22 ms·

FDA authorizes rapid, at-home coronavirus test

347 points by KoftaBob 6y ago

joshstrange 6y ago
Can we get a better link/source? This Axios "article" doesn't have any of the details that the title of this post has (specifically ~$30 or 15min). Maybe it's just the confusing layout but the "article" under the one linked [0] does appear to have this info in it so maybe the link should be changed to that? I really hate it when news sites do this multi-article-page nonsense. It makes it so hard to link directly to information. [0] https://www.axios.com/fda-emergency-use-ellume-coronavirus-test-60152fdb-b691-4954-8068-b4d350c57ee2.html https://www.axios.com/fda-emergency-use-ellume-coronavirus-t...
- monkpit 6y ago
  It’s not ~$30, it’s -$30... They pay you! /s
  - joshstrange 6y ago
    Hahaha, and here I thought my eyes were just playing tricks on me and I didn't look closer. I even saw the "-" and initially thought the same thing but then I, wrongly, assumed it was just the font and it was a subtle "~".
  - jancsika 6y ago
    You have to break through a wall so you can approach the checkout counter from the wrong direction. But once you do it the cashier will give you $30 in "change" without you ever having paid! Only problem is when you leave you end up back in the entrance to the store, until you die.
    - selimthegrim 6y ago
      SCP or Kool-Aid Man, I have to squint to tell which
KoftaBob 6y ago
Apologies, here's a more comprehensive source with the $30 cost mentioned: https://www.nbcnews.com/health/health-news/fda-authorizes-first-home-over-counter-covid-test-n1251287 https://www.nbcnews.com/health/health-news/fda-authorizes-fi...
ortusdux 6y ago
The test is made by Ellume. Here is their press release about the approval: https://www.ellumehealth.com/2020/12/15/fda-authorizes-ellume-covid-19-home-test-as-first-over-the-counter-fully-at-home-diagnostic-test/ https://www.ellumehealth.com/2020/12/15/fda-authorizes-ellum... Here is the product page: https://www.ellumehealth.com/products/consumer-products/covid-home-test https://www.ellumehealth.com/products/consumer-products/covi... I cannot find any pricing info, but I doubt that a Bluetooth enabled at-home virus test is $30. I would image that the consumables for one test would be $30/ea.
- bydo 6y ago
  The Washington Post says "about $30": https://www.washingtonpost.com/health/2020/12/15/covid-home-rapid-test/ https://www.washingtonpost.com/health/2020/12/15/covid-home-...
  - ortusdux 6y ago
    Interesting. The NYT says: "Each kit, which tests a single swab sample, is expected to cost about $30 or less, said Bella Zabinofsky, a spokeswoman for the company." So it sounds like a one time use kit. https://www.nytimes.com/2020/12/15/health/rapid-covid-test-ellume.html https://www.nytimes.com/2020/12/15/health/rapid-covid-test-e...
    - Balgair 6y ago
      $30 is ... a fair bit? I may be off base here, but that seems like it's a bit too expensive for a lot of people. If you could price it at a subway ride or a slice of pizza ($3 ?) that would be better. But I doubt they are trying to churn a profit here and that it costs as much because, well, it's expensive biochem.
- adrian_b 6y ago
  In Europe, I did such a fast test with results in 10 minutes, with visual reading, like in pregnancy tests, so no Bluetooth. The cost was less than $15, so if the Ellume test is double, then $15 would be just for the Bluetooth transceiver plus maybe a surcharge for the US market, as here all medical services are more expensive.
brandur 6y ago
For anyone else wondering about the benefits/downsides of the various tests (why do one that takes multiple days when you can do that takes 15 minutes?), the FDA has a pretty good page on this subject: https://www.fda.gov/consumers/consumer-updates/coronavirus-disease-2019-testing-basics https://www.fda.gov/consumers/consumer-updates/coronavirus-d... The tests that swab your nose or throat and take multiple days are called "molecular" tests and are considered highly accurate. They use controlled heating and cooling cycles to convert the virus' RNA to DNA, which can be detected by specialized lab technique after binding probes to it. Tests like this 15 min one are called "antigen" tests and are still accurate/helpful, but are known to produce more false negatives and false positives compared to molecular.
- pmoriarty 6y ago
  "Tests like this 15 min one are called "antigen" tests and are still accurate/helpful, but are known to produce more false negatives and false positives compared to molecular." On a large scale, the wrong results from such tests don't matter if you test people often enough (say, every day). If you get a wrong result one day, it'll probably be corrected in the next day or two with more tests. If there was a massive government initiative to manufacture such tests and subsidize them so that everyone got them every day this pandemic could be effectively halted in very short order, even without a vaccine. Almost 6 months ago, the This Week in Virology podcast went in to great detail about this plan, starting at about 6'20" in to episode 640: https://www.microbe.tv/twiv/twiv-640/ https://www.microbe.tv/twiv/twiv-640/ There was also at least one NYT article about it, and it was discussed on HN here: https://news.ycombinator.com/item?id=23878954 https://news.ycombinator.com/item?id=23878954 Unsurprisingly the government did not do this, and we had six more months of deaths instead.
  - Analemma_ 6y ago
    > On a large scale, the wrong results from such tests don't matter if you test people often enough (say, every day). But is anyone going to be getting the test every day? Particularly when it apparently costs $30. At that price, once is fine but nobody is going to be doing it over and over; they'll just treat whatever result they get (positive or negative) as binding.
ttul 6y ago
