
FDA just cleared a $20 Covid-19 antibody test - ck2
https://coronachecktest.com/
======
dktoao
Ummm, guys. Unsubstantiated claims along with a website clearly designed to
sell... Screams scam to me. If it is real, wait to hear about it from the CDC
or other reputable source.

~~~
ck2
[https://www.businesswire.com/news/home/20200318005814/en/](https://www.businesswire.com/news/home/20200318005814/en/)

No expert but if it was a scam wouldn't they want to sell directly to end
users?

~~~
chapium
Theranos

------
classics2
Not fda reviewed, they don’t even have permission to ship it yet, per their
own sales page.

Probably violating the master merchant agreement of every card network by
selling it at this point, so proceed with caution.

~~~
jamespullar
It does feel odd that this links directly to the sales page instead of an FDA
statement of approval. This headline should be changed. It clearly states on
the site that "This test has not been reviewed by the FDA."

~~~
classics2
I’m surprised authorize.net hasn’t slammed the door on thier merchant account
yet. Massive chargeback risk here.

------
absherwin
This is an antibody test which will only be positive days after the onset of
symptoms.

This is principally useful for several purposes:

1\. Figuring out who to isolate in hospitals if the RNA test isn't available
in sufficient quantity

2\. Understanding who has already recovered from COVID-19 and is thus immune
with all that implies in terms of inability to spread the disease and reduced
need for PPE

3\. Enabling us to confirm continued immunity later this year and understand
how long the recovered will remain immune

This is not unique to this company. It's unclear to me whether the price is
meaningfully less than competitors.

This thread is helpful for further understanding of the test and its utility:
[https://twitter.com/NAChristakis/status/1240689953895411714](https://twitter.com/NAChristakis/status/1240689953895411714)

Two more helpful references: State of testing techniques as as of a week ago:
[https://sph.nus.edu.sg/wp-
content/uploads/2020/03/COVID-19-S...](https://sph.nus.edu.sg/wp-
content/uploads/2020/03/COVID-19-Science-Report-Diagnostics-13-Mar.pdf)

The paper on which this test is based:
[https://onlinelibrary.wiley.com/doi/pdf/10.1002/jmv.25727](https://onlinelibrary.wiley.com/doi/pdf/10.1002/jmv.25727)

~~~
gridspy
Bear in mind in relation to immunity -- "Positive results may be due to past
or present infection with non-SARS-CoV-2 coronavirus strains, such as
coronavirus HKU1, NL63, OC43, or 229E."

~~~
teruakohatu
Slightly off topic question: do people who have been infected with those
varieties have any sort of immunity against covid-19?

~~~
hedora
Some health professional floated the theory that kids aren’t getting it as
much as the rest of the population because they’ve recently been hammered with
all the coronaviruses at daycare.

I’m hoping this is true, since it suggests new parents are mostly OK too.

~~~
ummonk
I keep searching for animal studies on this and come up empty - all I can find
is some studies on serological cross response when testing people for SARS
exposure.

Vaccines are obviously the best bet, but I wonder whether deliberately
exposing the healthy to common cold Coronavirus might improve herd immunity
against this Coronavirus. E.g. maybe in late summer it can be used to
forestall a second wave of Coronavirus spread in the winter.

~~~
freeone3000
Do it like we did smallpox? Worth a shot...

------
baybal2
That's an antibody test, not an RNA test. Quite a different thing.

It will only detect an infection when you have an immune response already. It
will not if you don't.

RNA tests can detect the virus even if it doesn't turn a person diseased.

~~~
erentz
One reason people seem to be missing for why antibody tests are very useful is
it will allow us to confirm those that are now immune. We can’t get this from
the RNA testing because it’s primarily being used on only symptomatic people
at the time they have symptoms (and then only if they can get the test which
typically means severe symptoms)

But if we start to test widely for antibodies we can start to clear people
from this effective quarantine/lock down situation we are going through. Those
people can then start to go back to regular life (what’s left of it), moving
around as normal, doing work helping others, so on, and that will help all of
us (and of course the economy).

I don’t know if this is something that anyone official is talking about yet,
but it seems like it should be.

~~~
throwaway2048
There is evidence that people can become re-infected, so antibodies aren't
enough.

~~~
erentz
There’s not good evidence of that. There have been cases of people testing
negative then positive again but that doesn’t mean they had cleared the virus
and got reinfected. It more likely means they had a false negative. (E.g. I
have a friend in hospital right now with COVID-19 that has had four tests, one
positive, two negative, then one positive again, all tests within the space of
four days.)

