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.
I agree with it being a positive development, but it is probably a story for any potential second waves. Don't think it can be scaled quickly enough to change much in the current wave.
It also doesn't solve many of the spontaneous human interactions that are hurt by this. A 13 min per person test that needs to be adminstered by somebody who knows what they are doing works fine in a factory. It probably is still too much friction for a restaurant, the subway, a stadium, kid's soccer practice, etc.
If you get tested by an authority - a doctor - then there is only so much discussion to be had. Whereas if you are asked to test yourself in the morning, who's going to be able to verify your claimed outcome?
Consider STD's and - in particular - HIV. Even with medical testing, the first basic lesson any teenager (should) get(s) is to use a condom if you don't know your partner.
Moreover, it's a good thing that many legal systems (a) only grant doctors the ability to issue sick leave and (b) protect the rights of those who are issued sick leave. Labor laws being byzantine as they are, allowing employers to test their workers at their own discretion poses a wide range of prickly legal issues.
The fact that South Korea or China (arguably) succeeded in curbing their epidemic happened because their public governance puts the collective above personal rights and people are totally fine with that because that's a deep part of the moral standard of their culture.
Current mass quarantine exercises are painful in the short term, but if you can keep them up for significant time, it might be possible to safeguard liberties and protections that aren't self-evident. You could curtail those exercises and favor self testing in order to open up the economy quicker, but doing that in a meaningful way requires that we all are prepared to compromise on some of those protections and rights, with all the unintended societal consequences that might bring.
> their public governance puts the collective above personal rights and people are totally fine with that because that's a deep part of the moral standard of their culture.
I kind of disagree with that point. South Korea has succeeded in curbing the virus so far because, in large part, they are simply better prepared. To give a quick historical context, they suffered another (much smaller) coronavirus called MERS not too long ago (2015) and they ran into similar problems that many countries are now dealing with. So they spent the last 4-5 years improving their regulation (eg, quicker KFDA approval), logistics/supply chain (eg, testing kits development, distribution), and legal/public policy (eg, privacy and public disclosure) and preparing for the next virus outbreak.
So, for instance, we hear a lot about their high-tech, big-data driven tracking system (using personal GPS, credit cards data) to identify hotspots/potential contacts and isolate further infections -- that didn't exist 5 years ago during the MERS outbreak because it was thought to be intrusive and violated individual rights. The intrusive search and diagnosis strategy employed today was born out of necessity; normally not permissible under their moral or cultural code.
If it's a test you run yourself, it's absolutely true that some people won't test, or will test positive and lie about it.
As long as a large majority of people do the right thing, and report / self isolate if positive, a few people cheating here and there probably won't be enough to affect the course of the disease.
We need to remove incentives to cheat. I don't see much stigmatization of people with the disease in the USA, so that's not a worry. The biggest problem is economic, lost paychecks. We should probably require companies to allow sick leave for coronavirus, and have taxpayers pick up the tab for now.
I could imagine some sort of signed-submission system.
The test device generates a QR code you can print or screenshot, and the inspector can scan that and it's either a device-signed message or a link to a repository which would say "this test was performed by machine 123456 at 2020-04-23 10:00:20, result negative"
If someone aims to defraud the system by having someone else take the test for them, or by forging the submission system, there's probably some fraud-related legal recourse.
We can have testing stations everywhere, available to everybody, providing some kind of certificate. You would have to show this certificate when entering stadiums or restaurants to prove you're not infected.
Still not perfect, but this could be a workaround.
I have a lot of problems with this conceptually, but I think we should do something like this eventually. My biggest problem is my wife is sick, I’m not, I have a certificate that says I’m totally fine but I could now be infected, might be contaminating things, etc. What good is a certificate? We’d need to be tested almost constantly for it to mean anything.
This is a really interesting perspective on the result. I also share your optimism on what this will mean for the state of the pandemic, at least in the US for now. This very well could be the begining of the end of this crisis.
