13 ms·

FDA grants emergency use authorization for 5-13 minute Covid-19 test

244 points by edouard-harris 7y ago

jngreenlee 7y ago
I personally hope this shows (some) irrelevance of FDA bureaucracy...if they weren't need in the worst of times, why are they needed in the best of times? Let entrepreneurs, doctors, and patients decide their individual risk level. I would rather have more options than less. Edit: as an alternative to any knee jerk critism (I said "some"), why can't states handle this and the best emerge? I'm a big proponent of localism.
- rantwasp 7y ago
  i think that in this case it's a risk trade-off. you don't want to have to make these kind of decisions daily
  - jngreenlee 7y ago
    I think my doctor and I can make those choices best from a wide spectrum of solutions, not only those lobbyied for by Giliad.
    - Reelin 7y ago
      It's worth mentioning that MDs and pharmacists in the US both have approximately 4 years of schooling (among other things) in addition to their bachelors.
    - mardifoufs 7y ago
      Okay, so the lobbying will move to doctors. And while FDA lobbying is public, good luck guessing who gave a kick back to your doc. A single regulatory body is easier to monitor than a hundred of thousands of them. Doctors getting kickbacks is already a thing so I can't imagine how it wouldn't get worst if they had the power to prescribe anything they want, not just FDA approved meds
- monksy 7y ago
  Because that is a HUGE risk involved. You can't turn back time and undo damage or bring someone back to life.
- maxerickson 7y ago
  "Stodgy gatekeeper" and "nothing" are not the only regulatory regimes available. Like you could have looser requirements to enter the market and then penalize/ban companies/people that make bad/unsafe tests. (yes, I'm proposing that people involved in marketing useless medical tests be banned from doing it a second time. Might be hard to structure it, but the goal is clear enough).
  - jngreenlee 7y ago
    I would like this, especially for tests (I understand being more restrictive for treatment but still disagree with the winner take all corpratism that results under current regime)
    - ineedasername 7y ago
      I don't see all that much "winner take all" in the medical industry. There are multiple competitors for many/most products, evidenced in this situation by many companies racing to develop & compete against each other for better testing. A few weeks ago there were news stories about rapid testing w/ 1 day turn around. Now we're down to fractions of an hour.
- hprotagonist 7y ago
  "Right To Try" is a return to legal snake oil. Hell no, get it out of here. https://blogs.sciencemag.org/pipeline/archives/2018/06/21/welcome-to-right-to-try https://blogs.sciencemag.org/pipeline/archives/2018/06/21/we... And let’s see if my nastier, more cynical Derek-Against-Humanity prediction comes true: that the next wave will not be just people who have seized on this plan opportunistically, but who have targeted it right from the start. Who will pick out terrible diseases for which there are no therapies at all, the better to insure a supply of completely desperate patients and families, and provide them with utterly useless therapies at stiff, stiff prices. Utterly harmless therapies, though – don’t want to get sued while you’re raking in the bucks. I’m talking polysaccharide therapy for pancreatic cancer, antioxidant phytonutrients for Alzheimer’s: in other words, corn starch and grape juice. What the hell. The customers are going to die, anyway. Why should they die with their money as well?
  - fortran77 7y ago
    This is still being done in the U.S. by "chiropractors" pushing their own mixtures of zinc lozenges and herbs. Google "chiropractor" and "COVID-19" if you want to be disgusted. And local news channels are reporting on this as if it's real.
  - jMyles 7y ago
    > "Right To Try" is a return to legal snake oil. Is that really so bad in 2020, when we have access to the information we actually need to learn about snake oil?
    - mardifoufs 7y ago
      Yes? Access to information does not mean access to good information. and even access to good information does not mean that people will not chose to believe debunked claims. We already have that now, but at least we can regulate what kind of claims are made and what kind of evidence is needed to make them. I'm usually all for individual responsibility, but health is one of the rare things where you can't just rely on people being rational. It is very difficult to expect rational decision making based on evidence when it comes to a dying cancer patient desperate to find a cure. And it's very easy to see people profit from that.
- Reelin 7y ago
  Woah. Hold up. I will repeatedly and loudly criticize the US government response to COVID-19 so far as inept, particularly the FDA in the early days. Brittle laws combined with their failure to move quickly hamstrung our chance at containment. Under normal circumstances though, health and safety oriented regulatory bodies such as the FDA play an absolutely essential role in protecting us from bad actors. The only reason I have confidence when purchasing medications of any sort is because of them. They also protect our food supply from all sorts of misguided and dangerous production practices. Even in an emergency situation, they have an essential role to play in preventing bad actors from popping up left and right peddling snake oil. There certainly needed to be more flexibility and speed in responding to the current crisis, and I'd argue that states ought to have _significantly_ more autonomy in a number of areas, but that's a far cry from calling them irrelevant. (As an aside, I was disappointed that none of the states defied the federal government in this instance. I had hoped for a state-level authorization for established medical labs to develop in house tests, and a subsequent court case challenging federal law on the matter. As far as I understand, the FDA only derives its authority from the frequently abused interstate commerce clause.)
  - jngreenlee 7y ago
    I think you reacted too strongly, IMO. I only said some. People and their doctors are the MOST concerned with their lives...not you, not politicians, and not FDA staffers. If I want to treat my (illegal war) PTSD, depression or anxiety with novel treatments like 2CB, LSD, or MDMA, that is my choice. It immoral to restrict my supply with the barrel of a gun.
