On the Accuracy of COVID-19 Testing: A Physician's Perspective

Aaron Hartman, MD (YouTube, June 10, 2020) describes his direct clinical experience and informal testing comparisons that reveal inconsistent COVID-19 test results across labs and platforms. He reports using multiple commercial labs (Quest, LabCorp, BioReference, Vibrant America) and advanced antibody panels (IgG, IgM, IgA; multi-antigen assays) yet seeing discordant results: reported sensitivity ranges of 38%–98%, PCR-positive patients with negative antibody conversion, and antibody-positive contacts despite some negatives within close clusters. He interprets current testing as insufficiently externally validated, recommends treating COVID-19 as primarily a clinical diagnosis guided by practitioner gestalt and local prevalence, and advises caution when relying on test-and-trace data.
Chapters
You. It's great to be with everybody once again. Today, I'd like to do a summary of some of the experimentation I've been doing in my own clinic. The first thing I want to say is this is my own personal opinion as a medical doctor, but I want to share that with you. And it's based on some of the testing and the sensitivity and specificity of COVID 19 testing. So back in January, when this first came out, we weren't quite sure how to test for the disease. Soon as lab testing was available, I started using it. The labs I was using were Quest, LabCorp, BioReference, and I started using some advanced testing at Vibrant America. And these are all great tests, but I was starting to see some inconsistencies. And as most of y' all know, with the testing, sensitivity runs anywhere from 38% to 98%, which means either it's super accurate or it's worse than a coin toss. And one thing to remind everybody is the testing to date is not officially FDA approved. It's only been approved for short term emergency use, which is what's been happening with the whole pandemic. But there's not been external validation and usually that takes a year or so. What that means is a test done in one company, one office, is validated in other offices across the country. I think this may account for some of the inconsistencies. So I'm going to tell you four different patient stories, starting with my own home, with my own family and my own wife, and kind of walk you through the testing experience I've had. And what drove me to do this was just the inconsistencies I was seeing in my office. Over this whole time, my office has not been closed. I've been seeing patients the whole time. Actually, I've not been off since Christmas, so just been working straight through. And I've had a lot of great clinical experience as an outpatient with this, as well as seeing patients after they've been getting out of the hospital. So, like the first start with my wife, beginning of April, she got short of breath, had some problems breathing for maybe about not quite a week. She'll correct the dates if they're off a little bit. And there's one period in time her shortness of breath was quite severe. I was a little worried about her. She was also having headaches, nausea, maybe for a couple hours one day, lost her sense of smell and taste, weird joint aches, not muscle aches, but joint aches. And these are all minor criteria for COVID 19. Now, right about the same time, we have a young lady who helps my daughter with therapy and things. And that young lady got sick as well. Similar symptoms, headache, nausea, you know, very simple, similar. And one of her friends as well got sick. And the, you know, the whole test and trace thing we talk about, right? You have a case, you test it, then you trace it. Well, the host mom that that young lady lives with actually ended up being antibody positive. So we have the, the initial case and she got sick before everybody else. She was tested with antibody testing that was positive. And then the young lady living with her got ill. The young lady with us got ill. Then my wife got ill. I did not get sick, my kids did not get sick. And so I was kind of excited to see once the testing we had in our office because at that point time it was just kind of hard to get a hold of it. And so I did antibody testing with my wife. It was all negative. I tested myself and it was all negative. I did IgG, IgM and IgA, which is the full spectrum. Most places are only doing igg. So I was again getting a better view of things and it was all negative. So I was waiting for this more advanced test that actually looks at A, M and G, but also looks at four different parts of the virus. It looks at spike protein A, B, it looks at the nuclear material as well as the capsid. So basically it's looking at 12 different things. That test was negative for myself, for my wife, and for the young lady living with us. And so what that just tells me is, wow, the internal validation might be accurate for this test, which had a 98% internal validation. But when you actually deploy it boots on the ground in the active field, there's just a lot of inconsistency that stipulated me to do more. Now I'm a clinical researcher. I have a clinical research company as well. So I kind of do this stuff all the time with all my patients, especially with my functional patients. I'll change labs around as I learn new things. I do a test that someone says is the most amazing test ever. I work with dozens of lab companies, so this kind of stuff is something I do on a regular basis. So second case is actually a friend of mine who travels a lot back and forth to New York City and during this time had also traveled to the east, had been to Singapore, Japan, and he ended up getting sick and his family got sick and they got better. So he came to my office and we did some testing. And again, I did the full spectrum ig, G, A and M with him. And his IGA was the only one positive. Now what that means is he's creating all the antibodies to his respiratory tract and his GI tract, but he wasn't creating the systemic IgG memory ones or IgM, which is kind of interesting because a lot of people have just GI symptoms. You know, my wife had significant GI symptoms for some time and diarrhea, we know those are a part of the minor criteria