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?
That would be the case with any testing protocol, and so to the extent that it's a problem, it is a problem already. It's also a solvable one: adequate training. And people right now have a very strong incentive to pay attention and learn it properly.
Sure, but if a non professional takes a bad swab on average it wouldn't be safe to talk about deploying these to workplaces and send people back to work like Trump wants to do. Even less if you think about these people testing positive after an hour of commute on public transport.
So we allocate 0.0001% of that 2 trillion stimulus package that just passed to educate and train people on it. Worst WORST case is nothing comparable to the worst case we could face otherwise. This is an insignificant problem.
Look, you couldn't make a more wrong assertion. You would destroy countless more lives by keeping this quarantine going on indefinitely. Our economy would implode and we'd wind up in a situation far worse than what we saw during the great depression. We'd go into full stagflation and I guarantee the suicides alone would dwarf the possible death count from mass testing ppl with this device.
I am the first who wants everything to go back to normal. But have to be realistic with what is going to happen: saying that machines installed at workplaces is enough to end the pandemic is just an illusion.
As the comment made by the other user here says, it will create more waves. Now, that the damage to the economy is greater than the cost of healthcare and lives of a pandemic, that's an opinion you're not backing with data.
Also, I might be biased because I have people in my circle who are at risk, but I think a real solution is more structured than this. Machines + mandatory gloves and masks would be certainly better.
That is just a single example. You go out with your car, you get a coffee in a crowded Starbucks, go to work and test positive. Now what? There's a new cluster.
> The detection time is very fast: 5 minutes for a positive result; 13 minutes for a negative.
To quote from Abbott's press release: "delivering positive results in as little as five minutes and negative results in 13 minutes."
I'm all for fast approvals and faster testing, but let's not make this sound like it's going to be the equivalent of popping into the McDonald's drive-thru for coffee. You can drive a truck through the loop hole of "as little as...."
I think this will help, but I am not sure that an Abbott press-release deserves the breathless praise that you're giving it.
Reagents for SARS-Cov-2 testing are in short supply. How is this better in that area compared to the new Danish test that doesn't use those reagents at all?
> Then this development means the beginning of the end of the pandemic.
The end of the pandemic, even with this, is still going to be a lot more complicated. Zooming out a bit:
The third scenario is that the world plays a protracted game of whack-a-mole with the virus, stamping out outbreaks here and there until a vaccine can be produced. This is the best option, but also the longest and most complicated.
It depends, for a start, on making a vaccine. If this were a flu pandemic, that would be easier. The world is experienced at making flu vaccines and does so every year. But there are no existing vaccines for coronaviruses—until now, these viruses seemed to cause diseases that were mild or rare—so researchers must start from scratch. The first steps have been impressively quick. Last Monday, a possible vaccine created by Moderna and the National Institutes of Health went into early clinical testing. That marks a 63-day gap between scientists sequencing the virus’s genes for the first time and doctors injecting a vaccine candidate into a person’s arm. “It’s overwhelmingly the world record,” Fauci said.
But it’s also the fastest step among many subsequent slow ones.
You acknowledge you're looking at an optimistic scenario. I hope everything breaks as smoothly as you imagine.
Looking at the record of the US Federal response thus far, if anything like this level of optimism was warranted, we almost assuredly wouldn't be in the mess we are at the moment.
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.
That's a Serological test and it only goes positive about 5 days from infection, by which time you're probably not that contagious. This is a nucleic acid test which directly detects the virus and will be positive if you're contagious. They're complementary, but you need a molecular test to stop the spread. This will be a very good product.
I have no idea if the GenViro test is real/functional, but it does not claim to be a serological test. Nor is it PCR. It claims to harvest monoclonal antibodies from rats challenged with the virus, and then attaches those antibodies to the surface of an electrode in such a way that when the antibodies bind to the virus they change the electrical properties of the electrode.
