Coronavirus

The FDA Has Been Way Too Slow on At-Home COVID-19 Testing

With antigen testing, the U.S. could have been well on its way toward crushing the pandemic by now.

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COVID-19 diagnostic testing has been greatly scaled up from a few thousand tests per week back in early March to 2 million tests per week in late July. But the summer upsurge in COVID-19 diagnoses, hospitalizations, and deaths in the U.S. highlights the fact that that amount of testing is not providing both individual Americans and health care professionals with enough information to curb the pandemic's spread.

"In many states, it now takes 10-15 days to get test results—rendering these tests useless as a tool to prevent transmission and bring the pandemic under control," notes Harvard medical professor Ashish Jha in Time. A big part of the problem is that most asymptomatic, pre-symptomatic, and mildly afflicted people don't know that they are infected as they spread the virus to others while working, shopping, and gathering in enclosed spaces like bars and restaurants. Researchers believe that people are at their most infectious about two days before they experience any symptoms of the disease.

Making cheap rapid tests available for use at workplaces, schools, and at-home could solve this information deficit problem. "The way forward is not a perfect test, but one offering rapid results," Jha argues.

Last week, the Food and Drug Administration (FDA) issued its template for approving tests that "can be performed entirely at home or in other settings besides a lab, such as offices or schools, and that could be available without a prescription." It's about time. "We hope that with the innovation we've seen in test development, we could see tests that you could buy at a drug store, swab your nose or collect saliva, run the test, and receive results within minutes at home, once these tests become available," said FDA commissioner Stephen Hahn. "These types of tests will be a game-changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening."

According to George Mason University economist Alex Tabarrok, it's way past time for the FDA to take this step. "A cautious, risk-averse FDA with an exponentially growing virus — that is a recipe for disaster, and that is exactly what has happened," Tabarrok said to the Washington Examiner. "The FDA, as usual, following their standard operating procedure, has been very slow, and I think that has impeded testing right from day one."

The good news is that there are a number of companies that are working on and could soon deploy rapid at-home COVID-19 diagnostic tests based on detecting viral antigens. Antigen tests work by detecting the presence of coronavirus proteins using specific antibodies embedded on a test strip coated with nasal swab samples or saliva.

The Cambridge, Massachusetts, biotechnology startup E25Bio is already seeking FDA approval to launch by September 1st its direct antigen rapid tests (DART) for COVID-19. According to a press release, it is designed as a cheap, paper-based test similar to a pregnancy test that can deliver a visual readout of COVID-19 results in 15 minutes or less. The company says that its manufacturers will be able to produce millions of tests per week.

I reported in July that researchers at the Massachusetts Institute of Technology (MIT) and the technology conglomerate 3M announced that they are collaborating to roll out a highly accurate antigen test that delivers results within 10 minutes, also via a paper-based device. The MIT press release notes that "the Covid-19 test would not need to be administered in a medical setting." This suggests that the tests could eventually be sold directly to consumers for at-home diagnoses. Once the test is sufficiently validated, 3M plans "to produce millions of the affordable, accurate tests each day." The researchers think this will be possible by the late summer or early fall.

What at-home antigen tests lack in accuracy compared to lab tests they more than make up for in frequency of testing. Accuracy of diagnosis would be increased by repeated testing that would also identify the higher viral loads during an individual's most infectious period. For example, one simulation published in JAMA Network Open looked at the impact of antigen testing every two days on a 5,000-student college campus. Their model suggested that such screening could limit an outbreak beginning with 10 students to just 28 infections by the end of the semester.

The pandemic is occurring in an open-access health commons in which individuals cannot take full responsibility for spreading disease. Making cheap COVID-19 antigen tests widely available sooner rather than later would provide Americans the information they need to take such responsibility.

