
LabCorp’s at-home Covid-19 test kit is the first to be authorized by the FDA - jbegley
https://techcrunch.com/2020/04/21/labcorps-at-home-covid-19-test-kit-is-the-first-to-be-authorized-by-the-fda/
======
stronglikedan
$119 [0], since it's not mentioned in the article.

Also, not yet available to the masses:

> With limited quantities of kits available, Pixel by LabCorp is currently
> prioritizing healthcare workers and first responders, consistent with
> guidance from the CDC. We plan to make kits more broadly available soon so
> please check back.

[0][https://www.pixel.labcorp.com/](https://www.pixel.labcorp.com/)

~~~
fmakunbound
Anyone know if that $119 at cost? LabCorp is going to make a killing of this
crisis...

~~~
stronglikedan
Likely not "at cost", since a for-profit company should be expected to be
making a profit, but probably close, considering the herculean effort to get
these things to market, despite the red tape.

~~~
three_seagrass
The Labcorp Pixel covid kit is a mail-in sample swap for a PCR test. The
variable cost is magnitudes lower than $119.

~~~
foota
Right, but isn't there capital costs associated with being able to run them?

~~~
rjzzleep
You realize that the only reason this kit is so expensive is because the FDA
previously shut down a bunch of at home testing companies products right?

In case people forgot the first step of the FDA was to shut down at home
testing. Then they fast tracked Roche and Thermo Fischer.

Now a month later they approve an expensive at home testing kit. You take your
own conclusions of this behaviour.

[https://techcrunch.com/2020/03/23/updated-fda-
covid-19-testi...](https://techcrunch.com/2020/03/23/updated-fda-
covid-19-testing-guidelines-specifically-disallows-at-home-sample-
colllection/)

~~~
entee
Note that most of the initial tests required a nasopharyngeal swab which has
to go back into your nose several inches. I'm not surprised that the FDA
doubts that people would be able to do that reliably on their own given that
even trained people seem to get it wrong a lot (1).

The LabCorp test uses a swab that doesn't go anywhere near as deep (2). For a
test kit to be widely distributed, you need to have it be drop dead simple to
run perfectly.

Given all this, I'm not sure we should jump to corruption as the reason this
is the first at-home test.

1.) [https://slate.com/technology/2020/04/coronavirus-testing-
fal...](https://slate.com/technology/2020/04/coronavirus-testing-false-
negatives.html)

2.) [https://www.fiercebiotech.com/medtech/labcorp-s-at-home-
coro...](https://www.fiercebiotech.com/medtech/labcorp-s-at-home-coronavirus-
testing-kit-authorized-by-fda)

------
techdevangelist
What is the expectation people will actually get the swab far enough back to
collect a meaningful sample? Having been on the receiving end of a nasal
collected flu test, it was a pretty deep probing. I’m kind of doubtful most
people can do it to themself properly without some prompting to ‘go deeper’.

~~~
jacobriis
You only need to swab the edge of your nostril for this test.

[https://www.pixel.labcorp.com/covid-19-sample-
collection](https://www.pixel.labcorp.com/covid-19-sample-collection)

~~~
clumsysmurf
It was my understanding, that its easy to get false negatives with this kind
of test because the virus moves down the respiratory track as time goes on.
Too early, its not sensitive enough. Too late, nothing there. It has to be in
a specific window of opportunity. Can somebody jump in and correct me if I am
wrong?

~~~
cypherpunks01
It does move down the respiratory tract, but nasal epithelial tissue can still
contain/produce the virus for awhile even after it "moves". For me, I was able
to physically feel the inflammation move down from my throat to lungs to
abdomen, but that was 5 weeks ago, and I just tested positive on a deep nose
swab rtPCR given yesterday. A lot of people are testing positive for
surprisingly long time.

I wouldn't be surprised if a light nasal swab like being discussed here
doesn't pick up anything post-symptoms, whereas PCR with the deep nasal swab
may still be detectable for a longer time after primary symptoms have faded.

------
ianhawes
> Pixel by LabCorp™ is not available in NY, NJ, MD, or RI due to restrictions
> on how laboratory tests may be ordered. Please talk with your healthcare
> provider about options for getting tested.

Ah wonderful, so this rules out states accounting for 45% of the confirmed
cases.

~~~
joncrane
I remember when they banned 23andme in MD, I researched it and it turns out
the health insurance companies successfully lobbied against it with the
argument that information asymmetry may lead to loss of profits.