That’s the opposite of what you’d want to do. You want to attach the antigen to a test and screen your body for immune cells with an antibody to the antigen. If you’re actively fighting the virus, you might see enough antigen to show a positive test. But that’s pretty iffy — especially if you’re trying to do this with a finger stick. There just isn’t enough blood to work with for most tests (see Theranos). The PCR tests require nasal or throat samples because that’s where the virus is most abundant (and accessible).
> That’s the opposite of what you’d want to do. You want to attach the antigen to a test and screen your body for immune cells with an antibody to the antigen
No, that's a serological antibody test. They are useful, but they only work once your body has already mounted a response to the virus.
In contrast, PCR tests looks for the actual viral RNA, and they work regardless of what your immune system is doing. In principle, the test I described could do likewise: it identifies the actual virus particles in the same way the (mouse) immune system does: by keying into them with antibodies which in turn trigger a larger response (the voltage).
Yeah, I get how it works but I can’t see how using a IgG probe to look for antigen would be very accurate. This is particularly true when talking about the amount of blood you get from a finger stick. The data coming out of Theranos should have made this clear.
Unless they are somehow using a glucose meter to monitor more blood than a finger stick?
I’m not doubting that you could have a test that worked by scanning for Coronavirus antigen in blood. But not with the device described here. But even assuming it worked, I don’t see how it would be better than an RNA amplification test.
The fundamental problem Theranos failed at overcoming was that you can’t accurately measure many things using small volumes of blood. All of the fraud was aimed at covering that up. (Glucose concentration is one of the few tests that does work with low volumes.) The CoV test we’re talking about has the same fundamental issue — you can’t have an accurate test for an antigen using a small amount of blood.
It’s less of a biological problem and more of a statistical sampling problem. The chances of there being a CoV antigen in the small drop of blood that you’d measure with a glucose monitor is very small. Sure, it might work, and the theory behind the device is sound. However, if you had a negative test, you’d never know if it was because you didn’t have CoV or if you just didn’t have any in that small blood sample.
I’d be happy to be wrong about this. A quick blood check as opposed to a 15min (the Abbott test) or 24hr (to 1 week with this backlog) wait would be amazing. But the amount of validation you’d need to demonstrate effectiveness would be equally amazing.
As you allude to, that's an argument based on the basic biology and statistics, not based on Theranos. You could have made that argument pre-Theranos. That Theranos tried, failed, and the covered it up is not much new evidence. Lots of companies try and fail on hard problems all the time.
Given that the above test is some random marketing PDF and I haven't heard anyone respectable talk about this mechanism, I don't have much faith in it, so that is consistent with your analysis.
The point is that it’s biologically impossible to test for some things with a finger prick. Theranos was like an electronics company claiming to have “solved” the uncertainty principle. In all these tests people are proposing, you still have to abide by the biological requirements.
My point still stands regardless of how confident you are in the biological argument: If it's biologically impossible, then you didn't learn anything from the Theranos debacle.
It still relies on a population of antibodies for detection. By the time you’ve built a good population of antibodies to trigger the test you will have been contagious for many days. This test is still very valuable though as confirmation of who has antibodies and is likely immune.
The parent is saying that the antibodies used come from an external source, not from the patient. If what the parent is saying is true, why would the patient need antibodies?
That’s not how the contagiousness works. Most reports have average of 5 days from infection to symptoms, but many people are asymptomatic or have mild symptoms. At least one study says viral shedding is close to peak the day before symptoms and the time course of shedding goes down over time. Saying you are probably not contagious just 5 days after infection is misinformation, especially since incubation can range from 2 to 14 days.
I am not an expert, but it clearly states in the link at the bottom it’s not a serology test, although they do offer a serology test strip with the meter too.
I have also read that it takes between 7 and 14 days from infection until you start to show symptoms. From your comment that would mean that anyone showing symptoms is "probably not that contagious". Given the exclusion rules rules here in the UK that doesn't sound right. What piece is missing?