It also can be the case if you are immune compromised that you may clear the
virus through good luck, drugs, and your innate immune response. But you never
developed a good adaptive immune response and so don’t show a strong antibody
response.

Immunity to this virus may not last 10+ years, but it’s seeming unlikely that
is lasts less than 6 months.

~~~
nroets
Wouldn't it then make sense to have camps where young, healthy adults can go
to get immunity by intentionally getting infected and recover ? Then they can
go back to having normal lives. The epidemiology version of a controlled burn.

If someone take the gamble of intentionally getting the virus, his/her life
expectancy is reduced by 3 months (a ballpark figure).

If someone stay in isolation until a vaccine arrives, he/she may consider it a
greater loss.

~~~
mynegation
I am pretty sure some entertained this idea. The real problem is tail risk is
huge. If a youth gets complications or dies from the virus - is the camp
organizer responsible?

------
joezydeco
They also cleared the Pinnacle BioLabs assay. You can order a 2-pack or a
25-pack.

[https://www.pblabs.com/products/pinnacle-biolabs-
covid-19-no...](https://www.pblabs.com/products/pinnacle-biolabs-
covid-19-novel-coronavirus-dual-igg-igm-rapid-test)

Mine arrived in the mail this morning.

~~~
carlhu
The kit looks very interesting. Unfortunately, it appears to me that the
Pinnacle kit is not yet approved under the emergency fda authorization, yes?
I'm using this web page for reference: [https://www.fda.gov/medical-
devices/emergency-situations-med...](https://www.fda.gov/medical-
devices/emergency-situations-medical-devices/emergency-use-authorizations).

~~~
joezydeco
The in-vitro EUA list on the FDA page only seems to cover PCR tests and not
ELISA immunoassays (yet).

Pinnacle's webpage earlier this week said they were shipping to the EU but
waiting on the FDA EUA for shipments to the US. The tracking on my order was
marked as held up at the factory.

The EUA notice disappeared from their website on Wednesday, it shipped
yesterday, and I got it this morning.

It's reasonable to believe Pinnacle obeyed the rules and waited. My plans
weren't to use the kit unless absolutely necessary, so I can wait for the
documentation to update.

------
jupp0r
> The sensitivity is 97.90 %, the specificity is 91.77%.

This seems like it could provide a false sense of security to many if used
widely by the general population.

~~~
product50
Some smart ass always has to comment how this is not perfect and thus not
useful. Look at the alternatives. Should we just keep on waiting otherwise?

~~~
joshmaker
But there are other tests, the US just didn't use them. South Korea has had
tremendous success with testing.

> On Feb. 4, two weeks after South Korea reported its first coronavirus case,
> the government gave “emergency approval” for Seoul-based Kogene Biotech to
> move ahead with the test kits.

> Kogene currently exports test kits for the novel virus to 35 countries in
> Asia, Europe and the Middle East.

[https://www.washingtonpost.com/world/asia_pacific/coronaviru...](https://www.washingtonpost.com/world/asia_pacific/coronavirus-
test-kits-south-korea-
us/2020/03/13/007f14fc-64a1-11ea-8a8e-5c5336b32760_story.html)

> Researchers say a viral test is relatively easy to develop. Rather,
> scientists say, the chasm between the testing haves and have-nots reflects
> politics, public health strategies and, in some cases, blunders.

> South Korea opened nearly 600 testing clinics, including dozens of drive-
> through stations. More than 250,000 people have been tested

[https://www.nytimes.com/2020/03/20/world/europe/coronavirus-...](https://www.nytimes.com/2020/03/20/world/europe/coronavirus-
testing-world-countries-cities-states.html)

~~~
product50
Not true. Go deeper. There was ~10% false negatives in South Korea too. But it
is still much better than nothing. But of course no on here will say anything
about it since everything America does is likely bad and foreign countries are
always a step ahead.

------
divbzero
Has anyone found independent verification of what’s claimed in the title? “FDA
just cleared a $20 Covid-19 antibody test” does not appear on the linked
website. In fact, the website indicates that “This test has not been reviewed
by the FDA.” and I cannot find a notice from FDA’s official website regarding
an antibody test.

If the claim cannot be verified, could OP or a moderator please correct the
title?

------
jrockway
Very interesting. I am kind of curious as to whether or not I had COVID-19,
and would be willing to pay $20 to find out.

(The backstory is... I went to this party in early February. My friends were
sick and they said that there was a really strange cold going around their
office; everyone was sick, and the symptoms were different from their usual
colds. Everyone there travels like crazy. About 3 days later, I got sick, and
indeed... it was very unlike my usual colds and very much like the symptoms
associated with COVID-19. It didn't raise any alarm to me at the time, but
with a month and a half of knowledge later, it sure seems suspicious to me.)

------
yread
This group (Christian Drosten and the Dutch virologists who found a human
monoclonal antibody against COVID19) has published a paper today which seems
to be a better test:

[https://www.medrxiv.org/content/10.1101/2020.03.18.20038059v...](https://www.medrxiv.org/content/10.1101/2020.03.18.20038059v1)

------
jspash
From the website: "This test has not been reviewed by the FDA"

So which is it?