    - Reelin 7y ago
      I completely agree - I had (mis)interpreted what you previously wrote to mean throwing them out entirely. I just can't stress enough that despite all their issues, the FDA still plays an absolutely essential role in keeping our society functioning.
    - Hello71 7y ago
      the fda doesn't regulate any of those drugs, that's the dea.
- jMyles 7y ago
  The same is true of so many of the things that are suddenly deemed unnecessary in this time of crisis. Let's be judicious about which gatekeepers and rent seekers we choose to bring back online.
- nexuist 7y ago
  >why can't states handle this and the best emerge? Is it fair to die in State X because it had more inept leaders than State Y? This isn't about long term economic or social policy, this is about an exponentially growing pandemic that doesn't respect borders.
  - tathougies 7y ago
    It's as fair as dying in Germany because France had inept leaders (for example, not saying either of those countries have inept or incompetent leadership). American states are way more autonomous than the regions of most countries. The populace elects the leaders they get.
    - ineedasername 7y ago
      It's as fair as dying in Germany because France had inept leaders Yes, which is to say it isn't fair. You're example argues for higher level oversight and uniformity of regulation, say at the EU level, not even more balkanization of them.
- xiphias2 7y ago
  The oath ,,First do no harm'' is there for a reason: sadly for most new therapies, the alternative of using the old therapy is better in 99% of the cases. The FDA is there to make sure that companies find the remaining 1%. The big difference here is that the speed of finding the right drug can make or break trillions of dollars and thousands of lives, so it's critical for the FDA to focus on the COVID-19 illness.
- jancsika 7y ago
  > Let entrepreneurs, doctors, and patients decide their individual risk level. Try starting with something less dangerous first like rolling your own ciphers for use in end-to-end encryption.
- ineedasername 7y ago
  I don't think that fracturing the regulations & approval processes into 50 different jurisdictions would be all that helpful. It would in fact greatly inhibit companies that do business in multiple states. Which set of rules do they follow? Lawsuits would abound whenever there's an issue and the rules of any jurisdiction they might operate within could be contrived to apply to the situation. And consider the current circumstances: Yes, things are relaxed in an emergency. How would that be any different? State-level, or any level of oversight, would also be relaxed in an emergency. All that shows is that sensitivity to risk changes (decreases) when there is a crisis. It doesn't invalidate the greater level of care taken when there is the time to take it. Also, no matter what level you impose oversight & regulation, patients will not be in a position to determine their desired level of risk. If it happens at the state level, there can still be plenty of people who would like a different risk threshold: They won't get it though. Finally, it ignores the fact that what might be in the best interest of a more local jurisdiction (say, it costs less money) it might be very much against the best interests of others. A jurisdiction that decides it's comfortable with higher risk does not exist in a vacuum: It's comfort with higher risk would also bleed over into neighboring areas. Far better to have a uniform set of guidelines and make exceptions on a case by case basis in emergencies, rather than make everything an exception, which would make coordination & consistency during a crisis a complete nightmare.
orasis 7y ago
Is there any data on the false negative rate?
- hprotagonist 7y ago
  shocking no-one, i haven't seen a single confusion matrix in any reporting for COVID19 test efficacy.
  - hamburglar1 7y ago
    I would say what we really care about is Sensitivity and Specificity rather than a confusion matrix, given the confusion matrix is a function of the actual positive incidence rate of the population tested and consequently a problematic measure in this case.
    - hprotagonist 7y ago
      well, how do you get one without the other? either way i haven’t seen ROC, precision/recall, d’, or F1 scores either.
- raphlinus 7y ago
  It's the same platform as runs an existing flu test. Obviously the Covid-19 version was done in a rush, so it might not be quite as good, but the sensitivity and specificity rates for influenza are amazing: sensitivity above 95% and specificity near 100%. Source: https://www.ncbi.nlm.nih.gov/pubmed/31558351 https://www.ncbi.nlm.nih.gov/pubmed/31558351
neuro 7y ago
The technology below can do it in 15 seconds. An ingenious 18 year old glucoses meter company hacked a glucose meter to do it. Interesting past between them and JNJ. They submitted it for EAU. http://www.pharmatechsolutions.co/assets/inserts/20200318_GenViro!_PP.pdf http://www.pharmatechsolutions.co/assets/inserts/20200318_Ge...
- JonathanFly 7y ago
  >An ingenious 18 year old glucoses meter company hacked a glucose meter to do it. Interesting past between them and JNJ. They submitted it for EAU. I was super impressed by this 18 year old, but the company is 18 years old. https://finance.yahoo.com/news/decn-finalizes-fda-pre-eua-141500114.html https://finance.yahoo.com/news/decn-finalizes-fda-pre-eua-14... Looks like this is a Korean developed test. Pretty cool.
  - neuro 7y ago
    It was designed in LOS ANGELES, CA. It’s within the link below https://finance.yahoo.com/news/decn-finalizes-fda-pre-eua-141500114.html https://finance.yahoo.com/news/decn-finalizes-fda-pre-eua-14...
    - dgacmu 7y ago
      > Today, DECN announces that the company, through its advanced development team in Korea, have finalized the configuration of the GenViro! Swift Kit test strip
- busymom0 7y ago
  Until it gets proven and FDA approved, I'd be skeptical. Not saying it's not possible though. Spain, Prague and Italy received tests which were 80% false so we don't want that to happen again.
  - 40four 7y ago