The onset of symptoms starts between 2 and 14 days after infection with 3 to 6 days being the average depending on the cohort. [1] Outliers exist, such as one patient that did not show symptoms for 27 days. It is unknown when a person becomes infectious, but so far data suggests that its days before symptoms appear for most patients and as many as two thirds may be completely asymptomatic.
People show symptoms at 3 to 13 days. So, if the test is useful at 5+ days, then is should be fine for many/most sick people seeking treatment. Though yes, it would be very limited for prophylactic testing, as in testing all family/close contacts of a known infected person to see who might have caught the disease themselves.
> Today, DECN announces that the company, through its advanced development team in Korea, have finalized the configuration of the GenViro! Swift Kit test strip
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.
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.
"Officials in Spain said testing kits it bought from a Chinese company had only a 30 percent accuracy rate, rather than the 80 percent rate they had expected."
"The news comes following complaints from Spain that about 70 percent of the kits it purchased were too inaccurate to be used to diagnose patients who were sick and stuck in emergency rooms."
"Up to 80 percent of the 150,000 portable, quick coronavirus test kits China delivered to the Czech Republic earlier this month were faulty, according to local Czech news site Expats.cz."
It looks like the problem isn’t with the tests, but rather they are buying uncertified products.
From the first link,
> the company that made the test kits, Shenzhen Bioeasy Biotechnology, had not been on Beijing’s list of certified providers
> Spanish health officials said they bought the tests from an unnamed third-party distributor
Furthermore, the Spanish health officials used the test wrong,
> In a statement on social media, Bioeasy said that Spanish officials did not understand how to conduct the test and that it made videos and issued instructions to help them.
If I'm following this mess correctly, that list of certified providers didn't actually exist when Spain placed the order which would make it rather hard for them to make use of it.
Why would South Korea use Chinese testing kits when they are at least 4 biotech companies making their own testing kits (and for exports)? South Korea companies developed testing kits almost as soon as the Wuhan virus became known and have been using their own in all domestic testings.
The Government of Spain talked with WHO representatives(world's health organization) the 2th of February.
They(WHO) recommended them to buy covid fast tests. They did not. The Gov expected "one or two cases" so why the fuss?
So instead other countries(after having the same meeting with WHO) did it taking good quality test out of the market. Those are high accuracy.
But the Government of Spain waited for 9th of March to act because they wanted Women's manifestation to happen,the 8th of March, which for both parties in the Govertment(socialist and communist) was a priority over anything else(in order to show how progressive they were).
Waiting for so long meant the illness went out of control. It was too late for controlling it and a week later they recognized the problem.
So when they wanted to act they panicked and there was no good quality stock in the market, they bought what they could.
When the test kits came, they distributed to hospitals and the first thing they did was testing the kits, given the fact that they already have ill people and PCR machines(that give the results after hours or days).
They got an accuracy of just 30%, so the kits could not be used. It has been in any newspaper front page in Spain(El Español, El Pais[those are socialist so they are extra kind to the Gov], El Mundo).
So the order was cancelled.
If you know Spanish, it is extremely simple search:"test defectuosos". For example:
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?
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.
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.
> MELVILLE, N.Y.--(BUSINESS WIRE)--Mar. 26, 2020-- Henry Schein, Inc. (Nasdaq: HSIC) announced today the availability of an antibody rapid blood test, known as Standard Q COVID-19 IgM/IgG Rapid Test
...
> The Company anticipates having at least several hundred thousand tests available by March 30 and significantly increased availability beginning in April 2020.
...
> Because serology tests measure antibodies, they can help assess the likelihood of past as well as present infection, and are meant to be used as an aid to health care professionals in diagnosing the mid- to later stages of the viral infection. Along with other information, such as the presence of symptoms, the tests may help health care professionals assess whether individuals (including health care workers) have recovered from the virus.
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.
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.
