
FDA grants emergency use authorization for 5-13 minute Covid-19 test - edouard-harris
https://www.abbott.com/corpnewsroom/product-and-innovation/detect-covid-19-in-as-little-as-5-minutes.html
======
edouard-harris
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.

~~~
dbrait
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.

~~~
CaptArmchair
Exactly. The problem with self testing is trust.

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.

~~~
tooltalk
> 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.

[https://thebulletin.org/2020/03/south-korea-learned-its-
succ...](https://thebulletin.org/2020/03/south-korea-learned-its-successful-
covid-19-strategy-from-a-previous-coronavirus-outbreak-mers/)

------
neuro
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_Ge...](http://www.pharmatechsolutions.co/assets/inserts/20200318_GenViro!_PP.pdf)

~~~
cameldrv
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.

~~~
jessriedel
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.

~~~
mbreese
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).

~~~
jessriedel
> 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).

~~~
mbreese
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.

~~~
jessriedel
I know nothing about the biology, but I don't think the fact that a fraudulent
company failed at a very difficult scientific problem is much evidence.

~~~
mbreese
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.

~~~
jessriedel
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.

------
mcbits
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
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-...](https://www.ssi.dk/aktuelt/nyheder/2020/03-ssi-loeser-stort-
mangelproblem-ved-test-for-covid19-27032020)

(in danish)

------
tyingq
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
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
Does it detect past infection?

~~~
jessriedel
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
I ask because I haven't yet heard of an existing antibody test for COVID-19.

~~~
sfifs
[https://www.sciencemag.org/news/2020/02/singapore-claims-
fir...](https://www.sciencemag.org/news/2020/02/singapore-claims-first-use-
antibody-test-track-coronavirus-infections#)

------
sabujp
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
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-
influen...](https://www.alere.com/en/home/product-details/id-now-influenza-
ab-2.html)

[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_r...](https://en.wikipedia.org/wiki/Nicking_enzyme_amplification_reaction)

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

------
orasis
Is there any data on the false negative rate?

~~~
hprotagonist
shocking no-one, i haven't seen a single confusion matrix in any reporting for
COVID19 test efficacy.

~~~
hamburglar1
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
well, how do you get one without the other?

either way i haven’t seen ROC, precision/recall, d’, or F1 scores either.

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

~~~
mbreese
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
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.

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

~~~
cyrux004
Yes, based on there twitter account; will be available at urgent/ER care
sometime next week

~~~
bamboozled
Thanks sorry I re-read and saw it. Let’s hope it’s real !!!

------
amelius
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
because you want to see if you have covid not a cold. I have a cold right now,
so what?

~~~
amelius
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
? 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
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.

~~~
mmmrtl
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?

------
InTheArena
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.

~~~
joe_the_user
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
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.

~~~
joe_the_user
_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.

~~~
kitteh
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.

------
jngreenlee
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.

~~~
Reelin
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
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.

~~~
csomar
> People and their doctors are the MOST concerned with their lives

That's exactly what makes them the most vulnerable. They are, in extreme
conditions, desperate for a medicine and they'll lose sense because of that.

~~~
CaptSkinny
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.

------
40four
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.

~~~
jdminhbg
> 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.

~~~
40four
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.