    I promise I’m not being a smart ass, but can you point me to a reputable source for the 80% false claim? I’ve seen a lot of people complaining of inaccurate tests, but have not come across any news articles myself. Maybe just for lack of trying :) I ask because I saw articles about rapid tests (a few hours for a result) claiming accuracy of 98% plus in South Korea. I’m not saying the info isn’t out there, I just haven’t seen it, there is too much crap flying around.
InTheArena 7y ago
The us is already running more then 100.00@ test a day which is great, and will help us on the downward side of the slope, but right now the focus needs to be on N95 masks and ventalators.
- ineedasername 7y ago
  I'm not sure I agree with your premise on tests primarily helping on the down slope. However, even if that's the case, we don't have to choose between masks, ventilators, and tests. All 3 can be pursued at the same time without harming other efforts. The manufacture & supply logistics of these items don't really overlap. No one is going to stop making & shipping masks or ventilators because of this.
- busymom0 7y ago
  > 100.00@ Did you make a typo or am I unfamiliar with that symbol? I know they are up to 100k tests per day which is supposed to go up to 150k next week.
- joe_the_user 7y ago
  Lab tests can take up to 10 days now. That's a really serious problem. A fast test would be much more useful. Of course, there are other equipment problems. N95 masks, PPE equipment, ventilators. And there's the problem of creating more quarantine areas where the infected can go and not infect their families and friends. There's problem of making the lockdowns tighter and more rational (grocery stores should be forced to do curbsite service, perhaps with grants from the state. The state could contract with Instacart also). There's the problem of more people doing contact tracing. There's the problem of prevent landlords and others from evicting and harassing health care workers (for possibly carrying the virus). There are many problems but arguing about "where the focus needs to be" seems counter-productive. All of this stuff crucial.
  - jliptzin 7y ago
    I’m not sure why there’s an obsession with testing right now. If everyone is supposed to be isolating no matter what, what difference does it make if you have a covid test or not? If you have any symptoms at all, you should stay at home and isolate at least until you’re all better, whether or not you took a COVID test. From what I understand it’s the asymptomatic cases that are the problem, and they’re not getting tested anyway. It seems to only make sense once you’re in the hospital so the doctor knows what to treat, but a test that takes 10 days to come back is useless anyway, plus there’s probably other ways for doctors to tell whether you have covid, if you’re displaying severe symptoms.
bamboozled 7y ago
When is this ready for use ? Next week ? The article didn’t say ?
- cyrux004 7y ago
  Yes, based on there twitter account; will be available at urgent/ER care sometime next week
  - bamboozled 7y ago
    Thanks sorry I re-read and saw it. Let’s hope it’s real !!!
40four 7y ago
Don’t get me wrong, I’ve been a big proponent for highly accessible, rapid testing from the get-go. But, I don’t know what the benefit of a 15 minute test is. Can anyone tell me why this is any better than the already demonstrated, very accurate, testing methods already in place? Is it just a company IP type of thing? What does it matter that we can get a result before we leave the test site, versus a few hours after we go home, eat some lunch, and do a little work? Maybe I’m overthinking it. Great. Please, Abbot, manufacture these things as fast as freaking possible. Distribute them across the whole country in huge volume. But I can’t help feel like this article (on Abbot’s own website no less) is just a bunch of sales/ marketing BS. Honestly, it mostly just pisses me off that an American company as big & powerful as Abbot, didn’t have these things ready to go from the get go. There should have been thousands of these available to every Governor in the country at least a month ago. Maybe then, our leaders (in the USA) would have had the capacity to craft smarter policies. Instead almost every governor in the country just threw blind, blanket lockdowns over entire states. Never mind that rural areas were not experiencing the same rates of infection, or pressure on health care systems, as densely populated cities. They probably just didn’t have data pints they needed to decide. So they treated everyone the same. Much to the detriment of smaller, rural regions.
- drewmol 7y ago
  Consider how effective instant read temperature tests (thermometers) are in post lock down mitigation efforts right now. Abbot is doing something at least. This article is indeed marketing material though. It makes me wonder how quickly this form of testing could be deployed across populations if IP was not enforced. Edit: I agree with your other points, although currently I feel lucky to have a pretty good governor.
- 1998v2 7y ago
  A 15 minute test could be more easily done before boarding a flight for example. I'm not sure if it is really necessary either but mentally I'm at the point where I think we should just fire all available bullets at this thing, as they become available.
  - 7y ago
mcbits 7y ago
Do these faster and faster tests all use the same reagent that has been in short supply? And has there been any progress on producing it faster, or using less of it for an accurate test?
- Dahoon 7y ago
  There's a Danish test that doesn't use those reagents that is still quick to do. It has been mailed around (Spain is using it) but I don't think there is a link online yet. https://www.ssi.dk/aktuelt/nyheder/2020/03-ssi-loeser-stort-mangelproblem-ved-test-for-covid19-27032020 https://www.ssi.dk/aktuelt/nyheder/2020/03-ssi-loeser-stort-... (in danish)
sabujp 7y ago
Can someone explain how this works? Is it an immunoassay, looks for antibodies (IgM and IgG)? I found a list of various assay types here : https://www.nature.com/articles/d41587-020-00010-2 https://www.nature.com/articles/d41587-020-00010-2 , what type is this?
- _delirium 7y ago