There are many, especially in other countries. There are even some that one can purchase in the US, but it's not clear when (or if!) the FDA will approve these. See their Emergency Use Authorization FAQ page [1], where they list dozens of tests that are presumed to be available in the US.
There's some discussion in NY State about NYC hospitals having developed a test that's currently in use.
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 , what type is this?
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].
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%.
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.
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.
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.
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")
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.
Do you have a proposed design for such a test? I think you would be astounded by the diversity among viruses - they've been evolving for millions/billions of years, and there are an estimated 10e31 on earth
“if all the 1 × 1031 viruses on earth were laid end to end, they would stretch for 100 million light years.”
More importantly, almost adults are permanently infected with viruses like EBV. And there are genes like Arc that seem to be descended from retroviral genes. So what do you test for?
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.
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.
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.
Because western quarantine isn't true quarantine, and because what you really want to do is take every person who shows up with COVID-19 and then find out where they were for the last two weeks, and quarantine everyone they touched and do a proper quarantine on them.
But since that's not feasible, the alternative is to test as early as possible and hard-quarantine immediately -- by testing everyone constantly and everywhere, for which you really need sufficiently real-time results.
Right now, with soft-quarantine,the virus is still spreading, and the timer refreshing -- as soon as people are out and about again, rates will spike up again. Soft-quarantine is a delaying tactic (smoothening the curve), but not a solution.
But we also can't soft-quarantine for that long, because it's crushing the economy. If we keep doing it, there won't be much to go back to.
You need a test, and a fast one, or you don't have much
I’m not sure why there’s an obsession with testing right now.
Some people, grocery store workers and emergency workers are expected to be working. If you could test such workers as they show up at work, these work places would be much safer.
The "shelter in place" order is pretty as leaky as a sieve to be honest - people are still buying groceries at crowded stores because they don't have a choice. So yeah, if you could really confine everyone for three weeks, the problem would go away quicker but now, when that's not really what's happening, tests as a tool seem useful.
From what I understand it’s the asymptomatic cases that are the problem, and they’re not getting tested anyway.
When you have a ten minute test, why not test asymptomatic people?
Plus also, we need to be working hard now so we have testing, contract tracing and quarantine method available later, when they are need to "mop up" the remaining cases.
There are people who work in very essential roles (think power plants) who are already facing challenges with COVID right now. Ive heard a few stories about folks at plants where they've divided up teams in ways to prevent groups from mixing (to reduce the spread) and every time someones goes on or off shift fills out a sympton questionnaire and takes a temperature. This in addition to setting up to have people live on site. Having a ten minute test would help a ton in this area.
> If everyone is supposed to be isolating no matter what, what difference does it make if you have a covid test or not?
If we had widely available, quick, accurate testing then maybe we wouldn't need everyone to be isolating no matter what. Perhaps we still would need to for a few weeks, but not for months which would be a significant improvement.
Test are extremely important. Here in Spain, a PCR takes more or less 24h.
With fast testing you can control a pandemic BEFORE it gets out of control, like South Koread did. You control every single passenger an the border, at airports, so it does not spread to general population.
If there is someone who is not detected, when you do you control the people in their environment.
Making millions of people stay at home is a FAILURE of the system. You should control hundreds or thousands, not millions.
Robust testing is pretty likely to be an important component of whatever it is that comes after this initial wave. In a few weeks. So getting a 15 minute test like this one proved out and production scaled up is a big deal right now.
Some states need to lock down now because there are too many active cases. When the active cases get down and there are few new cases, we can end the lock down if we have cheap and abundant and quick tests, and have robust contact tracing. In addition, these measures can help us to bring down the new cases more quickly. Also, there are quite a few states where the active cases have not exploded yet. They can use these measures to avoid the fate of locking down.
If we can test and isolate, we can manage how the disease progresses through society, with a (very very slight, now) chance of stopping it. While not scientific, this is illustrative and well done that shows many aspects of disease spread:
> 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?