Given that in its response to the pandemic that federal government has already borrowed $3 trillion and appears set to borrow trillions more, as I argued earlier, the cost of $15.6 billion to provide 300 million Americans with at-home test kits costing $1 each for weekly use would be a real bargain. Knowing that their fellow citizens are taking responsibility for their microbes would give Americans the confidence to venture out of lockdown and return to work, travel, school, and the pleasures of bars, restaurants, concerts, sporting events, and movies.

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  1. Oh fuck off.

    1. ^this gal gets it

      1. I am sure it’s something you are used to hearing from women.

        1. And the rest of us are sure you’re a eunuch who begs leftists for approval, but is nonetheless despised

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        2. You know what I hear from women?

          NOTHING!

  2. A big part of the problem is that most asymptomatic, pre-symptomatic, and mildly afflicted people don’t know that they are infected as they spread the virus to others while working, shopping, and gathering in enclosed spaces like bars and restaurants. Researchers believe that people are at their most infectious about two days before they experience any symptoms of the disease.

    So, if someone is asymptomatic can we compel them to take a test and *more importantly* disclose the results? Doesn’t that violate their 1A rights and presume their guilt up front?

    Not to take the side of the government (the opposite, actually) What if “someone” is a sitting Congressman, Justice, or even President? Can a diagnostic test also be a purity test?

    1. We could operate under the assumption – which, granted, is more valid outside of the Reason comment section than it is within it – that most people don’t really want to make others sick and would willingly take a test on their own to determine if they are healthy enough to be in public. Especially people who have jobs which demand that they interact with a lot of people, such as teachers or retail staff. Before we start leaping to the whole “well what about the compulsion” angle, let’s start by trusting that people will tend to do the right thing without the need for compulsion.

      1. Jeff agreed I don’t want to make others sick but as mad states the guilty until proven innocent basically makes me want to say a big f you to the folks that’d push for the compulsion. I’m going to stay home if I don’t feel well but I’m not going to test if I’m asymptomatic. I do have a question on the asymptomatic part do I need to test every hour or every time I come into contact with someone to be sure I’m not spreading?

        1. Well then with all due respect, I think you ought to be an adult about it. If the authoritarians say “love your mother”, then don’t give your mom the finger just to spite the authoritarians. Of course the authoritarian minded would love to mandate testing and force contact tracing apps onto everyone’s smart phones. The way to head off the authoritarian bullshit is for people to act like mature responsible adults instead.

          And I have no idea about the frequency of testing thing. Maybe Ron Bailey would know.

          1. With all due respect, which isn’t going to move the meter much, I think you ought to fuck off.

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          2. So beat the authoritarians to the punch, and do their work for them? You know, Chemjeff, there seems to be something here that you’re not quite grasping.

            1. “So do the right thing, even if no one forces me to? Gay!”

              You aren’t quite grasping how analogies work. Or conversations.

              1. Why did you switch socks?

            2. Look, if an idea is a good idea, it’s a good idea whether authoritarians want to mandate it or not.

              It’s a good idea to wear a seat belt while driving, that was true before it was mandated, and that is true now after it is mandated.

              It’s a good idea to brush your teeth before going to bed, it’s a good idea even though it’s not mandated, and if it were ever mandated someday (shudder), it would still be a good idea to brush your teeth before going to bed.

              I think wearing a mask is a good idea, and I urge others to do so as well, voluntarily, via persuasion not mandates. That is true regardless of whether it is mandated or not.

              1. Except it’s not a good idea, as others have pointed out repeatedly.
                I’ve stated directly why I think it’s a very bad idea.
                But you ignore these things, and pretend that your fantasy is objective reality.
                This is psychotic

              2. Regarding test mandates, it’s a legitimate conflict between giving the government enough power to protect us from unknowing asymptomatic individuals, disrespectful others who know they might have it, and those who knowingly have it , but go about interacting with others anyway (George Floyd interestingly fits in this category as we recently learned, which still doesn’t make what Chauvin did right). Certainly a topic for libertarian debate, but this is outside the scope of the article. As a long time libertarian, I’m inclined to give government the power to force testing, though I have mixed feelings on forced vaccination.