96% sensitivity rate for people with symptoms. 91% sensitivity rate without symptoms. Given the ramp of virus replication between the time that one is asymptomatic and when one is infectious (ie hours), this sensitivity rate is excellent for an at-home test. Imagine if such a test had been available to everyone nine months ago. The pandemic could have been effectively ended.
- noneeeed 6y ago
  Interesting, this seems much better than the "lateral-flow" tests that we've started using in the UK for mass community testing. Apparantly those are only detecting about 50% of positive cases (not sure what the symptomatic/asymptomatic breakdown is). 90-95% sensitivity will be a real game changer.
  - novok 6y ago
    There is a math that you have to apply with the amount infected. Like a test that is %99 accurate for a disease that only happens %0.001 of the time will have high false negative or positive rate, which is somewhat unexpected result. More detail: https://www.lesswrong.com/posts/XTXWPQSEgoMkAupKt/an-intuitive-explanation-of-bayes-s-theorem https://www.lesswrong.com/posts/XTXWPQSEgoMkAupKt/an-intuiti...
- mrlala 6y ago
  Eh not for $30 a pop though.. it's not like you take it once and say "Yay I don't have it! back to normal!".
  - mlyle 6y ago
    Testing once per week is $4 per day, which definitely adds up. But if you do this testing staggered across a population, you interrupt a whole lot of transmission chains. Not to mention a whole lot of the $30 is the disposable bluetooth scanner. If you wanted to do this kind of antigen test repeatedly at the population level you'd make different choices.
runako 6y ago
Edit: Abbott test availability Meanwhile, US-based Abbott has a $5 rapid test that is approved for use in the EU but not in the US (for home use). If we're getting rapid tests, they need to be absurdly cheap and available in great quantities. https://www.abbott.com/BinaxNOW-Test-NAVICA-App.html#/ https://www.abbott.com/BinaxNOW-Test-NAVICA-App.html#/
- dr_ 6y ago
  The Abbot rapid test is approved for use in the US, in fact I had it done on me this morning. It has almost entirely been purchased by the government for distribution to the appropriate settings (mostly healthcare/long term care settings).
  - ch4s3 6y ago
    It isn't approved for home use in the US.
    - vonmoltke 6y ago
      From what I can tell, it isn't approved for home use anywhere.
    - jcims 6y ago
      https://www.prnewswire.com/news-releases/abbotts-binaxnow-covid-19-rapid-test-receives-fda-emergency-use-authorization-for-first-virtually-guided-at-home-rapid-test-using-emeds-digital-health-platform-301194400.html https://www.prnewswire.com/news-releases/abbotts-binaxnow-co...
- Randor 6y ago
  Yep, I've heard that the actual cost of to manufacture that one was a little over $3 per unit.
- remote_phone 6y ago
  Those are the tests that gave Elon musk two false readings and two positive readings. Not super reliable either.
KingMachiavelli 6y ago
> Through a secure cloud connection, the Ellume COVID-19 Home Test provides real time reporting of test results and critical data to health authorities, employers and educators, for efficient COVID-19 mapping. [1] > Real-time reporting through secure, HIPAA compliant cloud connection [1] My understanding is that a major hurdle was the FDA requiring test results be reported back to health authorities. Or at least there has been a lot of disagreement on the issue [2]. It's a bit unclear if the reporting via the app is 100% mandatory but I would bet on it sending at least something indicating positive/negative by default. I'd expect the majority of the per unit cost to be the digital test reader and Bluetooth capability. I'm skeptical if this is anything more than a fancy camera + Bluetooth like digital pregnancy tests. [3] I'm glad we are finally getting an at home test but I can not help but think that having cheaper and simpler antigen test strips available months ago would have been a better solution. [1] https://www.ellumehealth.com/products/consumer-products/covid-home-test https://www.ellumehealth.com/products/consumer-products/covi... [2] https://www.nytimes.com/2020/09/06/health/coronavirus-rapid-test.html https://www.nytimes.com/2020/09/06/health/coronavirus-rapid-... [3] https://hackaday.com/2020/09/09/digital-pregnancy-tests-use-leds-to-read-between-the-lines/ https://hackaday.com/2020/09/09/digital-pregnancy-tests-use-...
- nitrogen 6y ago
  My understanding is that a major hurdle was the FDA requiring test results be reported back to health authorities. Or at least there has been a lot of disagreement on the issue [2]. It's a bit unclear if the reporting via the app is 100% mandatory but I would bet on it sending at least something indicating positive/negative by default. This would be a dealbreaker for me. If I'm buying a test kit it's because I want to know, not because I want the world to know.
  - save_ferris 6y ago
    > I want to know, not because I want the world to know. I understand this attitude, but just to be clear, the FDA != "the world". Their job is to protect the health of the pubic and work to mitigate the spread of a highly-contagious virus that will likely hit 2M global deaths in fairly short order. It's your choice not to take the test, but the reality is that if you've received medical care in the last 10 years, several parties probably already have access to that data. If your medical provider's EMR system uses cloud servers, then at least one of the big firms has access to it. And that's not even considering the possibility that your (anonymized) medical records haven't been sold to third parties for research purposes. Last year, outlets reported that Ascension Health, one of the largest healthcare providers in the US, was sharing medical data on millions of Americans with Google[0] without disclosure. At least in this case, you're being informed before agreeing to service how your data is going to be used. We're largely losing that right in this world. 0: https://www.engadget.com/2019-11-11-google-ascension-patient-records-project-nightingale.html https://www.engadget.com/2019-11-11-google-ascension-patient...
