? What do I need to keep my readers informed of? Are there any upcoming deadlines to be aware of for Medicare enrollment, for example? We had a special August 31st deadline to roll back your RMD for this year if you did not want it. There are some specific things relating to the coronavirus this year. So, in any case, it is just a matter of being selective, and I have been covering this a while, so I do have a sense of what I need to jump on for my readership and what I maybe can pass on.
Jeffrey: Right. I mean, today’s topic that we are going to discuss is pretty specific, and you have been writing about antibody testing.
Jeffrey: Huge topic right now. Very, very important. Let us start out on a very broad level. Let us talk about the differences between antibody testing and COVID testing if you could explain the difference.
Elizabeth: Yeah, that is a good question. So, the COVID testing, the diagnostic testing, you might have heard the phrase “PCR test,” that detects the presence of an active infection. So, if you have symptoms, you get that test to see or even if you do not have symptoms, plenty of people are getting it just to see if they have the virus regardless of whether they are symptomatic or not. That is typically conducted with the swab in your nose. It almost tickles the brain. It goes way deep into your nose, and that detects the presence of an active infection. Whereas, the antibody test is typically conducted several weeks after you have recovered. That can detect whether there are antibodies. That is a blood draw and that detects whether there are antibodies in your blood that indicate that your body has battled the coronavirus. The antibodies are sort of the foot soldiers in this battle against the disease, and if there are leftover in your blood, that means that you have fought the infection.
Jeffrey: Okay. I got it. That is clear. So, the big question in hand and, at first, we are going to be a little rhetorical, right? But for the most technologically advanced society in the world, the United States, why are we having such a difficult time getting the testing right? And I want you to answer the question, but for the listeners, I want to give some history here. So, at the beginning of the year, the Food and Drug Administration discovered contamination in two labs at the Centers for Disease Control and Prevention or the CDC, right? Then, the CDC introduced to the public some flawed diagnostic tests. Then, that was followed with the FDA just allowing everything, permitting scores of companies to sell antibody tests, and many of these tests were just snake oil. They were plainly flawed. They were completely inaccurate. So, some of these shoddy tests, some are actually still in the market, but they have taken most of them off the market. Meanwhile, obviously, the coronavirus is still spreading. We do not have any national standards for testing. The basic things like who, when, how, these are changing on a daily basis still. It is almost embarrassing. It is certainly appalling, all the missteps. How is this possible?
Elizabeth: Yeah, I would agree. It is embarrassing and really appalling what has been going on. I do not have any special insight because I have not done a lot of in-depth reporting on the federal response, to be honest. I focused a bit more on the science end but from what I understand, the US was really caught flat-footed. The Trump administration disbanded the pandemic task force that would have been poised to assist in this kind of situation back in 2018. They got rid of that. So, we are caught in this reactive mode of trying to play catch-up, and really, we should have been on top of it from the beginning. I understand that that is what happened in South Korea. That country had retained a lot of the infrastructure that they used to fight SARS way back in the early 2000s. So, even though that was quite a while ago, they had retained that infrastructure in place. So, they were really able to get on top of this new coronavirus when it started to emerge. Whereas, the US was caught flat-footed and really had to play catch-up and really just was sort of inept. There is probably even more ineptitude on top of the sort of the late response for sure, and it really has been discouraging because it has really led to this unchecked spread that we are now seeing.
Jeffrey: Yes, and without these guidelines or an agency that was specifically in-charge, it is kind of scrambling to get back because as you said it was dismantled in 2018. So now, we get there. Now we have the test but another problem has been the delay in testing results. So, that is outside the government. That is kind of like the quest in the LabCorp, those people. So, there was an interesting story. Elizabeth Rosenthal who is the Editor-in-Chief of Kaiser Health. Now, she published in the New York Times a story about waiting 12 days before receiving test results for her son, and in her quote was “Coronavirus testing in the United States has been bungled in every way imaginable”. That is pretty powerful coming from the Editor-in-Chief of Kaiser, right? So, what is your take on this? Is it just the 2018 dissolution of that agency, or is it the inability to rebuild this?
Elizabeth: I think, about the testing delays, we have a capacity issue, and I remember reading that story when it came out and I was struck by it as well. I think, the federal government made testing and when we say testing, in her case, this was a PCR testing. So, active infection testing and she waited for too long to get those results, and the federal government made these PCR tests free in many cases for adults which is a good thing. You do not want to have to pay for them, but just so many people then rushed to take advantage of it, and the quests of the world cannot process them in time. So, we have these massive delays in getting the PCR, the diagnostic test results back, and if you wait 12 days to get your results back, you might as well not have bothered at all. It is almost meaningless to get your results back so late, so it is really a shame.
Jeffrey: Absolutely agree. Every program that I am seeing, and school is starting, so we are trying to think if we had a federally mandated policy for schools or a national policy, how would that help? From personal experience, I know the University of Tampa does not do any testing. I know the State of New York, the SUNY schools, they test once to allow the kids into the dorms for the first time.
Elizabeth: Oh, interesting. Okay.
Jeffrey: And then you have schools like Tufts that test each student twice a week.