                “… as I argued earlier, the cost of $15.6 billion to provide 300 million Americans with at-home test kits costing $1 each for weekly use would be a real bargain.”

                I wish Mr. Bailey was a bit more clear here. A cost of $15.6 billion for 300 million tests, is $52/test, not $1/test. What is the money for? Test development, subsidized test costs, or $51 to create the program and administer the tests? Otherwise I agree with him: the only really good way to deal with this crisis, is frequent and inexpensive testing.

      2. let’s start by trusting that people will tend to do the right thing without the need for compulsion.
        How many cities are now setting fines for not wearing masks, Pollyanna?

        1. How long after people started pointedly ignoring and protesting precautions did it take them to do that?

          1. “Baby, please don’t make me hit you.”

            1. “It’s my fault for wearing that dress.”

      3. Before we start leaping to the whole “well what about the compulsion” angle, let’s start by trusting that people will tend to do the right thing without the need for compulsion.

        Do you trust me to do the right thing? If I tell you to do the right thing, will you do it?

        1. For the most part, yes I’ll trust you to do the right thing, broadly speaking. If you can persuade me that your idea of “the right thing” is the right thing, then I’ll be willing to go along.

          Again I don’t think most people really want to make people sick.

          1. And yet with the mask question you are skipping right past the persuasion and the 40 years of studies showing masks do not mitigate risks from viruses.

            So since you aren’t persuasive how does your logic proceed from here.

            1. https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-mask/art-20485449

              Can face masks help slow the spread of the coronavirus (SARS-CoV-2) that causes COVID-19? Yes, face masks combined with other preventive measures, such as frequent hand-washing and social distancing, help slow the spread of the virus.

              Are they wrong? Why are they wrong, Jesse?

              1. This is like saying “This pill, along with diet and exercise, helps you lose weight!”

                If they could say that masks alone slowed the spread, they would. But they don’t, they hide it in the middle of a weasel statement.

            2. Here’s another one, Jesse:

              https://www.ucsf.edu/news/2020/06/417906/still-confused-about-masks-heres-science-behind-how-face-masks-prevent

              There’s laboratory studies which show that masks reduce the transmission of droplets, and then there’s epidemiological evidence that masks reduce the spread of COVID.

              1. Why do masks work for covid19, but no other viruses?

      4. >>which, granted, is more valid outside of the Reason comment section than it is within it

        you speak to the world?

        1. Depends if it’s happy hour or not.

      5. We should actually operate on the assumption that life is a lifetime of interactions with bacteria and viruses that induce a certain risk to life that we have lived with for millennia. Over reactions like we have had to Covid have occurred in other instances of our lives, such as the peanut allergy over reaction. Why not trust evolution that has developed a good mechanism to fight off constantly evolving disease instead of locking everything down in a panic.

        Your immune system needs to work to be efficient. Peanut allergy policies caused a huge increase in actual deadly allergies. Over cleaning has lead to an increase in allergies as well. Our bodies have been developed to have an immune system. Covid in the grand scheme of things is a small risk of life. Those under 50 have the same risk of death as driving to work daily. Yet you ask others to change their lives to protect you.

        Oh I know, you can’t stop eating so you want others to change their lives to lower your risk instead of you eating less.

        1. I certainly broadly agree with your comments. I really wonder if people staying isolated and apart is going to lead to weaker immune systems (along with, and for similar reasons to, over cleaning).

        2. First: What about individuals who have compromised immune systems or are otherwise at risk? Should there be any public health measures devoted to them? Some of these individuals do not have the luxury of staying home forever. Is it really fair to ask them to risk death just to go shopping?

          Second: What if the disease is much worse than coronavirus? Like, heaven forbid, a more contagious version of Ebola? Should we just “let the immune system work” then? If not, then what is the line that should be drawn, and how do we know when that line should be drawn?