matz1 6y ago
The question is why would you want to buy this ?
groby_b 6y ago
Sorry, your wishes are secondary here. We're in a pandemic, and your state matters to the rest of the world. If you want to keep your health private, I suggest you close the door and stay shut in. If you want to participate in society, you have a duty towards it.
- erulabs 6y ago
  You know, not trying to bring ideology into HN, but if you just capitalize the S in state and the D in duty, what you’ve said is rather terrifying.
  - groby_b 6y ago
    Sure, if you redefine the words in a sentence, it usually says something different.
- staplers 6y ago
  Sorry, your wishes are secondary here. This attitude is a great way to keep people from taking the test, which would be a net negative towards society.
- vultour 6y ago
  What if I want to stay shut in like I've been for the past 9 months, yet want to be able to check if I somehow fall ill?
- worker767424 6y ago
  > Sorry, your wishes are secondary here. But they're not in this case because you can't force someone to take the test. I don't like this attitude from the government that people can't be trusted to be responsible adults. Same as when Fauci lied about masks to save them for healthcare workers. Let people have anonymous tests if they want, and make sure there's financial and community support for them if they do test positive, but they don't need to phone home. I'm probably visiting family for Christmas. I'm being cautious in the weeks leading up to it, but am I getting a test? No, and only because they're too hard to get. I'm not sitting in a drive-thru line for an hour for one, not even going out of my way for one. The at-home version is what I want, but I'd like to think I can be trusted to do the right thing with the results.
ilaksh 6y ago
So this is testing for an active infection right? Are there tests for antibodies and what company makes them? I know there is uncertainty about reinfection but if I knew I had antibodies it would give me some peace of mind (even if that's a bit misleading, and of course I would still wear a mask).
- standardUser 6y ago
  In many areas you can get antibody testing on demand. I recently had it done in NY at the same time I had a PCR test. I think more people should get it just so we can cut down on the number of people who blithely say "I had a tickle in my throat six months ago so I probably had COVID".
ashtonkem 6y ago
Too little, too late, at least for OECD countries. We're already starting to manufacture and distribute vaccines; ramping up new testing & tracing infrastructure is likely to have very little impact now[0], and would not be worth committing any public resources to. This might be helpful for countries that are going to be on the end of the vaccination list, but even for developing nations this will be much more expensive than vaccines (at least one company has promised to sell to poor nations at cost, which IIRC is $3-4 per shot). 0 - Test & trace is both more valuable early in the pandemic because you can save more lives, but also because these techniques have an upper limit on how many cases the system can handle. Once sizeable chunks of the population have the disease, no test & trace system cat possibly keep up. If we'd had this months ago, we possibly could have stopped this pandemic in its tracks.
- worker767424 6y ago
  I remember seeing lines of cars on the news for people getting tests before Thanksgiving, and every clinic in my area being out of appointments for tests. We knew people were going to see family for Thanksgiving, and people wanted to do be safe about it, but we didn't make it easy for them. I'll call out Fauci for not sounding the alarm on this one. He's mostly been preachy about what to do and what not to do. In September, he should have been pushing for cheap rapid tests behind the scenes. In November, he should have started saying "stay home if you can, but we know you're going to want to see family, so we made it super easy to get tested." Fauci has basically been following the sex-ed abstinence script, and it's well-documented how well that works.
Animats 6y ago
But you have to install an app on your phone, right?
orblivion 6y ago
Anybody know when this will be available? I heard in a Shepard Smith segment that it'd be available "by summer". Who cares by then? We need it yesterday.
- BurningFrog 6y ago
  It will be available around when Covid-22¶ hits
cascom 6y ago
I was excited until I found out you need to install an app on your phone to connect to the physical test to get your results...
- cbhl 6y ago
  The inside of a digital pregnancy test is literally an analog test with two lines plus some cheap electronics to read the line. Having a digital readout that says "positive" or "negative" makes these tests easier to interpret, which is important given the stakes involved. I assume that pairing the test with a phone was a compromise that cuts the need to put an LCD display on the test.
  - prepend 6y ago
    I guess it’s that, and to report the data to HHS, and to gather data for anonymization and resale as permitted by HIPAA/CLIA. I want to read the privacy policy. Edit: Couldn’t find the app yet, here’s language that I think confirms from FDA [0] “ Test results from your product will be automatically reported to relevant public health authorities, via your product’s software application (app), in accordance with local, state, and federal requirements, using appropriate LOINC and SNOMED codes, as defined by the “Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests” provided by the Centers for Disease Control and Prevention (CDC).” [0] https://www.fda.gov/media/144457/download https://www.fda.gov/media/144457/download