~~~
ck2
Website has not been updated. There's been news and press releases.

[https://www.biospace.com/article/releases/20-20-bioresponse-...](https://www.biospace.com/article/releases/20-20-bioresponse-
to-launch-rapid-coronavirus-test-kits-in-u-s-following-green-light-from-fda/)

The "cleared" is a bit concerning to me, it's essentially the lowest level of
"okay" \- there is all kinds of nonsense out there that is "cleared" but I
guess this is a bit of a priority.

Mass bulk testing that is $1 a hit would be better, I thought there were
machines in place that could do this and just needed reprogramming but that
doesn't seem to have ever materialized and was just another empty promise in
the moment.

~~~
ilyagr
That's an excellent link, better than the one current story points to.

> CoronaCheck was evaluated in China using 760 clinical samples. In this
> cohort, 286 samples were confirmed positive. Our manufacturers report a
> sensitivity of 97.2% and specificity of 92%.

I wonder how this compared to other tests.

------
orblivion
There was a speculation I saw on Twitter, apparently considered by some
serious people, that COVID-19 already swept through Seattle a couple months
ago and was thought to merely be a bad flu season. I personally think this
seems rather unlikely, but with an antibody test we could start to check
people who had this mysterious flu.

~~~
dan_quixote
My wife is a health care provider in Seattle (meaning that our family has much
higher than average exposure risk) and the last few months have been brutal.
We've all been sick one way or another since January and have had all the
common Covid symptoms. So I wouldn't be the least bit surprised if a test
showed I've already had it.

~~~
orblivion
If that's true, it seems to me that it would imply that this whole thing is a
mass hysteria, at least as applied to the U.S. population, since Seattle would
have looked like Italy a month ago.

~~~
dan_quixote
The total number of confirmed deaths (~250 in the US) is still incredibly low
compared to the normal number of deaths attributed to respiratory problems
over the same time range. Anecdotally, I keep hearing from other healthcare
professionals about the high number of respiratory-related deaths in hospitals
lately - most of which never get tested for Covid. I'd really like to know if
there has been a bump in respiratory deaths since January that exceeds the
number of Covid cases.

~~~
obmelvin
Same with Germany - they are likely classifying some sars-cov-2 deaths as from
another cause. Not trying to suggest any of this is being done as some sort of
cover up - given the circumstance it isn't necessarily possible to
definitively say cause of death in all situations.

------
tim333
They've had these things in china since early feb
[https://www.livemint.com/news/world/coronavirus-live-
update-...](https://www.livemint.com/news/world/coronavirus-live-update-death-
toll-crosses-800-one-in-20-people-in-wuhan-is-infected-11581217643145.html)

and you can buy similar on alibaba for 1$ but it's progress that the FDA will
eventually permit stuff I guess.

Just think if from the start they'd say just use any tests and stuff you like.
The US might not be in quite the mess it is.

------
ars
Keep in mind this is an antibody test, it only works >1 week after someone
gets sick.

It might help differentiate COVID from Flu if someone is sick, but it's not
great for screening otherwise healthy people.

~~~
joezydeco
What if you're asymptomatic?

~~~
ElijahLynn
Should work if someone is asymptomatic because it tests the antibodies that
our bodies produce after having gotten SARS-CoV-19.

------
CriticalCathed
Is this a serum or antibody test? If so, this is very good news.

If mass testing occurs we will know very soon the true nature of the disease.
For example, after serum testing for H1N1 we learned -- to our horror -- that
1.4 billion people had it. However, it also meant that H1N1 wasn't as
dangerous as we thought it was.

I hope this will give the medical community and our governments the clear data
we desperately need. The decisions our governments are making are based on
unsound data -- we are flying blind.

~~~
acchow
> after serum testing for H1N1 we learned -- to our horror -- that 1.4 billion
> people had it. However, it also meant that H1N1 wasn't as dangerous as we
> thought it was.