I'll admit that this is a hard one to explain; I've gone through a bunch of drafts for this comment.
There is a 3-5 week (1-2 weeks incubation, 1-3 weeks to resolve the symptoms) lag between infection and conclusion of the disease. So all the statistical information available to the people responding to an outbreak is weeks out of date.
They (government bodies coordinating the response) don't have a snowball's chance in hell of getting ahead of an exponential process with a doubling time of ~4 days if they only have 3-5 week old information. They need sub-24 hour feedback on what is going on. Once that is in place, targeted & proactive methods can be deployed that are less crippling than turning off entire cities.
There are already tests that can do it in 1-2 hours and without reagents that are running out. I know at least Denmark and Spain is using it (it is made in Denmark but it is published openly).
The good thing is that I doubt the factories working on either are readily interchangeable. Lab equipment companies are not going to turn out masks en masse on short notice, nor would textile companies start turning out test kits.
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.
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.
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.)
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(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.)
Yeah, seriously. Every state is happy to defy DEA with marijuana. You'd have near universal support for defying FDA in this instance, and it would be a welcome breath of fresh air for the states, who have honestly been continuously disempowered by the federal government.
In general having a drug regulatory agency is a good thing, I'd certainly agree. But the FDA is known for being excessively paranoid compared to similar bodies in other countries. So we didn't have UVA sun screen until long after Europe did, basically only have Epi-Pens which are subject to price jacks when Europe has 12 competing brands, got beta-blocking drugs a decade after Europe, etc. Though in fairness we also managed to avoid thalidomide so that's a point in the FDA's favor.
> 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.
Does it though? There's a perception that government agencies are impartial watchdogs, but this belies the reality that governments have agendas of their own. The FDA is so politically removed from the people it was created to ostensibly protect that there's now little incentive for it to relieve real suffering today. A brief example:
My brother and thousands of people suffer from type-1 diabetes. We have had the technology for years now to create an artificial pancreas, but FDA and EMA regulatory procedures have stopped any device from being sold. People are creating their own DIY systems because no commercial, professionally-developed, reasonably-priced alternative exists yet.
This isn't snake oil. There are solutions for many people's ailments available today. And the FDA is a massive giant standing in the way of people living healthier, unencumbered lives.
Treat people like adults. On the whole they're pretty good at figuring out what's best for themselves and taking care of each other.
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.
The FDA is not what is restricting your supply of 2CB, LSD, and MDMA though. I think this present crisis is a perfect illustration of why the FDA is incredibly important. Just look at all the misunderstanding about chloroquine, hyrdoxychloroquine, chloroquine sulfate, etc. flying around.
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.
Don't make the mistake of conflating concern for one's life with a desperation to avoid losing it. Safety concern is our own in-built countermeasure to desperate irrationally.
The fallacy that patients cannot act rationally in the face of adversity is a common excuse for compulsory regulatory bodies. While there is value in having a centralized body like the FDA provide consumers with qualified advice on drugs and food, a certification authority can provide that information for individuals to use at their own prerogative.
You're conflating a different issue. Congress made those drugs illegal. The FDA can't unilaterally make those legal without the support off the President or Congress.
If you want that policy to change, it'll have to happen at the voting booth, not because some FDA bureaucrat decided it.
"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).
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)
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.
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?
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.
Under your scenario you will be targeted by extremely sophisticated psy-ops (think cambridge analytica *1000) to convince you that the super-snake-oil 2xt is the absolute best cure for your disease. Don't let the gov't tell you any different. Just look at this incredibly misleading data.
That is indeed a risk factor. I've seen a lot of people argue that there's no downside, that shoving the FDA out of the way would be a pure positive, and you're right to consider that very naive.
But should we expect the FDA itself to be immune to such manipulations?
