UC San Diego Health Launches Coronavirus Antibody Testing

Speaker 1: 00:00 Today. California governor Gavin use him, challenged all Californians to consider ways they can volunteer to help their communities survive the covert 19 virus. Speaker 2: 00:09 It's all about a state of mind from our zoomers to our boomers. Uh, w regardless of your age or stage in life, we want you to volunteer. We want you to participate. Speaker 1: 00:20 Governor Newsome asked all Californians to check into a new website, Californians for all.ca.gov he said tomorrow he will talk about more detailed guidelines on how to start loosening the stay at home restrictions. He'll give an update on what he called the roadmap to recovery, giving an update on progress on the key areas that he laid out last week that'll be necessary before we can reopen the economy. He said although the curve is flattening, the numbers need to come down and though testing is ramping up, it is still nowhere near where we need it to be. To lift all restrictions as the pressure to lift covert 19 restrictions mounts. A key stumbling block is the lack of reliable testing. Two kinds of tests are ramping up. One to see if someone has the virus. The other antibody testing shows of a person has been infected and recovered. Recent studies analyzing antibody testing, one in Los Angeles, the other incentive Clara County, so just hundreds of thousands more people could have already been infected than we knew. UCS D is about to launch its own antibody testing program and with us now is dr Ronald McGlone, director of UC San Diego center for advanced laboratory medicine. Dr. McMillan, thanks so much for joining us. Speaker 3: 01:34 Thank you for inviting me to join you today. Speaker 1: 01:36 So just start off by explaining to us the difference between the antibody test and the coronavirus diagnostic test. What exactly are you looking for with the antibody tests? Speaker 3: 01:46 So the antibody tests looks at proteins within the blood that are generated by the body's ho host immune system in response to the [inaudible] virus. So the, this is your body's response to a viral infection or current or past. Speaker 1: 02:04 So one test is whether you have the virus and the other one is whether your antibodies have launched to attack it as it were. Speaker 3: 02:11 That's correct. You start seeing antibodies appearing in the blood between five, seven days after you have been exposed. Speaker 1: 02:19 Does the presence of antibodies to the virus actually indicate that a, that a person is now immune? In other words, that they're safe to go about their business. Speaker 3: 02:26 That's not been proven yet for the COBIT 19 virus. It's assumed because in many other infectious diseases that is the case. But that has not been firmly established. Speaker 1: 02:40 So why, why then if it doesn't protect us from re-infection, why have antibody tests become such a focal point in the response to the coronavirus pandemic? Speaker 3: 02:49 Remember a lot of people who have, um, an expose to the SARS Coby two or covert 19 virus are asymptomatic. So having the antibody test tells you if you've been recently exposed or if you were exposed sometime, you know, a month or two ago. That's particularly important. And as far as even looking at and monitoring our health care workers, you know, in terms of being able to come back to work or, you know, working with patients closely on a day to day basis. So we're, we're not only going out and looking at antibodies in the community, particularly one area that's very clearly a, uh, a target that we're looking at in the counties looking at is, uh, you know, going to skilled nursing facilities where, uh, the prevalence of coven 19 virus is fairly high and seeing as far as the residents and the employees there to whether to what extent they've been exposed. Speaker 1: 03:47 So you're planning to start with healthcare workers in your testing program, is that right? Speaker 3: 03:52 We've been testing for about a week now. We are expanding to do testing to our healthcare workers also to our patients. Speaker 1: 04:00 Let's talk for a minute about the results from the LA and Stanford studies. They've caused a bit of an uproar because in LA, for example, their study found that over 400,000 residents may have had the virus and then recovered. But at the same time, the, the County in LA had only reported 8,000 positive cases from coronavirus testing. So that's about 50 times more people infected than, than we thought. Does it suggest that the fatality rate, in other words, the number of people who die after they contract the virus could actually be much lower. Uh, but also that more people are walking around with the virus and could be infectious. Speaker 3: 04:36 Yeah. That, that's the whole point why as you start screening a larger portion of the population with either of the two common tests right now, whether it's you're going to find that the, that that denominator or the population that actually had it is much higher and probably that makes the, the numbers, the percentage of population, at least the percentage of population having fatalities much smaller. Speaker 1: 04:58 Well, I want to focus on this question about accuracy because we saw there was some testing that popped up in Carlsbad that the County shut down because it wasn't certified. Um, are you concerned that the rush to, to offer antibody testing could lead to bad data and actually do more harm than good? Speaker 3: 05:14 Oh, I definitely have concerns about the antibody tests that are available. Um, I looked yesterday, we're now up to 270 antibody tests being developed by commercial manufacturers worldwide. Probably introducing 40 to 50 new tests per week. We carefully selected the tests that we're doing, have done extensive validations on it to make sure it doesn't cross-react. There's always going to be some degree of false positives. It's frequently like on the IgM tests, those are notorious for infectious disease that they come up positive, which we would probably rather have the false positives than the false negatives for those tests. But a lot of the tests that are out there, like the ones that references for shutting them down, those facilities, they are, they are being mass produced. They've not been really tested or validated. There's only one that's actually gone through the F for the point of care type tests, a little cartridge based tests that went through the FDA emergency use authorization process. So unless these tests are fairly thoroughly