  This looks like it's an adaptation of the company's existing "ID NOW" equipment that was previously approved for rapid influenza detection. That test amplifies viral RNA, like the existing RT-PCR tests also do, but using a different method that is supposed to be faster but still accurate. Their influenza-test materials describe ID NOW as "isothermal nucleic acid amplification technology" [1]. According to one paper [2], it's a form of nicking enzyme amplification reaction (NEAR) [3]. [1] https://www.alere.com/en/home/product-details/id-now-influenza-ab-2.html https://www.alere.com/en/home/product-details/id-now-influen... [2] https://jcm.asm.org/content/58/3/e01611-19 https://jcm.asm.org/content/58/3/e01611-19 [3] https://en.wikipedia.org/wiki/Nicking_enzyme_amplification_reaction https://en.wikipedia.org/wiki/Nicking_enzyme_amplification_r...
amelius 7y ago
Perhaps a stupid question but why is everybody focusing on a Covid-19 test when a test for any virus (i.e. much less specific) would do as well.
- PunchTornado 7y ago
  because you want to see if you have covid not a cold. I have a cold right now, so what?
  - JshWright 7y ago
    Perhaps ironically, there's a good chance your cold is caused by a different coronavirus (there are several that are endemic in humans, and are one of the viruses that cause the "common cold")
  - amelius 7y ago
    Then you stay inside the house. Only if you have no virus (covid, cold, or otherwise) you leave the house. This is especially important for nurses, doctors, etc.
    - PunchTornado 7y ago
      ? everybody who can stays at home in my country, no matter sick or not sick. it has been now 2 weeks since I didn't go out. a side question is how a guy living alone, ordering deliveries, managing to get a cold... it must have been the deliveries.
      - amelius 7y ago
        I guess you missed the point. With a cheap and imprecise test you wouldn't need to stay home at all times (only when carrying a virus) and the economy could continue running mostly as it would normally. However, everybody seems focused on a test designed specifically for Covid-19 which means the economy will remain shut down for months to come.
alkonaut 7y ago
When they say “produce 50000 tests” do they mean 50000 of these devices? How many are already deployed?
- mbreese 7y ago
  These devices are already in doctor’s offices around the country. If you’ve ever had your GP give you an in-office Flu test, if might have been this device that ran the test. Abbott acquired the device/technology when they bought Allere a few years back. The comment on 50,000 tests would refer specifically to the test kit itself, using the existing network of devices that are already available.
  - alkonaut 7y ago
    That was what I feared. Even a small country of say 10M will need to test and re-test a significant part of the population over the coming year. Anything that won’t scale to several hundred million tests after summer isn’t very interesting. Like that device from a few days ago that could test 1000 people in a day...on 100 machines.
tyingq 7y ago
Are there any antibody tests yet? Is this an antibody test? Seems like a prerequisite if you want to get previously infected people back to work. Guessing there are a lot of people that had it, and didn't know. Senator Klobuchar seems like a good example. Her husband is hospitalized and she hasn't shown any symptoms.
- jessriedel 7y ago
  This is a PCR test, not an antibody test. That means it detects the viral RNA even before the body has mounted an immune response.
  - tyingq 7y ago
    Does it detect past infection?
    - Symmetry 7y ago
      Generally it's antibody tests that detect past infection rather than PCR tests. Technically you can find bits of viral RNA in the throat after all the live viruses are dead so you have a chance of getting a positive PCR right after a person has recovered but I don't think that's what you mean.
    - jessriedel 7y ago
      Based on my very little knowledge, I don't think so. But I think it's easy to pair it with a conventional serological antibody tests that can detect past infection. I am very far from an expert.
      - tyingq 7y ago
        I ask because I haven't yet heard of an existing antibody test for COVID-19.
        sfifs 7y ago
benchtobedside 7y ago
Any word on what the instrument and cost per sample is on this Abbott platform?
edouard-harris 7y ago
Hi - I posted this submission to HN. Based on the comments I'm seeing, it might be helpful if I clarified why I think this news is of extreme significance. The key facts are: 1. This is a test that directly detects SARS-Cov-2 virus. It can, if sensitive enough, tell you if you're infected even if you don't have any symptoms. 2. The detection time is very fast: 5 minutes for a positive result; 13 minutes for a negative. 3. The testing device is pretty compact. (Fits on a tabletop.) If, in addition to the above, the following are also true: 4. The sensitivity of the test is high enough. 5. We can quickly scale manufacture of the testing platform and its reagents. Then this development means the beginning of the end of the pandemic.* If all of the above are true, we can deploy fast testing to the entries/exits of factories, offices, etc. Folks who test positive get sent home to self-quarantine; folks who test negative can go back to work. Everyone gets ~13 minutes added to their daily commute, but they can work safely without spreading the virus. The specificity of this test almost doesn't matter. Even if flu cases trigger a positive, those folks can still be sent to secondary testing or home quarantine. The government could pay them 100% of their salary for two weeks and it would still be a fantastic deal for the rest of us. We can also ignore regulatory obstacles such as "this is only allowed in hospitals right now". The wider this testing regime is deployed, the higher a level of economic activity we can sustain while keeping R0 < 1. And given the scale of the stimulus efforts already underway, it's clear the government will do anything it can to revive the economy. Administrative barriers will be abolished as needed. Obviously this scenario is conditional on all the above actually being true. But this is the most hopeful development I've heard of since mid-February. * To be absolutely pedantic, it probably means more like a 95-98% mitigation of the pandemic within a few months.
- aledalgrande 7y ago
  How much does the quality of sampling influence the result with this machine? You're saying testing at work could be done, but what if the swab is not taken properly? Wouldn't that create a false negative?
  - chadmeister 7y ago
    This sounds like a much easier problem to solve than what we're dealing with now