Elizabeth: Oh, wow.
Jeffrey: So, it is across the board. So, Margaret Bordeaux is the Research Director of the Program in Global Public Policy at Harvard Medical School and she wrote a couple of weeks back. She writes, “As summer turns to fall, slow and fragmented testing will fatally undermine the reopening of schools and universities whose plans are predicated on quickly identifying outbreaks in suppressing spread. Testing for millions of students will feed into an already failing national system”. Now, you talked before about the bottleneck of all the tests. Now, all these kids are going to school all at the same time right now. I have to imagine that is increasing the bottleneck. What are your thoughts, and what do you think we are going to see?
Elizabeth: Yeah, I would agree with you. I do not think we have gotten to the point where we can know where it is streamlined in and if the people can get tests back in a reliable manner to act on them, and it really is a shame because, as you said, the safe reopening is sort of predicated on having this infrastructure in place and it is really not. It is really not reliably in place to process these tests in time for students and faculty and administration.
Jeffrey: Yeah, and another thing that you mentioned before. You mentioned South Korea, how they still had their plans in place and they did a great job with their testing. One thing also that they have kept in place and have built, I should say, off of this has been contact tracing.
Jeffrey: Now, without rapid test results, contact tracing is impossible, is not it?
Elizabeth: Yes, it certainly becomes much more difficult because let us say you have a diagnostic, you have a test, and you wait a week or even two weeks to get those results, then you get back positive. Well, you have to think maybe in the subsequent two weeks you were waiting for results, you were in contact with that many poor people, and I guess the point of contact tracing is you have to then go back to everybody who you were in contact with and say, “Hey, I might have exposed you”, and then they have to reach out to their contacts and it is sort of this web of all the potential exposures, but yeah, it just becomes that much more difficult if you have to wait forever and have that many more potential people to have to reach out to. Not only that, but let us say you have to wait two weeks to get your results. Well, maybe you were negative. The diagnostic test is a snapshot in time. Are you infected or not at the moment of the test? Well, maybe you were negative at the moment of the test but you subsequently got went to a party and you got infected but you get your negative result back a couple of days after you go to that party. Well, that could lead you into a false sense of security because you are not actually negative. You have subsequently gotten infected but at that snapshot in time when you had your diagnostic test, you were not infected. So, there are so many problems with these delays in testing results.
Jeffrey: That is a fantastic point. Absolutely. All right, let us turn then to antibodies. Antibody testing. So, at the time you reported, there were 14 antibody tests on the market and some of these tests have been criticized for reporting false positives and false negatives. Now, why do not you explain what that means? What is a false positive, false negative, and is there a federal range where it is acceptable for these tests?
Elizabeth: Yeah, so the accuracy… Well, actually before I get into what makes an accurate antibody test, let us say a false positive as it sounds is when the test says you have antibodies in your blood but you actually do not. It picked up on something that is actually not. It registered something that was not there. So, it is a false positive. Whereas, a false negative, the test did not pick up on the presence of antibodies that were actually in your blood. They failed to detect the presence of antibodies, and we have been getting a lot of these because, especially in the beginning, these tests were coming out with wildly varying quality, some not very good at all and the accuracy of an antibody test depends on two factors. It is called the sensitivity and the specificity. The sensitivity gauges, whether the test can pick up on antibodies if they are present, and then the specificity is whether the test can detect the difference between the antibodies for the coronavirus versus the antibodies for the new coronavirus which is SARS COVID-2. That is the antibodies for that virus that causes a coronavirus versus other coronavirus. SARS was a coronavirus. MERS was a coronavirus. So, your body could have other coronavirus antibodies but not this specific one. So, if the test is not specific enough, it could pick up on the wrong antibodies. So, basically what you want to have on both of these two factors, the sensitivity and the specificity, you want it close to a hundred percent as possible. You want them in the high 90, in a 99%, 100%. If they are 100% specific and 100% sensitive, then that is a really accurate test but we have had tested especially the early ones that are nowhere near that, and they are thrown off a lot of especially false positives which can lead people into sort of a false sense of security.
Jeffrey: Right, and these are, as you said earlier, these are the blood tests, not necessarily the nasal swab test.
Elizabeth: Yes. These are the blood tests. Yeah. It is not a prick. They take a whole little while and they test the presence. They test for the presence of these antibodies.
Jeffrey: Okay. Now, from a biology point of view, there are many different aspects of this virus.
Jeffrey: And there are different tests that test for different parts of the virus. So, is one better than the other? If you find one, you have the other? Or if you are testing for one and it is not there but you could still have it?
Elizabeth: My understanding is that if you have one, you probably have the other. In other words, the immune response is a coordinated response. It is like the virus is the invading army, the immune response is the cavalry that comes in the different parts of that. I was talking to an immunologist yesterday who said that the first antibodies to rush in at the point of infection or kind of crappy, they do not stick that well, they are not great but they are fast so they try to hold off the invader until the more specific antibodies can come in and really attach, and then if the virus exceeds the antibody’s capacity, you have got some memory B cells to come in and then the T cells come later. So, it is this whole coordinated response. It really is quite amazing when you think about it, and for my understanding, if you have one of these immune pieces, if you have the T cells, you have got the other stuff like it all kind of comes. It all works together and they all eventually become present in your blood if you are fighting an infection.