sradman 6y ago
The following *PCR Vs Rapid Antigen" 7min YouTube video [1] is the best summary of the Michael Mina $Dollar-a-Day-Lick-a-Stick strategy that I've come across. I find it fascinating how this seemingly simple idea has been received. We have this $30 test that wraps the paper strip antigen test in a disposable digital device that communicates via Bluetooth to a smartphone app, a $5 Abbott BinaxNOW [2] that wraps the paper strip in a folding card with a QR code that requires a technician, and the home Lucira test [3] that requires a prescription and a doctor to remotely monitor its application. We seem to be regulating for the lowest common denominator: those unable to follow a set of relatively complex instructions. I understand that the outcomes are more critical than furniture from Ikea or a cake recipe but still. There is a market for things like digital pregnancy tests because they reduce the ambiguity and user errors but it also seems unfair to prevent availability for simpler tools for people who are capable of following instructions. It seems to come down to marketing (messaging, packaging, and positioning). The Lick-a-Stick is not "a" test but a "test regiment" analogous to say a regiment of antibiotics. A positive test should be confirmed with second rapid antigen test and then an official PCR test if possible (or serum antibody tests after recovery). I think we should also refer to the paper antigen tests as "non amplified" compared to RT-PCR and RT-LAMP. The word "rapid" can apply to both styles and confuses the matter. Non amplified tests require active viral loads which is a feature not a bug (no pun intended). I think there is also a technical aspect. There should be standardized samples that can be used to certify the operating range of any test. Compared to the allies response in WWII, the Western world seems to have lost the ability to 1. identify problems, and 2. attempt to solve the problem. I thought that C.P. Snow's Two-Cultures [4] was behind us but now I'm not so sure. [1] https://youtu.be/jqdvawSUmlA https://youtu.be/jqdvawSUmlA [2] https://abbott.mediaroom.com/2020-08-26-Abbotts-Fast-5-15-Minute-Easy-to-Use-COVID-19-Antigen-Test-Receives-FDA-Emergency-Use-Authorization-Mobile-App-Displays-Test-Results-to-Help-Our-Return-to-Daily-Life-Ramping-Production-to-50-Million-Tests-a-Month https://abbott.mediaroom.com/2020-08-26-Abbotts-Fast-5-15-Mi... [3] https://www.lucirahealth.com/#the-test-kit https://www.lucirahealth.com/#the-test-kit [4] https://en.wikipedia.org/wiki/The_Two_Cultures https://en.wikipedia.org/wiki/The_Two_Cultures
dzonga 6y ago
anyways, traveling soon. which places offer cheap molecular | lab covid tests ?
mancerayder 6y ago
I have mixed feelings. It might undermine trust (already feeble in the U.S. across the board when it comes to both authority and science nowadays) if there are false results. When Musk tweeted his results of what I believe were antigen (and not PCR tests, which are more accurate), and showed contradictory results with a WTF attitude, that's an example of what we'll see more of. Musk is no shining example, but the messaging somehow needs to be "this is just a first line test, you should really rely on PCR test." That last line seems too complex, as simple as it is, to relay via the news media and 'the public.'
- artvark11 6y ago
  People will continue to test their dogs and fizzy drinks and laugh when it comes up positive.
- spacious 6y ago
  Check out https://www.rapidtests.org/ https://www.rapidtests.org/ and https://time.com/5912705/covid-19-stop-spread-christmas/ https://time.com/5912705/covid-19-stop-spread-christmas/ The tests are actually very accurate at determining contagiousness, which makes them a great tool if used in the right way.
- dawnerd 6y ago
  Musk later took two PCR tests which we conveniently heard nothing from him afterwards, so Im just assuming it came back positive and he just shut up to save face. 30 dollars for a rapid test is still too much. It needs to be something people do daily.
  - deleted 6y ago
    [deleted]
  - gpm 6y ago
    > which we conveniently heard nothing from him afterwards He reported back on the PCR tests in a fair amount of detail, tl;dr he was unambiguously positive. https://twitter.com/elonmusk/status/1328747352400785409?lang=en https://twitter.com/elonmusk/status/1328747352400785409?lang... Meta: The amount of shit he gets for things he supposedly didn't do that he did, and supposedly did do that he didn't, is amazing. There's a lot of good reasons to criticize him (and most other humans), but people are remarkably bad at criticizing him for those things, and remarkably bad at not criticizing him for other things. It must be very frustrating to be a celebrity.
kyriakos 6y ago
How easy is for an untrained person to use it?
fastball 6y ago
Sensitivity and specificity?
1-6 6y ago
-$30? That sounds reasonable, someone to pay me to take the test.
DigitalSea 6y ago
This is great news. The thing I can't understand is, Ellume is an Australian company and somehow, the US has approved these rapid testing kits and Australia has not. Just seems strange and backwards to me.
williesleg 6y ago
When do we get the test that shows you have antibodies? Amazing how nobody in the world seems to know how a common cold works. Just google it.
neonate 6y ago
The WSJ one is at https://archive.is/rubXE https://archive.is/rubXE
hedgehog 6y ago
Pictures of the inside the Ellume flu test device, I think essentially the same hardware: https://mobile.twitter.com/choongng/status/1339034619044188161 https://mobile.twitter.com/choongng/status/13390346190441881...
rawatji330171 6y ago
https://newsrepoter.com/hbo-max-will-also-be-seen-on-the-roku-player-17dec/ https://newsrepoter.com/hbo-max-will-also-be-seen-on-the-rok...
- rawatji330171 6y ago
  Nice keep it up