I personally hope this shows (some) irrelevance of FDA bureaucracy...if they weren't need in the worst of times, why are they needed in the best of times? Let entrepreneurs, doctors, and patients decide their individual risk level. I would rather have more options than less. Edit: as an alternative to any knee jerk critism (I said "some"), why can't states handle this and the best emerge? I'm a big proponent of localism.

rantwasp 7y ago
i think that in this case it's a risk trade-off. you don't want to have to make these kind of decisions daily
- jngreenlee 7y ago
  I think my doctor and I can make those choices best from a wide spectrum of solutions, not only those lobbyied for by Giliad.
  - Reelin 7y ago
    It's worth mentioning that MDs and pharmacists in the US both have approximately 4 years of schooling (among other things) in addition to their bachelors.
  - mardifoufs 7y ago
    Okay, so the lobbying will move to doctors. And while FDA lobbying is public, good luck guessing who gave a kick back to your doc. A single regulatory body is easier to monitor than a hundred of thousands of them. Doctors getting kickbacks is already a thing so I can't imagine how it wouldn't get worst if they had the power to prescribe anything they want, not just FDA approved meds
monksy 7y ago
Because that is a HUGE risk involved. You can't turn back time and undo damage or bring someone back to life.
maxerickson 7y ago
"Stodgy gatekeeper" and "nothing" are not the only regulatory regimes available. Like you could have looser requirements to enter the market and then penalize/ban companies/people that make bad/unsafe tests. (yes, I'm proposing that people involved in marketing useless medical tests be banned from doing it a second time. Might be hard to structure it, but the goal is clear enough).
- jngreenlee 7y ago
  I would like this, especially for tests (I understand being more restrictive for treatment but still disagree with the winner take all corpratism that results under current regime)
  - ineedasername 7y ago
    I don't see all that much "winner take all" in the medical industry. There are multiple competitors for many/most products, evidenced in this situation by many companies racing to develop & compete against each other for better testing. A few weeks ago there were news stories about rapid testing w/ 1 day turn around. Now we're down to fractions of an hour.
hprotagonist 7y ago
"Right To Try" is a return to legal snake oil. Hell no, get it out of here. https://blogs.sciencemag.org/pipeline/archives/2018/06/21/welcome-to-right-to-try https://blogs.sciencemag.org/pipeline/archives/2018/06/21/we... And let’s see if my nastier, more cynical Derek-Against-Humanity prediction comes true: that the next wave will not be just people who have seized on this plan opportunistically, but who have targeted it right from the start. Who will pick out terrible diseases for which there are no therapies at all, the better to insure a supply of completely desperate patients and families, and provide them with utterly useless therapies at stiff, stiff prices. Utterly harmless therapies, though – don’t want to get sued while you’re raking in the bucks. I’m talking polysaccharide therapy for pancreatic cancer, antioxidant phytonutrients for Alzheimer’s: in other words, corn starch and grape juice. What the hell. The customers are going to die, anyway. Why should they die with their money as well?
- fortran77 7y ago
  This is still being done in the U.S. by "chiropractors" pushing their own mixtures of zinc lozenges and herbs. Google "chiropractor" and "COVID-19" if you want to be disgusted. And local news channels are reporting on this as if it's real.
- jMyles 7y ago
  > "Right To Try" is a return to legal snake oil. Is that really so bad in 2020, when we have access to the information we actually need to learn about snake oil?
  - mardifoufs 7y ago
    Yes? Access to information does not mean access to good information. and even access to good information does not mean that people will not chose to believe debunked claims. We already have that now, but at least we can regulate what kind of claims are made and what kind of evidence is needed to make them. I'm usually all for individual responsibility, but health is one of the rare things where you can't just rely on people being rational. It is very difficult to expect rational decision making based on evidence when it comes to a dying cancer patient desperate to find a cure. And it's very easy to see people profit from that.
Reelin 7y ago
Woah. Hold up. I will repeatedly and loudly criticize the US government response to COVID-19 so far as inept, particularly the FDA in the early days. Brittle laws combined with their failure to move quickly hamstrung our chance at containment. Under normal circumstances though, health and safety oriented regulatory bodies such as the FDA play an absolutely essential role in protecting us from bad actors. The only reason I have confidence when purchasing medications of any sort is because of them. They also protect our food supply from all sorts of misguided and dangerous production practices. Even in an emergency situation, they have an essential role to play in preventing bad actors from popping up left and right peddling snake oil. There certainly needed to be more flexibility and speed in responding to the current crisis, and I'd argue that states ought to have _significantly_ more autonomy in a number of areas, but that's a far cry from calling them irrelevant. (As an aside, I was disappointed that none of the states defied the federal government in this instance. I had hoped for a state-level authorization for established medical labs to develop in house tests, and a subsequent court case challenging federal law on the matter. As far as I understand, the FDA only derives its authority from the frequently abused interstate commerce clause.)
- jngreenlee 7y ago
  I think you reacted too strongly, IMO. I only said some. People and their doctors are the MOST concerned with their lives...not you, not politicians, and not FDA staffers. If I want to treat my (illegal war) PTSD, depression or anxiety with novel treatments like 2CB, LSD, or MDMA, that is my choice. It immoral to restrict my supply with the barrel of a gun.
  - Reelin 7y ago
    I completely agree - I had (mis)interpreted what you previously wrote to mean throwing them out entirely. I just can't stress enough that despite all their issues, the FDA still plays an absolutely essential role in keeping our society functioning.
  - Hello71 7y ago
    the fda doesn't regulate any of those drugs, that's the dea.
jMyles 7y ago
The same is true of so many of the things that are suddenly deemed unnecessary in this time of crisis. Let's be judicious about which gatekeepers and rent seekers we choose to bring back online.
nexuist 7y ago
>why can't states handle this and the best emerge? Is it fair to die in State X because it had more inept leaders than State Y? This isn't about long term economic or social policy, this is about an exponentially growing pandemic that doesn't respect borders.
- tathougies 7y ago
  It's as fair as dying in Germany because France had inept leaders (for example, not saying either of those countries have inept or incompetent leadership). American states are way more autonomous than the regions of most countries. The populace elects the leaders they get.
  - ineedasername 7y ago
    It's as fair as dying in Germany because France had inept leaders Yes, which is to say it isn't fair. You're example argues for higher level oversight and uniformity of regulation, say at the EU level, not even more balkanization of them.
xiphias2 7y ago
The oath ,,First do no harm'' is there for a reason: sadly for most new therapies, the alternative of using the old therapy is better in 99% of the cases. The FDA is there to make sure that companies find the remaining 1%. The big difference here is that the speed of finding the right drug can make or break trillions of dollars and thousands of lives, so it's critical for the FDA to focus on the COVID-19 illness.
jancsika 7y ago
> Let entrepreneurs, doctors, and patients decide their individual risk level. Try starting with something less dangerous first like rolling your own ciphers for use in end-to-end encryption.
ineedasername 7y ago
I don't think that fracturing the regulations & approval processes into 50 different jurisdictions would be all that helpful. It would in fact greatly inhibit companies that do business in multiple states. Which set of rules do they follow? Lawsuits would abound whenever there's an issue and the rules of any jurisdiction they might operate within could be contrived to apply to the situation. And consider the current circumstances: Yes, things are relaxed in an emergency. How would that be any different? State-level, or any level of oversight, would also be relaxed in an emergency. All that shows is that sensitivity to risk changes (decreases) when there is a crisis. It doesn't invalidate the greater level of care taken when there is the time to take it. Also, no matter what level you impose oversight & regulation, patients will not be in a position to determine their desired level of risk. If it happens at the state level, there can still be plenty of people who would like a different risk threshold: They won't get it though. Finally, it ignores the fact that what might be in the best interest of a more local jurisdiction (say, it costs less money) it might be very much against the best interests of others. A jurisdiction that decides it's comfortable with higher risk does not exist in a vacuum: It's comfort with higher risk would also bleed over into neighboring areas. Far better to have a uniform set of guidelines and make exceptions on a case by case basis in emergencies, rather than make everything an exception, which would make coordination & consistency during a crisis a complete nightmare.