Citations please?

~~~
CriticalCathed
Which part? I'm happy to oblige for specifics, but it's all available on the
Wiki:

[https://en.wikipedia.org/wiki/2009_flu_pandemic](https://en.wikipedia.org/wiki/2009_flu_pandemic)

------
Animats
OK, good. With both antibody tests and virus tests available, people who have
had COVID-19 and recovered, and now presumably have immunity for some length
of time, can be identified, even if asymptomatic. They can go back to normal
life. In China, they'd be given a green card with a QR code to identify them.

How long immunity lasts after recovery is still an unknown. Maybe for life,
maybe for weeks. Repeated tests over time will tell.

------
chrisweekly
"Shipping to consumers for home use can occur only after receipt of Emergency
Use Authorization (EUA) from the U.S. FDA. Please check back for updates."

um...

------
jariel
They need to be free, universal, and possibly mandated in some areas.

Given the 'cost' is shutting down the economy and 1 trillion Fed bailout, it's
probably worth widespread distribution of these things, and nailing down
'everyone' who has it, just as S. Korea is doing. They have not 'shut down'
their country, they're just aggressive at going after cases.

~~~
chki
This test will not be able to help by shipping it out to everyone. As someone
else in this thread already described, if you give everybody in the US this
test, the probability that if someone tests positive he/she is not actually
infected is well over 99%. Also there will be a lot of cases where people are
infected but haven't had an antibody reaction yet. Those will not test
positive.

~~~
jariel
The test will still be immensely helpful.

Most people who are infected don't know it, this will tag mamy of them.

The 'false positives' can be taken care of by a visit to the hospital.

The 'no antibodies yet' can be taken care of by self-isolation - within a few
days, they'll have antibodies and can test again.

~~~
chki
>The 'false positives' can be taken care of by a visit to the hospital.

That would overwhelm hospitals immediately.

>The 'no antibodies yet' can be taken care of by self-isolation - within a few
days, they'll have antibodies and can test again.

But if the test is negative you don't know that you should self-isolate. That
would mean everybody needs to self-isolate but then we don't need the test.

~~~
jariel
No, 'positive testers' to hospitals to a proper test would not 'overwhelm'
them if it's set up right. In many places, they're setting up separate,
coronavirus clinics.

A home test would be a perfect filter for those needing proper testing.

When someone gets the 'positive' from the clinic, they can self-isolated.

If they're doing 'self-testing' once a month and it shows up negative, they
can go about their business as normal.

And when someone does test positive, they should have to notify everyone
they've been in contact with for the previous 7 days, or whoever possible.

Identification/testing/tracking will help a lot.

------
nsxwolf
Isn't "cleared" status the same thing that those laser hair regrowth hats get?

~~~
ck2
-exactly- and why it's a bit concerning but I guess right now it's all they can do to rush it out the door and cover all the mistakes made to now

"cleared" is like "won't kill you" status and that's about it

Except I guess in this case if you get a false negative you can accidentally
kill someone else?

The hindsight on this disaster a year or two from now is going to be stunning.

------
kragen
"Qualatative detection of COVID-19’s IgM and IgG antibodies"

I hope their test kits are more carefully made than their website.

I mean, normally I know it's in poor taste to criticize someone's spelling,
since what really matters is their ideas, not their educational background or
learning disabilities. But I think this case is an exception: we're talking
about a company who's claiming to offer a solution to the biggest problem in a
century — a solution that requires extreme and exacting quality-control
processes to make sure it functions correctly. An obvious spelling error on
the front page of their website could, of course, be a fluke; but it bespeaks
a company whose expertise does not include extreme and exacting quality-
control processes.

~~~
skellington
Why? That's how the test kit works. It develops colored stripes that you
QUALITATIVELY interpret. There is interpretation in the meaning of the
saturation of the strip color.

~~~
gbjw
I think they are referring to the (mis)spelling of 'qualatative.'

~~~
jacobsenscott
There are many mispelingz on there cite. It duz nut look gud 4 them atall.

------
dan_quixote
Do we know anything about the manufacturability/scalability of this test? They
say that they're about to ship 15000 test, but I'm curious how well they'll be
able to match demand.

------
ElijahLynn
It says > "This test has not been reviewed by the FDA."

~~~
ck2
[https://www.biospace.com/article/releases/20-20-bioresponse-...](https://www.biospace.com/article/releases/20-20-bioresponse-
to-launch-rapid-coronavirus-test-kits-in-u-s-following-green-light-from-fda/)

------
geuis
I think its irresponsible to leave this post undead.

------
AlexCoventry
Isn't a specificity of 92% unacceptable for a test like this?

------
ChicagoDave
Who owns the rights and are they making any profit?

~~~
forgotmyhnacc
Why does it matter?

------
tbodt
"For profesional use only"