347 points by KoftaBob 6y ago

Can we get a better link/source? This Axios "article" doesn't have any of the details that the title of this post has (specifically ~$30 or 15min). Maybe it's just the confusing layout but the "article" under the one linked [0] does appear to have this info in it so maybe the link should be changed to that? I really hate it when news sites do this multi-article-page nonsense. It makes it so hard to link directly to information. [0] https://www.axios.com/fda-emergency-use-ellume-coronavirus-test-60152fdb-b691-4954-8068-b4d350c57ee2.html https://www.axios.com/fda-emergency-use-ellume-coronavirus-t...

monkpit 6y ago
It’s not ~$30, it’s -$30... They pay you! /s
- joshstrange 6y ago
  Hahaha, and here I thought my eyes were just playing tricks on me and I didn't look closer. I even saw the "-" and initially thought the same thing but then I, wrongly, assumed it was just the font and it was a subtle "~".
- jancsika 6y ago
  You have to break through a wall so you can approach the checkout counter from the wrong direction. But once you do it the cashier will give you $30 in "change" without you ever having paid! Only problem is when you leave you end up back in the entrance to the store, until you die.
  - selimthegrim 6y ago
    SCP or Kool-Aid Man, I have to squint to tell which

KoftaBob 6y ago

Apologies, here's a more comprehensive source with the $30 cost mentioned: https://www.nbcnews.com/health/health-news/fda-authorizes-first-home-over-counter-covid-test-n1251287 https://www.nbcnews.com/health/health-news/fda-authorizes-fi...

ortusdux 6y ago

The test is made by Ellume. Here is their press release about the approval: https://www.ellumehealth.com/2020/12/15/fda-authorizes-ellume-covid-19-home-test-as-first-over-the-counter-fully-at-home-diagnostic-test/ https://www.ellumehealth.com/2020/12/15/fda-authorizes-ellum... Here is the product page: https://www.ellumehealth.com/products/consumer-products/covid-home-test https://www.ellumehealth.com/products/consumer-products/covi... I cannot find any pricing info, but I doubt that a Bluetooth enabled at-home virus test is $30. I would image that the consumables for one test would be $30/ea.

bydo 6y ago
The Washington Post says "about $30": https://www.washingtonpost.com/health/2020/12/15/covid-home-rapid-test/ https://www.washingtonpost.com/health/2020/12/15/covid-home-...
- ortusdux 6y ago
  Interesting. The NYT says: "Each kit, which tests a single swab sample, is expected to cost about $30 or less, said Bella Zabinofsky, a spokeswoman for the company." So it sounds like a one time use kit. https://www.nytimes.com/2020/12/15/health/rapid-covid-test-ellume.html https://www.nytimes.com/2020/12/15/health/rapid-covid-test-e...
  - Balgair 6y ago
    $30 is ... a fair bit? I may be off base here, but that seems like it's a bit too expensive for a lot of people. If you could price it at a subway ride or a slice of pizza ($3 ?) that would be better. But I doubt they are trying to churn a profit here and that it costs as much because, well, it's expensive biochem.
adrian_b 6y ago
In Europe, I did such a fast test with results in 10 minutes, with visual reading, like in pregnancy tests, so no Bluetooth. The cost was less than $15, so if the Ellume test is double, then $15 would be just for the Bluetooth transceiver plus maybe a surcharge for the US market, as here all medical services are more expensive.

brandur 6y ago

For anyone else wondering about the benefits/downsides of the various tests (why do one that takes multiple days when you can do that takes 15 minutes?), the FDA has a pretty good page on this subject: https://www.fda.gov/consumers/consumer-updates/coronavirus-disease-2019-testing-basics https://www.fda.gov/consumers/consumer-updates/coronavirus-d... The tests that swab your nose or throat and take multiple days are called "molecular" tests and are considered highly accurate. They use controlled heating and cooling cycles to convert the virus' RNA to DNA, which can be detected by specialized lab technique after binding probes to it. Tests like this 15 min one are called "antigen" tests and are still accurate/helpful, but are known to produce more false negatives and false positives compared to molecular.

pmoriarty 6y ago
"Tests like this 15 min one are called "antigen" tests and are still accurate/helpful, but are known to produce more false negatives and false positives compared to molecular." On a large scale, the wrong results from such tests don't matter if you test people often enough (say, every day). If you get a wrong result one day, it'll probably be corrected in the next day or two with more tests. If there was a massive government initiative to manufacture such tests and subsidize them so that everyone got them every day this pandemic could be effectively halted in very short order, even without a vaccine. Almost 6 months ago, the This Week in Virology podcast went in to great detail about this plan, starting at about 6'20" in to episode 640: https://www.microbe.tv/twiv/twiv-640/ https://www.microbe.tv/twiv/twiv-640/ There was also at least one NYT article about it, and it was discussed on HN here: https://news.ycombinator.com/item?id=23878954 https://news.ycombinator.com/item?id=23878954 Unsurprisingly the government did not do this, and we had six more months of deaths instead.
- Analemma_ 6y ago
  > On a large scale, the wrong results from such tests don't matter if you test people often enough (say, every day). But is anyone going to be getting the test every day? Particularly when it apparently costs $30. At that price, once is fine but nobody is going to be doing it over and over; they'll just treat whatever result they get (positive or negative) as binding.

