The FDA Finally Approves a Real At-Home COVID-19 Test

Way late, but better than never.


Good news! An at-home test for the coronavirus is going to be available to consumers. The Food and Drug Administration (FDA) just approved the Ellume at-home diagnostic antigen test for COVID-19. Using a smart phone app, the test detects in about 15 to 20 minutes coronavirus proteins obtained from a nasal swab. The tests will be sold over-the-counter to consumers and cost about $30 per test. The at-home test correctly identified 96 percent of positive samples and 100 percent of negative samples in individuals with symptoms. In people without symptoms, the test correctly identified 91 percent of positive samples and 96 percent of negative samples.

The bad news is that at-home diagnostic testing took way too long to get developed and then approved by the FDA.

Consider that the COVID-19 vaccines that will blunt the course of the coronavirus pandemic toward the beginning of next year were developed as part of the federal government's Operation Warp Speed. Had a parallel strategy of mass testing based on the development of cheap at-home COVID-19 tests been similarly pursued, the pandemic's toll of deaths and hospitalizations would have been much lower. Why?

In a thought experiment, Washington Post columnist Megan McCardle explains how testing could have spared millions of Americans from the disease. Start with 100,000 pre-symptomatic and asymptomatic infected people who will, on average, infect 3 other people. If that 100,000 had taken advantage of a COVID-19 test that detects only 90 percent of infections, that would still catch 90,000 cases. Being responsible individuals who do not want to risk infecting other non-consenting people, the 90,000 with detected infections would then voluntarily isolate themselves. So instead of 300,000 new infections, the 10,000 undetected folks transmit the virus to only 30,000 other people. In the next round of testing, the 3,000 undetected cases transmit to just 9,000 other people. And so forth until the epidemic is essentially crushed.

Ellume aims to produce more than three million tests in January 2021. That's not nearly enough, but it's a start.

NEXT: Mitch McConnell and Several Other GOP Senators Finally Acknowledge Biden's Victory

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  3. will the results of any test be sent to only the user or does the government get to see the results as well. if so I won’t be taking it

    1. It seems to be the user’s option.

      1. for now but I’m sure they have a record that our friendly government will require releasing when they want it

        1. for now but I’m sure eventually our toilets will start reporting back to our friendly government, so I’m just going to hold my shit in for now

          1. But you didn’t. You posted it right there.

    2. Uh… do you really use your real name on this?

      If it didn’t cost $30 I’d test my dog, and a coke, and a papaya, etc.

      Does anyone really believe that these “tests” are as accurate as we are being told?

      Supreme Court of Portugal has ruled that the PCR test (in use throughout the world) is up to 97% unreliable.

  4. So, those folks without a Smart Phone, who either: 1) don’t want one, 2) don’t need one (because they have a life which includes real people, or 3) because they can’t afford one, or don’t feel the need for making phone calls on an $800 phone when a $35 one will work just as well, are shit out of luck. (Note, I have been using computers at home, and at work, for 35 years, and been online since Compuserve. Does anyone else here remember the joy of a 300bps dial-up modem?)

    Luckily, I wasn’t counting on the government to come through on this, or much of anything else, either.

    1. You don’t need a smartphone because you have a life that includes real people? What the fuck does that even mean?

      1. When I am out-and-about, I talk to the people I am with, rather than the one’s who aren’t there. And when I visiting with friends, my flip-phone is turned off. Of course, right now, my visits are online….

      2. Upon exiting a local store I came across a circle of 7 girls. Six of them were looking at their phones. One of them apparently didn’t have a phone and was just kinda standing there (with her “friends”?) looking around and not doing anything.
        Seeing me glance at her she said “Hi” and I returned the greeting.

        To a REAL person.

    2. Well, jeepers, neo-luddites might have to borrow a friend’s phone to take advantage of technology. Or maybe pay a small premium to someone else willing to provide that service. What a shocker. How dare they?

      Of all the possible arguments against the roll-out of this test, that has got to be the stupidest.

      1. I am not arguing against the roll-out. It’s great though I find it hilarious that it took less time to get a vaccine approved. But, seriously, how difficult would it be to make it usable with high-speed internet, an iPad and a good computer, anf wifi? All of these we already have.

    3. Dude….you can feel as holier than though as you want, but 4 out of 5 U.S. adults have a smart phone, so this is still the option that reaches the vast vast majority of people. FYI…you can get a smart phone for less than $100.