          Third: Is it really too much to ask people to be basically courteous to others? Do you hold open doors for strangers from time to time? That isn’t mandated, yet I’m sure you do it, because even you act like a decent human being occasionally. What is wrong with requesting that people be courteous?

          1. On your first point, No. If you have a compromised immune system, then it is your responsibility to take care of yourself just as it is mine to take care of myself. I should not have to lock myself away because you have issues just as I would not expect you to do the same. If by your own volition you decide to do that it is your privilege to do so. Not to mention the large number of alternative ways they can get their groceries delivered to them, local churches and other volunteer organizations are doing it right now. Most grocery chains are also helping out those who need extra care…and without having to be forced to by fiat. I understand the urge, the vicarious pleasure some get from using the government to force people to do what they want them to do like the ridiculous no peanut rules in place because someone may or may not come close to you who has an allergy instead of the people who have those allergies just taking precautions and or asking for assistance. Just don’t ask me to agree with them.

            On your second point, firstly Ebola cannot get much more contagious than it is already and if there was a break out of it here the infected would not be able to go to the grocery store not to mention they would be pretty easy to spot…so swing and miss there. However, you would not need to force people into lockdown if there was an Ebola (I assume Ebola/Zaire or Ebola/Sudan and not Ebola/Reston as it was not deadly to humans and was already in the US) outbreak, people would do it voluntarily as it has a 80+% fatality rate as opposed to a .4% (on the high end) fatality rate.
            On your third point, No it is not too much to ask and I readily put my mask on when entering a building but they are not asking us they are mandating you do it and if you don’t they will be sending nice gentleman with sticks and guns around to force you to and take a little of your money from you to boot. And that is the sticking point for most, if they had recommended and asked most would oblige but they mandated by fiat.

      6. I’d only take a COVID test if you could guarantee me that there would be no compulsion used against me. There was just a story in the news not long ago about that… a woman “asked” to sign a paper saying she wouldn’t even use an ambulance without getting permission from the department of health (not open 24-7 btw) first, and when she refused, they placed her and her husband under actual house arrest with no charge, no trial, no due process at all.

        No way in _hell_ would I take a COVID test.

        The idea that people without symptoms are a major source of spread is still a very sketchy idea, and as Carl Sagan said, “Extraordinary claims require extraordinary proof.” Show me the extraordinary proof that this is happening. All I see is “could” and “might” and “estimate.” That’s not proof… that’s guesses.

  3. Yes, please. More rapid testing options ought to be available for everyone.

    1. Yes, please. More rapid testing options ought to be available for forced on everyone.

      1. If you say so. I don’t think they ought to be forced on people though.

    2. The only reason we don’t have things which don’t exist is those evil corparashuns!

      1. If you say so. I think there are also a lot of technical hurdles, as well as government regulations, when it comes to things like at-home COVID tests.

  4. Such tests obviously will not have 100% sensitivity (i.e., 100% of those with the condition will test “positive”) or 100% specificity (i.e., 100% of those without the condition will test “negative”).

    It is already hard to get people to wear masks in some areas. That would likely get worse once such tests are widely available. Those that tested ‘negative’, perhaps falsely so, on their daily home test would be more likely not to wear a mask (“Why? I’m healthy and just tested clean!”) and those that were false negatives would therefore tend to spread more of the virus around. At some point it could become assumed in some communities that if you are wearing a mask you must be infected and tested so (why else would you wear a mask?) which would discourage mask wearing even by the cautious.

    Those who get positive results, even false negatives, will begin to overwhelm doctors and ERs in a panic when many of them would have shown few if any symptoms. Hopefully, though, these people would quarantine once a doctor said to.

    If these tests also included indication of past infection by SARS-CoV-2, that could lead to false confidence when receiving a positive test result and cause many to stop bothering with handwashing, rubbing eyes, avoiding close contact with others, etc. First, we don’t know if, to what extent, and for how long, immunity is inferred by prior infection. Second, some of those “past infection” test results will probably be false – so some people who have no protection from the disease will think they do and increase their reckless behavior.