ttul 6y ago

96% sensitivity rate for people with symptoms. 91% sensitivity rate without symptoms. Given the ramp of virus replication between the time that one is asymptomatic and when one is infectious (ie hours), this sensitivity rate is excellent for an at-home test. Imagine if such a test had been available to everyone nine months ago. The pandemic could have been effectively ended.

noneeeed 6y ago
Interesting, this seems much better than the "lateral-flow" tests that we've started using in the UK for mass community testing. Apparantly those are only detecting about 50% of positive cases (not sure what the symptomatic/asymptomatic breakdown is). 90-95% sensitivity will be a real game changer.
- novok 6y ago
  There is a math that you have to apply with the amount infected. Like a test that is %99 accurate for a disease that only happens %0.001 of the time will have high false negative or positive rate, which is somewhat unexpected result. More detail: https://www.lesswrong.com/posts/XTXWPQSEgoMkAupKt/an-intuitive-explanation-of-bayes-s-theorem https://www.lesswrong.com/posts/XTXWPQSEgoMkAupKt/an-intuiti...
mrlala 6y ago
Eh not for $30 a pop though.. it's not like you take it once and say "Yay I don't have it! back to normal!".
- mlyle 6y ago
  Testing once per week is $4 per day, which definitely adds up. But if you do this testing staggered across a population, you interrupt a whole lot of transmission chains. Not to mention a whole lot of the $30 is the disposable bluetooth scanner. If you wanted to do this kind of antigen test repeatedly at the population level you'd make different choices.

runako 6y ago

Edit: Abbott test availability Meanwhile, US-based Abbott has a $5 rapid test that is approved for use in the EU but not in the US (for home use). If we're getting rapid tests, they need to be absurdly cheap and available in great quantities. https://www.abbott.com/BinaxNOW-Test-NAVICA-App.html#/ https://www.abbott.com/BinaxNOW-Test-NAVICA-App.html#/

dr_ 6y ago
The Abbot rapid test is approved for use in the US, in fact I had it done on me this morning. It has almost entirely been purchased by the government for distribution to the appropriate settings (mostly healthcare/long term care settings).
- ch4s3 6y ago
  It isn't approved for home use in the US.
  - vonmoltke 6y ago
    From what I can tell, it isn't approved for home use anywhere.
  - jcims 6y ago
    https://www.prnewswire.com/news-releases/abbotts-binaxnow-covid-19-rapid-test-receives-fda-emergency-use-authorization-for-first-virtually-guided-at-home-rapid-test-using-emeds-digital-health-platform-301194400.html https://www.prnewswire.com/news-releases/abbotts-binaxnow-co...
Randor 6y ago
Yep, I've heard that the actual cost of to manufacture that one was a little over $3 per unit.
remote_phone 6y ago
Those are the tests that gave Elon musk two false readings and two positive readings. Not super reliable either.

KingMachiavelli 6y ago

> Through a secure cloud connection, the Ellume COVID-19 Home Test provides real time reporting of test results and critical data to health authorities, employers and educators, for efficient COVID-19 mapping. [1] > Real-time reporting through secure, HIPAA compliant cloud connection [1] My understanding is that a major hurdle was the FDA requiring test results be reported back to health authorities. Or at least there has been a lot of disagreement on the issue [2]. It's a bit unclear if the reporting via the app is 100% mandatory but I would bet on it sending at least something indicating positive/negative by default. I'd expect the majority of the per unit cost to be the digital test reader and Bluetooth capability. I'm skeptical if this is anything more than a fancy camera + Bluetooth like digital pregnancy tests. [3] I'm glad we are finally getting an at home test but I can not help but think that having cheaper and simpler antigen test strips available months ago would have been a better solution. [1] https://www.ellumehealth.com/products/consumer-products/covid-home-test https://www.ellumehealth.com/products/consumer-products/covi... [2] https://www.nytimes.com/2020/09/06/health/coronavirus-rapid-test.html https://www.nytimes.com/2020/09/06/health/coronavirus-rapid-... [3] https://hackaday.com/2020/09/09/digital-pregnancy-tests-use-leds-to-read-between-the-lines/ https://hackaday.com/2020/09/09/digital-pregnancy-tests-use-...

nitrogen 6y ago
My understanding is that a major hurdle was the FDA requiring test results be reported back to health authorities. Or at least there has been a lot of disagreement on the issue [2]. It's a bit unclear if the reporting via the app is 100% mandatory but I would bet on it sending at least something indicating positive/negative by default. This would be a dealbreaker for me. If I'm buying a test kit it's because I want to know, not because I want the world to know.
- save_ferris 6y ago
  > I want to know, not because I want the world to know. I understand this attitude, but just to be clear, the FDA != "the world". Their job is to protect the health of the pubic and work to mitigate the spread of a highly-contagious virus that will likely hit 2M global deaths in fairly short order. It's your choice not to take the test, but the reality is that if you've received medical care in the last 10 years, several parties probably already have access to that data. If your medical provider's EMR system uses cloud servers, then at least one of the big firms has access to it. And that's not even considering the possibility that your (anonymized) medical records haven't been sold to third parties for research purposes. Last year, outlets reported that Ascension Health, one of the largest healthcare providers in the US, was sharing medical data on millions of Americans with Google[0] without disclosure. At least in this case, you're being informed before agreeing to service how your data is going to be used. We're largely losing that right in this world. 0: https://www.engadget.com/2019-11-11-google-ascension-patient-records-project-nightingale.html https://www.engadget.com/2019-11-11-google-ascension-patient...