      1. I am not “holier than thou,” Hell. I am not holy at all. But sorry, I know some folks who live, literally, on their phone. They have dozens and dozens of “friends.” Nothing wrong with that, but not all of us are that gregarious. Generally, my flip-phone is turned off twenty hours per day.
        Since retiring, I concentrate on traveling and making music. My wife loves traveling, and is also a musician, song-writer, and novelist. We have all the basics — Nice laptop, Klipsch sound system, good amp, wi-fi, and an iPad.

        We have a fairly small circle of friends, and, to put it simply, neither of us can think of a single reason to have a smartphone.

        1. The Ellume site says the sensor is Bluetooth compatible, so it might work with anything that handles that.

      2. I’m one of the four out of five adults with a smart phone.
        I paid $114 for a used iPhone so I could facetime with my grandkids.
        I found that if I was signed in to my phone it would upload everything on my phone to the cloud. Isn’t that great?
        Sometime in October Apple downloaded an “exposure notification” to my phone even though I do NOT have automatic downloads enabled.
        So I don’t sign in to my phone, I don’t have any apps on my phone other than the Apple apps that come with it. I tried to delete all those apps but am unable to delete the “health” app or the “wallet” app.
        My “smart” phone is used to: make and receive phone calls, texts, pictures from family and facetime with my grandkids.
        I guess what I’m getting at here is this: download the app and you’re on a data sheet somewhere. The “test” is positive? Knock, knock, tovarishch.

  5. Quoting anyone at the wapo about anything is ridiculous. Anyway I guess their thought experiments will suddenly change in January. There will be no need for resistance or pithy banners. Because the federal government bureaucracy will be somehow different in their eyes. Just as authoritarian and just as likely to increase spending for no reason.

    Would any COVID test have prevented anything? Who knows. I notice reason shied away from talking real numbers. TFR is still astoundingly low yet the response was extreme. All in service of removing Trump just like every attempt over the last four years. We all know it was Obama who coordinated this which is why he didn’t move away after his term. He may one day be considered the first American emperor or tyrant.

    1. Of course, it’s not practical to test the whole country at once
      Which you would have to do multiple times, since any infected that passed the first round would be mixed in with the uninfected.

      1. yeah, it’s the Testing Saves Us All Fallacy. It only works if everyone gets tested every day before they go out, the results are immediate, and the accuracy is 100%.

        1. And if people who test positive actually isolate themselves.

        2. And even then, testing negative doesn’t mean that you’ll still be negative 30 minutes from now.

  6. It’s an ap that says you have covid and adds you to the list of known positives, then it links you to web md where it says you also have cancer

    1. But then says you have to wait until the pandemic is over before you can start chemo.

      1. And then says you are at a high risk for suicide.

  7. they’re tossing around opinions on tests at my office and one guy says “wait 8 days from exposure to test or it won’t do you any good. exposure day is Day Zero” but the guy who “got coronavirus” in my office was here all 5 days last week. also every person on Earth could be an Asymptomatic Angel of Death.

    howdafuq does anyone know Day Zero?

  8. Start with 100,000 pre-symptomatic and asymptomatic infected people who will, on average, infect 3 other people. If that 100,000 had taken advantage of a COVID-19 test that detects only 90 percent of infections, that would still catch 90,000 cases. Being responsible individuals who do not want to risk infecting other non-consenting people, the 90,000 with detected infections would then voluntarily isolate themselves.

    This bullshit thought experiment assumes facts not in evidence. Whom are the average 3 people that the carrier infects? Coworkers? Family members? Grocery store clerks? Delivery people? If it’s the latter, what are these positive testees supposed to do? Starve for two weeks until they’re asymptomatic?

    With only 10K or 100K people infected, how is the test to be validated to 90+% sensitivity/specificity before others are infected?

    Here’s a thought experiment, detect and execute patient zero. Problem solved. If we’ve had nuclear weapons in the Civil War, the North could’ve won without killing 750K casualties.

    Thought experiment = ignore reality.

    1. killing 750K casualties

      *causing* 750K casualties.

  9. “If that 100,000 had taken advantage of a COVID-19 test that detects only 90 percent of infections, that would still catch 90,000 cases. Being responsible individuals who do not want to risk infecting other non-consenting people, the 90,000 with detected infections would then voluntarily isolate themselves. ”

    LOL. That’s not how people work.

    What happens is that healthy people take the test to prove they are healthy, so they can continue to not wear masks. But they don’t take it every day. They take it 3 times in March, don’t have it, and say “fuck it” and never take it again.

    Then when they get sick, they hide their symptoms and don’t take the test because they don’t want their kids sent home from school.

    How often do you expect someone making $10/hr to take a $30 test, even if they do have a smart phone?

  10. Way late, but better than never.

    Not by much. This’ll be over by April.