Jeffrey: All right, and that is important. That whole jumbled soup that will call it. Now, these tests also test the number of antibodies in your blood, and the higher the antibody you have, the safer you are, correct?
Elizabeth: Well, that is what they had thought but it is interesting. This doctor I was talking to yesterday, his name is Dr. Deepta Bhattacharya. He is an Immunobiologist at the University of Arizona, and he recently did a test. It was really interesting. Initial tests had said– studies, I should say, had found that the presence of antibodies after you have recovered from the coronavirus several months past, your levels of antibodies fall and that was presented in some accounts, some reports of these studies as an alarming thing. “Oh, no our levels of antibodies go way down”. So, we are less safe but this doctor I talked to yesterday, Dr. Bhattacharya said, “Actually, it is not alarming. It is to be expected because the body cannot sustain that kind of really intense immune response forever”. The cavalry rushes in and they do their job, they fight the infection, and then when the threat retreats, they also retreat but they do not completely go away. They stay at these low levels and then if you get reinfected or if the virus tries to enter your body again, they jump, they spring into action. So, it is not necessarily a bad thing to have low levels of antibodies. They are just sort of lying and wait to be activated again if there is a future threat.
Jeffrey: Yeah, that makes sense. I mean, we heard this week, it was reported that there were three patients so far, confirmed reports that three patients have gotten the coronavirus now for the second time but all three of them are almost asymptomatic so it did not come back as hard. So, these memory cells make a lot of sense to me.
Elizabeth: Exactly. Yeah. Yeah, and apparently the T cells that hang around after the infection are not going to help you from getting reinfected but if you do get reinfected, they are going to help you from getting really sick. They are going to help mitigate the infection. So, yeah, they definitely are waiting to be reactivated in the event of a future threat.
Jeffrey: Got it. Now earlier, we talked about the lack of COVID testing, virus testing, but I think you wrote about already. I have definitely been reading the FDA granted emergency approval to two companies, Quidel Corp and Becton Dickinson, for the production of rapid antibody tests. Both companies reporting difficulty ramping up production. Can you talk about this? Is it hard? Is this something new? They have been doing this. This is what they do.
Elizabeth: Yeah. That is an excellent point. This is what they do so you would think that they would be able to marshal the resources in the event of a national crisis, which we indeed are in the middle of. Now, to be honest, I have not reported on this issue. The Wall Street Journal has, and their reporters have said that these two companies are having trouble sourcing needed materials like collection swabs and testing kits and they also, actually, not only do they make the tests, but they make this box that analyze the tests, and that is a good thing because if a doctor’s office or a school can get their hands on one of these analyzers, they can process their own samples and they are not sending them out to some big processing center that is going to get bottlenecked. So, it is good if you can get your hands on one but I guess they are having trouble ramping up production to make enough of them, and to the extent that they are able to make them. My understanding is that nursing homes are getting them first. So, the priority is going to the nursing homes, and there is less to go around for other places. So, why this is happening? I could not tell you.
Jeffrey: Yeah, it is a mystery to all of us. Great thing. You have one job. All right. So, last question. I just read the whole back-to-school thing. The Los Angeles Schools District, the whole LA school system will provide, now I will quote what they said, “Regular testing and contact tracing for every single student and employee in the district”. Now, that is over 675,000 students and teachers. Talk about a backlog and bottleneck.
Jeffrey: Let us talk about what are they going to be testing for. How do you think they can make this happen especially when nowhere else in the country has been successful in mass testing? How can they go out and raise the flag saying that is what they are going to do now?
Elizabeth: Yes. It is a very ambitious program, and my understanding is that the school district started remotely so they are not putting this into place immediately, but they want to get it into place for the eventual resumption of in-person learning, right? So, they are gonna be rolling it out over the coming months, and I do not know how they are going to do it. They, I think, are going to be using, this is going to be another diagnostic test to detect an active infection, but I think I was reading in the LA Times, it is going to be a saliva test. So, not this nasal swab. It might be a saliva test that you can administer yourself. So, potentially that takes away one element of the bottleneck. If you are able to get the test into the hands of people, they do it themselves but there are still plenty of other stages along that could potentially get bogged down. Those samples need to be collected. They need to be processed. The results need to come out. They are not doing it alone. They are doing it under the oversight of epidemiologists from Stanford UCLA Johns Hopkins, so they got some pretty smart minds looking over things. So, with any luck, they can make it work. If they succeed against all odds, that could be a great model for other systems.
Jeffrey: That would be that would be a fantastic model and one I would love to roll out nationwide. Elizabeth, thank you so much. This has been really, really educational, entertaining, interesting and you have been fantastic. I appreciate this.
Elizabeth: Well, thanks so much for having me. It has been fun.
Jeffrey: We hope you enjoyed this week’s podcast. If you have any questions comments, or future story suggestions, please reach out to us on social media. Thank you, and we hope you enjoyed the RP HealthCast.