orasis 7y ago

Is there any data on the false negative rate?

hprotagonist 7y ago
shocking no-one, i haven't seen a single confusion matrix in any reporting for COVID19 test efficacy.
- hamburglar1 7y ago
  I would say what we really care about is Sensitivity and Specificity rather than a confusion matrix, given the confusion matrix is a function of the actual positive incidence rate of the population tested and consequently a problematic measure in this case.
  - hprotagonist 7y ago
    well, how do you get one without the other? either way i haven’t seen ROC, precision/recall, d’, or F1 scores either.
raphlinus 7y ago
It's the same platform as runs an existing flu test. Obviously the Covid-19 version was done in a rush, so it might not be quite as good, but the sensitivity and specificity rates for influenza are amazing: sensitivity above 95% and specificity near 100%. Source: https://www.ncbi.nlm.nih.gov/pubmed/31558351 https://www.ncbi.nlm.nih.gov/pubmed/31558351

neuro 7y ago

The technology below can do it in 15 seconds. An ingenious 18 year old glucoses meter company hacked a glucose meter to do it. Interesting past between them and JNJ. They submitted it for EAU. http://www.pharmatechsolutions.co/assets/inserts/20200318_GenViro!_PP.pdf http://www.pharmatechsolutions.co/assets/inserts/20200318_Ge...

JonathanFly 7y ago
>An ingenious 18 year old glucoses meter company hacked a glucose meter to do it. Interesting past between them and JNJ. They submitted it for EAU. I was super impressed by this 18 year old, but the company is 18 years old. https://finance.yahoo.com/news/decn-finalizes-fda-pre-eua-141500114.html https://finance.yahoo.com/news/decn-finalizes-fda-pre-eua-14... Looks like this is a Korean developed test. Pretty cool.
- neuro 7y ago
  It was designed in LOS ANGELES, CA. It’s within the link below https://finance.yahoo.com/news/decn-finalizes-fda-pre-eua-141500114.html https://finance.yahoo.com/news/decn-finalizes-fda-pre-eua-14...
  - dgacmu 7y ago
    > Today, DECN announces that the company, through its advanced development team in Korea, have finalized the configuration of the GenViro! Swift Kit test strip
busymom0 7y ago
Until it gets proven and FDA approved, I'd be skeptical. Not saying it's not possible though. Spain, Prague and Italy received tests which were 80% false so we don't want that to happen again.
- 40four 7y ago
  I promise I’m not being a smart ass, but can you point me to a reputable source for the 80% false claim? I’ve seen a lot of people complaining of inaccurate tests, but have not come across any news articles myself. Maybe just for lack of trying :) I ask because I saw articles about rapid tests (a few hours for a result) claiming accuracy of 98% plus in South Korea. I’m not saying the info isn’t out there, I just haven’t seen it, there is too much crap flying around.