Your confidence is misplaced. I mean look at those nigerian scams, they nab people every day and they are the worst in terms of efficacy. Now up the monetary incentive to BILLIONS of dollars, and remove the FDA, and you will find extremely sophisticated players entering the game. I really don't know where you derive your "zero" number from, but I'm guessing you are thinking it will have no effect on YOU. I actually help run clinical trials and regularly advise on clinical trial read-outs, and I can assure you that I could be fooled by a sophisticated scam if I didn't have a governmental entity that can and will actually do inspections and their own investigations with the power of criminal penalty. I think your confidence is entirely misplaced.
> I mean look at those nigerian scams, they nab people every day and they are the worst in terms of efficacy.
That seems like a bad example to support your point. Nigerian scammers don't strike at random like lightning. If you aren't really stupid or really greedy, there is zero chance that you'll get scammed by those guys. They target people with poor cognitive abilities and people who are greedy enough to think they can scam the scammers.
They run dragnets looking for the rare individuals who vulnerable to their scheme. They are powerless if tasked to target a specific person unless that specific person by chance happens to be the sort of person their scheme works on.
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.
Yes, because that access is not uniformly distributed. There is a lot of disinformation, and your typical person doesn't have easy access to a lot of research sitting behind paywalls. Disinformation has much less friction, and requires much less effort to ingest, than quality research.
>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.
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.
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.
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.
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.
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
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.
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.
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.
> But, I don’t know what the benefit of a 15 minute test is.
At the risk of sounding snarky... Really? You can't think of any way in which a 5-15 min result is more valuable than a multi-hour/day result? We have governors setting up roadblocks at state borders to turn away out-of-state license plates; a quick test seems like it might help there. Then think about what that means for international flights.
Well, maybe I’ve come around after sleeping on it :) Sometimes I can’t resist an angry rant right before bed.
@mkrumm schooled me on multiple valid use cases and, I think, outlined how these things will actually be used.
They seem to allow medical professionals to be able to make rapid, urgent decisions, about specific patients or cases. Most likely in emergency situations. I doubt they can be used assembly line style to process large volumes of tests, so I’m afraid things like testing a whole plane flight or a big group of people waiting at a roadblock are not very feasible.
Ok, good thinking. Those are all pretty good use cases for a 15 minute test, assuming they can actually achieve that.
Maybe I’m just too sour and frustrated with the whole situation in the USA, and had to vent a little bit, my fault :(
This does actually sound like nice technology where they can pump out test results from this little appliance sized device on site.
Other rapid (result in hours) I’ve read about still require sending specimens to a remote lab. Let’s just hope they can manufacture them like crazy, and quickly get them to the health workers that need them most.
My elderly neighbor went to the ER complaining of shortness of breath and chest pain. They wouldn't do any heart tests until they got back the result of a covid test. They kept him for 5 days without treatment. After 5 days the test came back negative. A 15 minute test sounds good to me if it can be done on site and not shipped away for analysis.
That's not how things are typically done (in fact, I'd be very surprised if it actually took place as described by your neighbor).
One of the ways to "rule out" COVID is to confirm it's something else. Someone with the symptoms you describe would, at the very least, get an EKG and some blood work to confirm it wasn't a heart attack.
Poor guy, that doesn’t sound like a correct way to treat someone, but I am not a doctor. This is probably where this device will shine. On site, no remote lab, and allows healthcare workers to make rapid decisions for emergency situations.
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.
I think where you are going with pre-flight testing. Even if we get numbers way down by containment measures like a complete shut down, the virus will still be there and we will need to very actively test and trace (see below article). For that to work, fast test will be invaluable. Testing everyone who is traveling or going to large events or even better just going to a grocery store would really help to get back to something that's somewhat normal without having to shut everything down again periodically or losing millions of people in the process.
If you had a plane with 200 passengers and two machines at the gate, this would take an additional 25 minutes to board the flight to test everyone, assuming there is no prep, which I’m sure there is. So realistically probably an hour.
It seems like a great idea in theory, but in practice? I’m not so sure.