matz1 6y ago

The question is why would you want to buy this ?

groby_b 6y ago

Sorry, your wishes are secondary here. We're in a pandemic, and your state matters to the rest of the world. If you want to keep your health private, I suggest you close the door and stay shut in. If you want to participate in society, you have a duty towards it.

erulabs 6y ago
You know, not trying to bring ideology into HN, but if you just capitalize the S in state and the D in duty, what you’ve said is rather terrifying.
- groby_b 6y ago
  Sure, if you redefine the words in a sentence, it usually says something different.
staplers 6y ago
Sorry, your wishes are secondary here. This attitude is a great way to keep people from taking the test, which would be a net negative towards society.
vultour 6y ago
What if I want to stay shut in like I've been for the past 9 months, yet want to be able to check if I somehow fall ill?
worker767424 6y ago
> Sorry, your wishes are secondary here. But they're not in this case because you can't force someone to take the test. I don't like this attitude from the government that people can't be trusted to be responsible adults. Same as when Fauci lied about masks to save them for healthcare workers. Let people have anonymous tests if they want, and make sure there's financial and community support for them if they do test positive, but they don't need to phone home. I'm probably visiting family for Christmas. I'm being cautious in the weeks leading up to it, but am I getting a test? No, and only because they're too hard to get. I'm not sitting in a drive-thru line for an hour for one, not even going out of my way for one. The at-home version is what I want, but I'd like to think I can be trusted to do the right thing with the results.

ilaksh 6y ago

So this is testing for an active infection right? Are there tests for antibodies and what company makes them? I know there is uncertainty about reinfection but if I knew I had antibodies it would give me some peace of mind (even if that's a bit misleading, and of course I would still wear a mask).

standardUser 6y ago
In many areas you can get antibody testing on demand. I recently had it done in NY at the same time I had a PCR test. I think more people should get it just so we can cut down on the number of people who blithely say "I had a tickle in my throat six months ago so I probably had COVID".

ashtonkem 6y ago

Too little, too late, at least for OECD countries. We're already starting to manufacture and distribute vaccines; ramping up new testing & tracing infrastructure is likely to have very little impact now[0], and would not be worth committing any public resources to. This might be helpful for countries that are going to be on the end of the vaccination list, but even for developing nations this will be much more expensive than vaccines (at least one company has promised to sell to poor nations at cost, which IIRC is $3-4 per shot). 0 - Test & trace is both more valuable early in the pandemic because you can save more lives, but also because these techniques have an upper limit on how many cases the system can handle. Once sizeable chunks of the population have the disease, no test & trace system cat possibly keep up. If we'd had this months ago, we possibly could have stopped this pandemic in its tracks.

worker767424 6y ago
I remember seeing lines of cars on the news for people getting tests before Thanksgiving, and every clinic in my area being out of appointments for tests. We knew people were going to see family for Thanksgiving, and people wanted to do be safe about it, but we didn't make it easy for them. I'll call out Fauci for not sounding the alarm on this one. He's mostly been preachy about what to do and what not to do. In September, he should have been pushing for cheap rapid tests behind the scenes. In November, he should have started saying "stay home if you can, but we know you're going to want to see family, so we made it super easy to get tested." Fauci has basically been following the sex-ed abstinence script, and it's well-documented how well that works.

Animats 6y ago

But you have to install an app on your phone, right?

orblivion 6y ago

Anybody know when this will be available? I heard in a Shepard Smith segment that it'd be available "by summer". Who cares by then? We need it yesterday.

BurningFrog 6y ago
It will be available around when Covid-22¶ hits

cascom 6y ago

I was excited until I found out you need to install an app on your phone to connect to the physical test to get your results...

cbhl 6y ago
The inside of a digital pregnancy test is literally an analog test with two lines plus some cheap electronics to read the line. Having a digital readout that says "positive" or "negative" makes these tests easier to interpret, which is important given the stakes involved. I assume that pairing the test with a phone was a compromise that cuts the need to put an LCD display on the test.
- prepend 6y ago
  I guess it’s that, and to report the data to HHS, and to gather data for anonymization and resale as permitted by HIPAA/CLIA. I want to read the privacy policy. Edit: Couldn’t find the app yet, here’s language that I think confirms from FDA [0] “ Test results from your product will be automatically reported to relevant public health authorities, via your product’s software application (app), in accordance with local, state, and federal requirements, using appropriate LOINC and SNOMED codes, as defined by the “Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests” provided by the Centers for Disease Control and Prevention (CDC).” [0] https://www.fda.gov/media/144457/download https://www.fda.gov/media/144457/download