    It might be a good idea and investment to provide such tests, but without knowing the sensitivity and specificity, it’s hard to tell.

  5. as I argued earlier, the cost of $15.6 billion to provide 300 million Americans with at-home test kits costing $1 each for weekly use would be a real bargain.

    Sure, all we have to do is wish we had a test available for $1. That worked out for Theranos.

  6. Fantasy land dreams of everyone testing, getting accurate results at low cost, and “doing the right thing”.

  7. I thought Ron was supposed to be the science writer? Is it just me, or is this an accumulation of factoids and opinions glommed tpgether to point a finger at the FDA, which at this point, isnt in the way or holding up anything. The FDA doesnt make anything…they just define standards and approve tests, which they already published. Now its just waiting on the technology. If and when the fda holds up a promising technology for testing, fine. But that aint now.

    And love how an economist is quoted, Who gives a fart? Maybe have a pediatrician comment on the next market bubble, eh?

    1. Several companies had at-home tests ready to roll out in April. The FDA put the kibosh on them.

      1. That seems highly unlikely.

        1. It is. Those kits had fairly high false positive rates. Making the tests essentially useless.

    2. Apparently the point is to argue we can afford a test which doesn’t exist, and to blame someone for the fact that it doesn’t.

    3. “to point a finger at the FDA, which at this point, isnt in the way or holding up anything. ”

      You have got to be fucking kidding me.

      The FDA is the org that makes drugs prescription only. They not only prevent *us* from choosing to take HCQ is we’re so inclined, they’re busy propagandizing against it to keep the medical mafia from allowing us to use it.

      It’s funny. Reason will campaign for our right to get high on pot and heroin, but not for our right to purchase the medicine and medical care we want w/o government authorization.

      It’s all My Body My Choice when it comes to getting high or aborting a pregnancy, but not when it comes to healing ourselves and cutting into the rent-seeking medical mafia’s profits.

      It’s almost like all their “libertarianism” is simply shilling for corporate profits.

      1. I agree, two reasons to take a vacation in Mexico, to enjoy the warm beaches and to purchase a load of antibiotics. That way you don’t have to go to the doctor every time you get a sore throat. I have traveled all around the world and this is the only one I have been to where you can’t get them without a prescription.

  8. >> crushing the pandemic

    no.

  9. Voluntary at-home testing would have been good to have, if the FDA had gotten out of the way back in April.

    But the sort of people who order at-home medical tests aren’t the sort of people who hang out with friends at parties or in bars, or take to the streets for mass protest super-spreader events.

    1. Would like to know where this claim of at home tests in april is coming from. Since that has been a big technological hirdle for pretty much the entire world.

      Were they perhaps ‘claims’ of at home tests that were shown to be pipedreams geared to boost a penny stock?

  10. I don’t think it would matter given that the youth decided to protest and violate all of Fauci’s recommendations.

    So anyway 0.5% will die. Good luck. Who fucking cares. Go back to work assholes.

    1. So anyway 0.5% will die.

      *This year*. Know what happened to the flu that killed 100k+ people in 1957? Or the one in ’68?

      Did we just bottle them up so they couldn’t hurt anyone in 1958, ’59, and ’60 or ’69, ’70, and ’71? Or did they just continue right along killing 100k right up until we didn’t developed a vaccine for them?

      1. By the summer of 1919, the flu pandemic came to an end, as those that were infected either died or developed immunity.

        Almost 90 years later, in 2008, researchers announced they’d discovered what made the 1918 flu so deadly: A group of three genes enabled the virus to weaken a victim’s bronchial tubes and lungs and clear the way for bacterial pneumonia.

        Since 1918, there have been several other influenza pandemics, although none as deadly. A flu pandemic from 1957 to 1958 killed around 2 million people worldwide, including some 70,000 people in the United States, and a pandemic from 1968 to 1969 killed approximately 1 million people, including some 34,000 Americans.