InTheArena 7y ago

The us is already running more then 100.00@ test a day which is great, and will help us on the downward side of the slope, but right now the focus needs to be on N95 masks and ventalators.

ineedasername 7y ago
I'm not sure I agree with your premise on tests primarily helping on the down slope. However, even if that's the case, we don't have to choose between masks, ventilators, and tests. All 3 can be pursued at the same time without harming other efforts. The manufacture & supply logistics of these items don't really overlap. No one is going to stop making & shipping masks or ventilators because of this.
busymom0 7y ago
> 100.00@ Did you make a typo or am I unfamiliar with that symbol? I know they are up to 100k tests per day which is supposed to go up to 150k next week.
joe_the_user 7y ago
Lab tests can take up to 10 days now. That's a really serious problem. A fast test would be much more useful. Of course, there are other equipment problems. N95 masks, PPE equipment, ventilators. And there's the problem of creating more quarantine areas where the infected can go and not infect their families and friends. There's problem of making the lockdowns tighter and more rational (grocery stores should be forced to do curbsite service, perhaps with grants from the state. The state could contract with Instacart also). There's the problem of more people doing contact tracing. There's the problem of prevent landlords and others from evicting and harassing health care workers (for possibly carrying the virus). There are many problems but arguing about "where the focus needs to be" seems counter-productive. All of this stuff crucial.
- jliptzin 7y ago
  I’m not sure why there’s an obsession with testing right now. If everyone is supposed to be isolating no matter what, what difference does it make if you have a covid test or not? If you have any symptoms at all, you should stay at home and isolate at least until you’re all better, whether or not you took a COVID test. From what I understand it’s the asymptomatic cases that are the problem, and they’re not getting tested anyway. It seems to only make sense once you’re in the hospital so the doctor knows what to treat, but a test that takes 10 days to come back is useless anyway, plus there’s probably other ways for doctors to tell whether you have covid, if you’re displaying severe symptoms.

bamboozled 7y ago

When is this ready for use ? Next week ? The article didn’t say ?

cyrux004 7y ago
Yes, based on there twitter account; will be available at urgent/ER care sometime next week
- bamboozled 7y ago
  Thanks sorry I re-read and saw it. Let’s hope it’s real !!!

40four 7y ago

Don’t get me wrong, I’ve been a big proponent for highly accessible, rapid testing from the get-go. But, I don’t know what the benefit of a 15 minute test is. Can anyone tell me why this is any better than the already demonstrated, very accurate, testing methods already in place? Is it just a company IP type of thing? What does it matter that we can get a result before we leave the test site, versus a few hours after we go home, eat some lunch, and do a little work? Maybe I’m overthinking it. Great. Please, Abbot, manufacture these things as fast as freaking possible. Distribute them across the whole country in huge volume. But I can’t help feel like this article (on Abbot’s own website no less) is just a bunch of sales/ marketing BS. Honestly, it mostly just pisses me off that an American company as big & powerful as Abbot, didn’t have these things ready to go from the get go. There should have been thousands of these available to every Governor in the country at least a month ago. Maybe then, our leaders (in the USA) would have had the capacity to craft smarter policies. Instead almost every governor in the country just threw blind, blanket lockdowns over entire states. Never mind that rural areas were not experiencing the same rates of infection, or pressure on health care systems, as densely populated cities. They probably just didn’t have data pints they needed to decide. So they treated everyone the same. Much to the detriment of smaller, rural regions.

drewmol 7y ago
Consider how effective instant read temperature tests (thermometers) are in post lock down mitigation efforts right now. Abbot is doing something at least. This article is indeed marketing material though. It makes me wonder how quickly this form of testing could be deployed across populations if IP was not enforced. Edit: I agree with your other points, although currently I feel lucky to have a pretty good governor.
1998v2 7y ago
A 15 minute test could be more easily done before boarding a flight for example. I'm not sure if it is really necessary either but mentally I'm at the point where I think we should just fire all available bullets at this thing, as they become available.
- 7y ago

mcbits 7y ago

Do these faster and faster tests all use the same reagent that has been in short supply? And has there been any progress on producing it faster, or using less of it for an accurate test?

Dahoon 7y ago
There's a Danish test that doesn't use those reagents that is still quick to do. It has been mailed around (Spain is using it) but I don't think there is a link online yet. https://www.ssi.dk/aktuelt/nyheder/2020/03-ssi-loeser-stort-mangelproblem-ved-test-for-covid19-27032020 https://www.ssi.dk/aktuelt/nyheder/2020/03-ssi-loeser-stort-... (in danish)

sabujp 7y ago

Can someone explain how this works? Is it an immunoassay, looks for antibodies (IgM and IgG)? I found a list of various assay types here : https://www.nature.com/articles/d41587-020-00010-2 https://www.nature.com/articles/d41587-020-00010-2 , what type is this?