validated and they're performance verified before they're put out in the community, I would be very cautious. Like I said, we spent a lot of time working on the tests. The, the does the, as I am test, uh, uh, we, we're fairly confident of its performance characteristics relative to these other tests that we've looked at as well. Uh, some of the other tests are just not good tests, Speaker 1: 06:47 but dr McClone, the, the food and drug administration has relaxed its policy in order to let private companies produce tests faster. Do you worry that this is the Fox guarding the chicken coop allowing the companies to certify their own tests? Speaker 3: 07:02 No, they still have to be, they still have to be reviewed, go through a process. They have to do a submission to the FDA before they can get their approval. So there's documentation that the companies have to provide, uh, to the FDA to get that EUA approval. So it's not just a slam dunk. Um, once, once they come back and put that good housekeeping seal of approval, the emergency youth authorization from the FDA, it's been fairly rigorously tested. That's why a lot of these kids, like I say, for the antibiotic tests, there's about 200. I looked yesterday, 270 I think in terms of the PCR tests worldwide, uh, there's probably about 150 of those on the market right now. So there's only a small proportion that actually get through this EUA process with the FDA. Speaker 1: 07:54 And what is your capacity for antibody testing at UC SD? Speaker 3: 07:58 Right now we have the ability to do up to 1200 a day. We have the ability to expand that if we need to. We're waiting to see how quickly the uptake is, both with our testing of our healthcare workers as well as, uh, in the community and the response from individuals in the community. And we've gotten a lot of inquiries in the last week since we started to offer this test. Speaker 1: 08:22 Do you think it's realistic to be aiming for a time when everyone or anyone can take an antibody test? Speaker 3: 08:28 I have my doubts. I know that's the goal. I mean everybody, I know the government will and a lot of, um, healthcare experts are talking about testing the entire population, whether it's with the antibody test where even though the viral RNA test, the PCR tests, I just think that's a very daunting task. Uh, you've seen in the last six to eight weeks how difficult it is to big get testing to everybody in opening up to everybody. There were a lot of great promises about obeying drive throughs and having, you know, the Walmarts and the CVS Walgreens do mass screening efforts. And I think it's been challenging to move that forward. And I think some of the challenges too for places like you CSD and it over time, and I've heard the cross the country about the issues is just getting the supplies to do this testing, whether it's getting the kits. You know, initially we struggled getting even to do the PCR test, uh, sufficient allocations of the kids to do that. That's the reason we brought up six, six different PCR tests that you CSD to cover that, you know, some days we could get supplies from one vendor other times from another vendor. The other thing is collection supplies, the swabs, the viral transport media, exhausting personal protective equipment. That's the reason I've crossed the country. This has been challenging to get more testing out to the public. Speaker 1: 09:58 Do you have any words of warning for policymakers who are relying, who may rely on these test results to decide whether to reopen, uh, parts of the economy? Speaker 3: 10:08 Well, the only words of wisdom I have is that you have to recognize, and I think dr Deborah Berks made a statement about this over the weekend and one of the new shows that I was watching. There has to be a realization that with any type of testing, there is a certain degree of variability, false positives, false negatives there. They're not a hundred percent perfect. And that's what any diagnostic tests, you know, there's biological variability is analytical variability. So are you going to have a 100% solution now? Can you rely upon many of these tests right now to provide some guidance? I do think the ones that are the mainstays that are being used in most laboratories are good and will help inform policymakers to make decisions about re opening the economy when I think you have to be cautious about REO. All of these other kits that are being offered and you know, point of care, home testing kinds of kits. Those are the ones that I think you have to be a little bit more concerned about. Speaker 1: 11:11 So, so individuals taking the test need to be cautious about which tests they're using. I mean, do you see that the, how do you see these tests being most useful to, to let individuals know if they have contracted the virus and have strong antibodies or to help policymakers decide when it's safe to lift a quarantine. Speaker 3: 11:28 And you know, I think the County is struggling to figure out how to deal with the, the, the, uh, antibody tests and capture that information. We've had some conversations there. I think we're still trying to figure out how policy makers and how government agencies are going to use this information, uh, to reopen the economy. But I do think that the, these tests do provide information relative to individual patients who have that potentially been exposed, have had concerns. You know, three months ago I had this fever, vague symptoms and could I have had covet 19 or like I say with healthcare workers who have, who are in the trenches day in and day out, caregivers at skilled nursing facilities, uh, the residents who have been around other individuals who have been infected. I think these tests will, will provide good information as to how to manage those individuals and how to, how caregivers can interact safely and with, uh, patients who have been exposed. Speaker 3: 12:30 I mean, that's the approaches we're taking at UCFD as well. Trying to figure out how best to manage care and making sure that it's safe to go back and reopen and do elective surgeries. And everybody has the appropriate protective equipment depending on, you know, what the status of that that patient is, and if our employees have been exposed, at what point is it safe for them to come back to work? We'll document loan. Thanks so much for taking this time with us. Thank you very much. Appreciate it. I've been speaking with dr Ronald McGlone, director of UC San Diego center for advanced laboratory medicine. Speaker 4: 13:11 [inaudible].