        More than 12,000 Americans perished during the H1N1 (or “swine flu”) pandemic that occurred from 2009 to 2010.

        1. Almost 90 years later, in 2008, researchers announced they’d discovered what made the 1918 flu so deadly: A group of three genes enabled the virus to weaken a victim’s bronchial tubes and lungs and clear the way for bacterial pneumonia.

          Did they ever find out why the Spanish flu hit young people so hard?

          1. Exposure to an influenza virus at a young age increases resistance to a subsequent infection with the same or a similar virus. On the flip side, a person who is a child around the time of a pandemic may not be resistant to other, dissimilar viruses. Flu viruses fall into groups that are related evolutionarily. The virus that circulated when Adolfo was a baby was likely in what is called “Group 2,” whereas the 1918 virus was in “Group 1.” Adolfo would therefore not be expected to have a good ability to respond to this “Group 1” virus. In fact, exposure to the “Group 2” virus as a young child may have resulted in a dysfunctional response to the “Group 1” virus in 1918, exacerbating his condition.

            Support for this hypothesis was seen with the emergence of the Hong Kong flu virus in 1968. It was in “Group 2” and had severe effects on people who had been children around the time of the 1918 “Group 1” flu.

            So the lesson is: Hiding from the virus is a bad idea.

            1. The study showed that an outbreak in the late 1800’s was most likely the culprit. It had exposed them to a Group 2 virus so when they were infected with the 1918 strain the body reacted aggressively to attack the virus. It was fatal to those with the strongest immune systems because the response was so overwhelming, a symptom called a Cytokine storm. There’s a great book on this, The Great Influenza, it came out before the study that pin pointed the cause of the high mortality but it is a good read. It has two parts, it talks about the pandemic and the fight to stop it, but it also shows a medical system in transition from the bleeding and leaching to antiseptics and vaccinations. It is amazing that before we the advent of electron microscopes and the ability to actually see viruses they knew they existed.

            2. What you just described is 100 years of viral knowledge that was flushed down the toilet in favor of a science fair paper written by a 14 year old.

  11. “…”The way forward is not a perfect test, but one offering rapid results,” Jha argues…”

    No it isn’t.
    Tests offering results akin to a coin-flip, and likely to be wrong a week later (since we are informed immunity is not conferred by infection) are worse than worthless.
    It’s like getting directions from the guy on the corner at the stoplight; you now think you know where to go. You were better off admitting your ignorance.

  12. COVID-19 would be defeated by now if we would not have locked down the people who were not old/sickly and let herd immunity actually do what it has done since the dawn of time. It has kept us alive and allowed us to get to a point where the earth was over populated and made us wonder if we could feed the planet. Both federal and state governments became to controlling and have inhibited herd immunity. Too, much government once again. It should give us good information and allow us to make decisions and not be draconian as it has been. Bad policy has kept the virus from being defeated although it is losing as we speak. The media is not reporting the facts, only misrepresenting statistics.

  13. The FDA and the CDC should both be defunded and dismantled. Newer agencies with a much narrower scope and mission should replace them. This pandemic has illustrated that neither agency is up to the task and have proved that both the FDA and the CDC have actually caused more harm than good.

    The FDA should only be testing drugs for safety, not for efficacy which was their original mandate. Private medical institutions and pharmaceutical companies can fund and conduct studies to prove efficacy. The result would be huge time savings from lab to patient.

    Centralizing everything under a burdensome bureaucracy has a huge downside which is a single point of failure. We know that both the FDA and CDC have failed and we have scrambled to recover.

    The headway that has been made had been accomplished by rescinding many of the burdensome regulations. Let’s remove these regulations permanently. I believe that both the FDA and CDC are beyond reformation and we need to start over with new streamlined agencies that are limited by law from expanding their scope.

    1. They don’t exist.

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  15. Perhaps the test could indicate whether I was exposed to COVID and whether I am pregnant too. Wait…forgetaboutit, I am a guy.

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