_delirium 7y ago
This looks like it's an adaptation of the company's existing "ID NOW" equipment that was previously approved for rapid influenza detection. That test amplifies viral RNA, like the existing RT-PCR tests also do, but using a different method that is supposed to be faster but still accurate. Their influenza-test materials describe ID NOW as "isothermal nucleic acid amplification technology" [1]. According to one paper [2], it's a form of nicking enzyme amplification reaction (NEAR) [3]. [1] https://www.alere.com/en/home/product-details/id-now-influenza-ab-2.html https://www.alere.com/en/home/product-details/id-now-influen... [2] https://jcm.asm.org/content/58/3/e01611-19 https://jcm.asm.org/content/58/3/e01611-19 [3] https://en.wikipedia.org/wiki/Nicking_enzyme_amplification_reaction https://en.wikipedia.org/wiki/Nicking_enzyme_amplification_r...

amelius 7y ago

Perhaps a stupid question but why is everybody focusing on a Covid-19 test when a test for any virus (i.e. much less specific) would do as well.

PunchTornado 7y ago
because you want to see if you have covid not a cold. I have a cold right now, so what?
- JshWright 7y ago
  Perhaps ironically, there's a good chance your cold is caused by a different coronavirus (there are several that are endemic in humans, and are one of the viruses that cause the "common cold")
- amelius 7y ago
  Then you stay inside the house. Only if you have no virus (covid, cold, or otherwise) you leave the house. This is especially important for nurses, doctors, etc.
  - PunchTornado 7y ago
    ? everybody who can stays at home in my country, no matter sick or not sick. it has been now 2 weeks since I didn't go out. a side question is how a guy living alone, ordering deliveries, managing to get a cold... it must have been the deliveries.
    - amelius 7y ago
      I guess you missed the point. With a cheap and imprecise test you wouldn't need to stay home at all times (only when carrying a virus) and the economy could continue running mostly as it would normally. However, everybody seems focused on a test designed specifically for Covid-19 which means the economy will remain shut down for months to come.

alkonaut 7y ago

When they say “produce 50000 tests” do they mean 50000 of these devices? How many are already deployed?

mbreese 7y ago
These devices are already in doctor’s offices around the country. If you’ve ever had your GP give you an in-office Flu test, if might have been this device that ran the test. Abbott acquired the device/technology when they bought Allere a few years back. The comment on 50,000 tests would refer specifically to the test kit itself, using the existing network of devices that are already available.
- alkonaut 7y ago
  That was what I feared. Even a small country of say 10M will need to test and re-test a significant part of the population over the coming year. Anything that won’t scale to several hundred million tests after summer isn’t very interesting. Like that device from a few days ago that could test 1000 people in a day...on 100 machines.

tyingq 7y ago

Are there any antibody tests yet? Is this an antibody test? Seems like a prerequisite if you want to get previously infected people back to work. Guessing there are a lot of people that had it, and didn't know. Senator Klobuchar seems like a good example. Her husband is hospitalized and she hasn't shown any symptoms.

jessriedel 7y ago
This is a PCR test, not an antibody test. That means it detects the viral RNA even before the body has mounted an immune response.
- tyingq 7y ago
  Does it detect past infection?
  - Symmetry 7y ago
    Generally it's antibody tests that detect past infection rather than PCR tests. Technically you can find bits of viral RNA in the throat after all the live viruses are dead so you have a chance of getting a positive PCR right after a person has recovered but I don't think that's what you mean.
  - jessriedel 7y ago
    Based on my very little knowledge, I don't think so. But I think it's easy to pair it with a conventional serological antibody tests that can detect past infection. I am very far from an expert.
    - tyingq 7y ago
      I ask because I haven't yet heard of an existing antibody test for COVID-19.
      - sfifs 7y ago

benchtobedside 7y ago

Any word on what the instrument and cost per sample is on this Abbott platform?

edouard-harris 7y ago

Hi - I posted this submission to HN. Based on the comments I'm seeing, it might be helpful if I clarified why I think this news is of extreme significance. The key facts are: 1. This is a test that directly detects SARS-Cov-2 virus. It can, if sensitive enough, tell you if you're infected even if you don't have any symptoms. 2. The detection time is very fast: 5 minutes for a positive result; 13 minutes for a negative. 3. The testing device is pretty compact. (Fits on a tabletop.) If, in addition to the above, the following are also true: 4. The sensitivity of the test is high enough. 5. We can quickly scale manufacture of the testing platform and its reagents. Then this development means the beginning of the end of the pandemic.* If all of the above are true, we can deploy fast testing to the entries/exits of factories, offices, etc. Folks who test positive get sent home to self-quarantine; folks who test negative can go back to work. Everyone gets ~13 minutes added to their daily commute, but they can work safely without spreading the virus. The specificity of this test almost doesn't matter. Even if flu cases trigger a positive, those folks can still be sent to secondary testing or home quarantine. The government could pay them 100% of their salary for two weeks and it would still be a fantastic deal for the rest of us. We can also ignore regulatory obstacles such as "this is only allowed in hospitals right now". The wider this testing regime is deployed, the higher a level of economic activity we can sustain while keeping R0 < 1. And given the scale of the stimulus efforts already underway, it's clear the government will do anything it can to revive the economy. Administrative barriers will be abolished as needed. Obviously this scenario is conditional on all the above actually being true. But this is the most hopeful development I've heard of since mid-February. * To be absolutely pedantic, it probably means more like a 95-98% mitigation of the pandemic within a few months.

aledalgrande 7y ago
How much does the quality of sampling influence the result with this machine? You're saying testing at work could be done, but what if the swab is not taken properly? Wouldn't that create a false negative?
- chadmeister 7y ago
  This sounds like a much easier problem to solve than what we're dealing with now