  11. I’ve heard there’s a smartphone app that just listens to your cough and is 95% accurate.

  12. There are physicians selling fingerstick at home antibody test kits over Youtube, for Pete’s sake. Where has Bailey the Science guy been?

    Thats been happening for a while. Fifty bucks a pop, minimum order of 20 tests.

    1. You’re clear on the difference between SARS-CoV-2 antibody tests and active SARS-CoV-2 virus tests, right? You know those are different things, right?

  13. Is there a subscription option so I can get the test continuously updated for each new virus as China releases them?

    1. Probably available from Alibaba. 😉

    2. Now, now. By this time, everyone knows that the Chinese did not introduce the virus — Randy Marsh brought it here.

      1. Wow, republicans are so in denial now that they literally believe a cartoon character is spreading Covid-19. Stop, take a moment and ask yourself, how in the living hell would a cartoon character spread a freaking virus?
        Yes the virus technically came from China (oooh bad word around here, I know) but it’s not China’s fault people died. Think about that for a moment (like actually think if that’s even possible with you people) and get back to me.

        1. They didn’t want us to die. They just wanted us to get caught up on Netflix shows.

        2. But it’s peoples fault when they don’t wear a mask? The duplicity is disgusting. Enlightened like a 20 watt bulb.

          1. Enlightened like a 20 watt bulb.

            My IQ is certified 159, friend. I’m guessing you’re a bit of a dim bulb yourself considering we weren’t even talking about masks. In the future, try to keep up, thanks.

            1. Pretty sure you misplaced the decimal in that number.

        3. He fucked a pangolin.

          Read the fucking news.

    3. Can we stop blaming China for every bad thing that happens in the world? Thanks.

      1. I’m sure they aren’t responsible for EVERYTHING bad. Biden’s dementia, for example.

        1. Biden does not have dimentia, ergo this statement makes little to no sense.

  14. Why does it need an app? Is that feature purely for surveillance purposes?

  15. It appears that many communities, counties and states are close to achieving herd immunity from covid (without any vaccines).

    After rapidly increasing in the past 3 – 5 months, the rate of new covid cases has peaked and is now declining in more than a dozen states in the midwest, prairies and Rocky Mountains.

    Previously published studies have found that 3 – 10 times more Americans have been infected with covid (than have tested positive for covid), and herd immunity will likely be attained after/when 70% of people have been infected (and/or vaccinated).

    States with the highest rate of covid cases (i.e. tested positive) are
    ND – 11.6%
    SD – 10.3%
    IA – 8.2%
    WI – 8.1%
    NE – 7.7%
    UT – 7.4%
    MT – 6.9%
    WY – 6.9%
    TN – 6.8%
    MN – 6.8%
    IL – 6.8%
    KS – 6.7%

    Twenty one states have surpassed a 6% covid case rate, and the
    US covid case rate is now up to 5.2%.

    And according to data at
    counties in the US with the highest covid case rates are:
    Crowley, CO – 24.8%
    Norton, KS – 21.0%
    Bon Homme, SD – 20.4%
    Chattahoochee, GA – 20.0%
    Lincoln, AR – 19.9%
    Dewey, SD – 19.8%
    Buffalo, SD – 19.7%
    Trousdale, TN – 18.3%

    Herd immunity will likely be attained in hundreds of counties and dozens of states just as or before vaccines will be made available to the public.

    So why won’t anyone write about this forthcoming victory for public health? The reason is that Big Pharma wants to make lots of money from their vaccines.

    1. Additionally, 7.0% of people in Rhode Island have tested positive for covid.

      If five times more Americans have been infected with covid (than have tested positive for covid), thousands of communities, hundreds of counties, and ten states are at least halfway to achieving herd immunity, and 26% of all Americans have already been infected.

      1. Ah I misread what you were saying. That’s total people in the state who have tested positive.

  16. But we still can’t get an IgG antibody test, which is the more important one.

    Simple as testing your glucose and only costs a couple bucks.

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  18. At $30, the Ellume test won’t be used every workday morning, and it’s the test that’s FDA approved. At $5, the Abbot BinoxNOW test would be used every workday morning, but it’s FDA restricted. The story isn’t that the FDA is slow but has finally approved a test, it’s that the FDA has made medically-indefensible decisions on these tests, and these decisions are killing people.

    1. Yep the real story is that the FDA wouldn’t approve a rapid result test for home use until it was linked to a smartphone to report the infection to the CDC.

      The FDA feels that you do not have the right to take a COVID test without the CDC being able to gather statistics. They would rather you infect others or die rather than miss out on collecting infection stats.

  19. The test is still too expensive. Are people going to spend half a day’s salary to see if they can go to work? No.

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