sradman 6y ago

The following *PCR Vs Rapid Antigen" 7min YouTube video [1] is the best summary of the Michael Mina $Dollar-a-Day-Lick-a-Stick strategy that I've come across. I find it fascinating how this seemingly simple idea has been received. We have this $30 test that wraps the paper strip antigen test in a disposable digital device that communicates via Bluetooth to a smartphone app, a $5 Abbott BinaxNOW [2] that wraps the paper strip in a folding card with a QR code that requires a technician, and the home Lucira test [3] that requires a prescription and a doctor to remotely monitor its application. We seem to be regulating for the lowest common denominator: those unable to follow a set of relatively complex instructions. I understand that the outcomes are more critical than furniture from Ikea or a cake recipe but still. There is a market for things like digital pregnancy tests because they reduce the ambiguity and user errors but it also seems unfair to prevent availability for simpler tools for people who are capable of following instructions. It seems to come down to marketing (messaging, packaging, and positioning). The Lick-a-Stick is not "a" test but a "test regiment" analogous to say a regiment of antibiotics. A positive test should be confirmed with second rapid antigen test and then an official PCR test if possible (or serum antibody tests after recovery). I think we should also refer to the paper antigen tests as "non amplified" compared to RT-PCR and RT-LAMP. The word "rapid" can apply to both styles and confuses the matter. Non amplified tests require active viral loads which is a feature not a bug (no pun intended). I think there is also a technical aspect. There should be standardized samples that can be used to certify the operating range of any test. Compared to the allies response in WWII, the Western world seems to have lost the ability to 1. identify problems, and 2. attempt to solve the problem. I thought that C.P. Snow's Two-Cultures [4] was behind us but now I'm not so sure. [1] https://youtu.be/jqdvawSUmlA https://youtu.be/jqdvawSUmlA [2] https://abbott.mediaroom.com/2020-08-26-Abbotts-Fast-5-15-Minute-Easy-to-Use-COVID-19-Antigen-Test-Receives-FDA-Emergency-Use-Authorization-Mobile-App-Displays-Test-Results-to-Help-Our-Return-to-Daily-Life-Ramping-Production-to-50-Million-Tests-a-Month https://abbott.mediaroom.com/2020-08-26-Abbotts-Fast-5-15-Mi... [3] https://www.lucirahealth.com/#the-test-kit https://www.lucirahealth.com/#the-test-kit [4] https://en.wikipedia.org/wiki/The_Two_Cultures https://en.wikipedia.org/wiki/The_Two_Cultures

dzonga 6y ago

anyways, traveling soon. which places offer cheap molecular | lab covid tests ?

mancerayder 6y ago

I have mixed feelings. It might undermine trust (already feeble in the U.S. across the board when it comes to both authority and science nowadays) if there are false results. When Musk tweeted his results of what I believe were antigen (and not PCR tests, which are more accurate), and showed contradictory results with a WTF attitude, that's an example of what we'll see more of. Musk is no shining example, but the messaging somehow needs to be "this is just a first line test, you should really rely on PCR test." That last line seems too complex, as simple as it is, to relay via the news media and 'the public.'

artvark11 6y ago
People will continue to test their dogs and fizzy drinks and laugh when it comes up positive.
spacious 6y ago
Check out https://www.rapidtests.org/ https://www.rapidtests.org/ and https://time.com/5912705/covid-19-stop-spread-christmas/ https://time.com/5912705/covid-19-stop-spread-christmas/ The tests are actually very accurate at determining contagiousness, which makes them a great tool if used in the right way.
dawnerd 6y ago
Musk later took two PCR tests which we conveniently heard nothing from him afterwards, so Im just assuming it came back positive and he just shut up to save face. 30 dollars for a rapid test is still too much. It needs to be something people do daily.
- deleted 6y ago
  [deleted]
- gpm 6y ago
  > which we conveniently heard nothing from him afterwards He reported back on the PCR tests in a fair amount of detail, tl;dr he was unambiguously positive. https://twitter.com/elonmusk/status/1328747352400785409?lang=en https://twitter.com/elonmusk/status/1328747352400785409?lang... Meta: The amount of shit he gets for things he supposedly didn't do that he did, and supposedly did do that he didn't, is amazing. There's a lot of good reasons to criticize him (and most other humans), but people are remarkably bad at criticizing him for those things, and remarkably bad at not criticizing him for other things. It must be very frustrating to be a celebrity.

kyriakos 6y ago

How easy is for an untrained person to use it?

fastball 6y ago

Sensitivity and specificity?

1-6 6y ago

-$30? That sounds reasonable, someone to pay me to take the test.

DigitalSea 6y ago

This is great news. The thing I can't understand is, Ellume is an Australian company and somehow, the US has approved these rapid testing kits and Australia has not. Just seems strange and backwards to me.

williesleg 6y ago

When do we get the test that shows you have antibodies? Amazing how nobody in the world seems to know how a common cold works. Just google it.

neonate 6y ago

The WSJ one is at https://archive.is/rubXE https://archive.is/rubXE

hedgehog 6y ago

Pictures of the inside the Ellume flu test device, I think essentially the same hardware: https://mobile.twitter.com/choongng/status/1339034619044188161 https://mobile.twitter.com/choongng/status/13390346190441881...

rawatji330171 6y ago

https://newsrepoter.com/hbo-max-will-also-be-seen-on-the-roku-player-17dec/ https://newsrepoter.com/hbo-max-will-also-be-seen-on-the-rok...

rawatji330171 6y ago
Nice keep it up