for COVID 19. So I thought that was kind of interesting. And he had sick and he was a high risk area, so I said he had illness. So to test, this new fancy test that I was referring to, and I'm not trying to say company names when I'm specifics just for legal reasons and I'm not trying to, to stir up controversy. I'm just trying to educate people about testing in general. It's just not super reliable or accurate. So I did the fancy super test on him and it was negative. I repeated the same last test before across all four, expecting to see an IGG positive and they were all negative. So what do you do? Someone who went to all the right places, who got sick, his whole family got sick, so it was fairly infectious. They all got better because they're young and healthy. And again, the numbers support that. If you're everybody, his family's less than 50, his kids are less than 25. They're actually relatively young. So the expectation would be this would be for his family, for his kids, less serious than the flu and for him, like the flu. And it was. Initial testing was positive and it was negative. So even within the same patient, I wasn't seeing reproducibility. So another patient, who, and this is an older couple, so hey, maybe it's more accurate, these people. The wife was sick, came to her office, and she's an older female, multiple health issues. Did a nasal swab on her myself in her office, and the pcr, which is the actual gene testing, came back positive. So I was like, aha, she got sick. I've got that validation. Her husband's with her. I waited several weeks, retested them both, and all their antibodies were negative. So I said, let's give it another couple weeks up to at that point in time, was it five weeks after. Let's do the regular antibody testing, full spectrum IgG A&M and let's do fancy tests on them as well. And a lot of this testing I was. Anyway, I won't go into that, but. So all the antibodies came back negative and this is an older couple who are the high risk people. Wife has multiple health issues, husband has health issues. So even among someone who the PCR was positive, who had the symptoms, the antibiotics weren't converting. And the last story is a brief one as a family where lots of health issues. The daughter was tested, her PCR is positive, and the mom, who I see on a routine basis, multiple health issues like a high risk individual. And she was sick when I saw her, she'd been sick for almost six weeks. Her antibody testing was negative and her nasal swab was negative, though her daughter was positive. So, and I could keep on going on story after story after story that I've done. I've probably done several dozen patients like this. This is not equate for clinical research, but this is part of the reason why we need some kind of external validation on the testing. This is the reason why, you know, these tests are not FDA approved. And so what does that mean for you and I right now? It means that COVID 19 is probably like a lot of viral illnesses, like the flu, for example. We've done flu studies where patients came and we were doing swabs, doing cultures. Data was taking about six months to get back. And this was in a clinical research trial that was NIH sponsored in my research company and was taking six to nine months to get the viral cultures back. Super accurate. And what I was seeing is the patient's clinical symptoms were more accurate than the nasal swab antibody testing in her office. And I was verifying that by viral cultures, which are the most accurate way to do this. So what that means for us today is COVID 19. With the technology we have now, it's a clinical diagnosis. Are you in a high risk area and do you have the symptoms typical for this? And that's gonna be largely determined by you seeing a practitioner who's seen a lot of people, who has a good gestalt, a good feel for what a COVID 19 patient feels like, and knows what's going on in the local environment. Basically, it's everywhere right now anyway. So I would say, hey, it's here. We don't have numbers on Virginia per se, but we do know New York City, 25% of people have had it. So the point of that is, as we go in the summertime, as we're going out there and where people want to get tested to see, you know, if the testing is positive, you've had it, great. If it's negative, can you track it? Can you do, can you do your own testing? And tracing, can you find out, hey, I was sick, I got around this person, they were on this person, that person had a positive test. Aha. Can you do your own testing and tracing? You know, the problem with testing and tracing as a national standard is if the actual testing is inaccurate, you can't really use testing and tracing. Right. So you almost have to kind of do your own thing. And if you have enough people that are getting tested, eventually you get positives and you can track them down. That's how it works in population health, public health. It's just hard to correlate that with individuals. So you have to kind of be your own sleuth. But again, if you're young, if you're less, if you're 25 or less, this is not as bad as the flu. If you're less than 50 without comorbidities, of course, this is like the flu. And if you're older and have comorbidities, this is, this is way worse than the flu. Stay away. Anyway, hopefully that's helpful. This is information that I haven't really, I've been reading about and you see bits and pieces of it, but I want you to share that, my personal experience with everybody and hopefully this will be helpful. I think the take home points are if your test is negative and you feel like you had it, you probably had it. Not super scientific, but that's my clinical expertise and that's based on you seeing a practitioner who's seen a lot of cases, who knows what these things sound like with the patients, how they feel and all that kind of stuff. That's super, super important now more than ever. So anyway, if this was helpful, share with your family and friends. Again, the only way for this information to get around is to be shared and you all have a great, great day, take care and be safe.
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