Considering you can have the disease and present no symptoms but be contagious, you’d have to test everyone. I guess it is better than nothing in some cases.
Are you joking? This test could be done in less than the time it took me to take off my belt, my shoes, half my clothes, then empty my pockets, then pose for the body scanner, then get the wand, then the pat down, then recover my belongings and re-dress. That was my last experience at the airport.
You're complaining that a 15 minute covid test is just too much?
I am not complaining. I'm speculating on the usefulness of thi s given that there is already a fair bit of overhead with boarding a plane in 2020 as opposed to say getting on a train.
There are a LOT of flights that happen each day, If you add up all the time combined, this would actually add a bit of overhead to an already rather long airport check-in process.
Not to mention the obvious which is that, if flights are still running at full pace, well you still have a lot of potentially infected people gathering in a rather confined area (airport), which is not really a good idea anyway.
This is obviously useful for something like triaging at a hospital, will wee see it at a check-in gate or at a bus stop? I doubt it.
Also that's clearly a lie it will take less time than for you to take off your belt, it clearly says it takes up to 15 minutes for a result. Don't talk nonsense.
Just two words: cost and benefit can help you to understand the value behind quicker tests.
Flights are getting cancelled already, and some countries closed their airports at all. There are places where you can get stuck at a border crossing, or a roadblock if you have no proof of a recent medical checks. On this background any tests which add 15 min, or even 1 hr overhead sounds more like a solution, not a problem.
No after thinking about it, I think @bamboozled is right. Testing everyone trying to board a flight, or cross a roadblock is not a feasible use case for this device. They will not be used like this. It isn’t a magic wand you can wave, there is a real bottleneck at the hardware level.
It’s not 15 mins from the time you get swabbed. It’s 15 once it’s prepared and put in the machine. Then there will be cleanup time after. Either way, even if you could run them through assembly line style every 15 minutes, 1 machine would take a whole 24 hours to process 100 people.
Another commenter @nkrumm pointed out multiple good use cases. I think they will be used to allow health care workers to make rapid decisions, for specific patients, likely in emergency situations. Not to process large volumes.
If 7500 people land in Sydney tomorrow (I think that’s the real number about to enter mandatory quarantine) even in the best case scenario using one machine without considering preparation time it will take around 1875 hours to process everyone. Around 18 hours for ten machines running, even then, that’s without prep time.
That’s a pretty long customs line.
To add to that, at a accuracy rate of 99% there will be about 75 people who will go through with the wrong diagnosis unless retests are done, which will add extra time. I really don’t see this working out at that scale.
You’d really need a sub 60 second test for this to scale.
Not sure, if you are following the news really. If there will be no possibility to check 7500, then 7500 will not be allowed. It's easy as that. Nobody will scale tests to a number of arrivals, its number of arrivals which will be scaled down. And possibility to test quickly may allow thin stream of visitors, and/or shorter quarantine terms for them.
Depending on how many people are waiting with you and how many machines they have running in parallel, it may still take two weeks for you to be cleared.
Better than nothing, but I wouldn't get too excited yet.
It’s just not what these machines are meant for clearly. The headline is catchy, but these are clearly not meant for processing huge volumes. That’s what a big lab is for. They can process huge amounts of samples in parallel.
These are for on the spot, emergency or very urgent, situations where particular patients care decisions will be determined by a rapid result.
Think at scale. Ignoring the very real human benefits because humans are impatient, a system where a single job run takes an order of magnitude less time to run has a much, much higher throughput overall, with much lower penalty when there are errors. And tired over-worked humans make mistakes. Given the extreme shortage we are under, I'd expect any of the room-sized Roche machines to be running 24/7 if there is no other bottleneck like reagents. The quicker the test, the more tests per hour or per day can be run.
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.
Blanket lockdowns are designed to dissuade city people fleeing to the countryside.
Rural areas need to be perceived as unappealing or at least having similar situations as urban/suburban areas.
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.