I'm still salty and I think this is part of the same scenario.

Having said that, I think Governor Hogan is one of the best governors out
there wrt state level response to Covid. Right up there with Newsom and Cuomo.

~~~
chimeracoder
> Right up there with Newsom and Cuomo.

Cuomo cut Medicaid funding by $6 billion _during_ the pandemic. He dragged his
feet on issuing a stay-at-home order for a week after the city government had
asked for one (the governor has the sole authority to authorize one in NY).
San Francisco beat Cuomo to the punch by nearly a week, even though New York
had been hit earlier and harder with COVID-19 cases. Cuomo also fought against
closing NYC schools even after the city and teachers were already on board
with the idea. As a result of New York's sluggish response, community spread
of COVID-19 happened much more rapidly than it did in other urbanized areas of
the country (most notably San Francisco), so hospitals were already overloaded
even before the stay-at-home order had been issued. On top of that, Cuomo also
expanded pretrial detention for nonviolent drug offenders during the pandemic,
which puts even more people in unnecessary close contact.
[https://nymag.com/intelligencer/2020/04/cuomo-has-learned-
no...](https://nymag.com/intelligencer/2020/04/cuomo-has-learned-nothing-from-
the-catastrophe-at-rikers.html)

As of today, 1 in 1000 New Yorkers who were alive a month ago are now dead.
Cuomo might not be the only person responsible for the current situation in
New York, but it's clear that things would be better in New York had Cuomo
taken action instead of fighting public health officials at every turn.

~~~
tathougies
Yeah, I don't know why people heap praise on Cuomo. Dude dragged his feet
compared to Newsom and the California local authorities.

~~~
renewiltord
Everyone loves a hero. California just kept things under control. No fires to
fight = no heroes.

------
LinuxBender
Does "At Home" mean at home, or send the kit from your home to their lab? It
looks like I have to ship my DNA to them. That is not "at home".

LabCorp has been hacked enough times for me to stay far away from them. I was
also not impressed with their Lab setup. I had to help other customers input
their sensitive data into LabCorp's Kiosk systems because their 2 employees
were overloaded. I am happy I left before giving them my data.

No thanks.

~~~
vl
You send your DNA to someone every time you post an envelope. LabCorp is the
largest provider doing tests, when you are tested at hospital for example,
most likely they will send your sample to them, so there is no difference with
doing it at home.

~~~
mypalmike
Nit: I dampen a towel for use with envelopes and stamps. Who wants to lick
that stuff?

------
WoodenChair
Is there a possibility of us getting an FDA sanctioned OTC antibody test in
the near future so we can find out if we already had the virus?

~~~
pmiller2
There's one available in Richmond, CA for $125:
[https://www.sfgate.com/bayarea/article/COVID-19-antibody-
tes...](https://www.sfgate.com/bayarea/article/COVID-19-antibody-testing-
available-in-Richmond-15206098.php)

~~~
renewiltord
It's $199 (+taxes).

~~~
pmiller2
It literally says $125 in the opening paragraph of the article I linked. Do
you have updated information?

~~~
renewiltord
Yes, the lab itself.
[https://app.acuityscheduling.com/schedule.php?owner=19381748](https://app.acuityscheduling.com/schedule.php?owner=19381748)

~~~
pmiller2
That seems very odd considering the SFGate article was published yesterday,
and I presume they asked the lab how much it costs. I sent the lab an email to
clarify. Let's see what they send back.

------
tomohawk
Found this:

[https://www.fda.gov/media/136151/download](https://www.fda.gov/media/136151/download)

> Negative results do not preclude SARS-CoV-2 infection and should not be used
> as the sole basis for patient management decisions. Negative results must be
> combined with clinical observations, patient history, and epidemiological
> information.

Here's a brief article that explains why observed symptoms are more important
than a test:

[https://asiatimes.com/2020/04/how-accurate-are-
coronavirus-t...](https://asiatimes.com/2020/04/how-accurate-are-coronavirus-
tests/)

------
MikeAmelung
As a childhood sufferer of semi-regular strep throat infections, I have a hard
time believing people are going to willingly jam the swab back to where it
needs to go. To me, it seems like this will just generate false negatives.

~~~
protomyth
jacobriis pointed out you only have to swab to the edge of your nostril
[https://news.ycombinator.com/item?id=22935617](https://news.ycombinator.com/item?id=22935617)

Strep tests are just a pain. Had one or two every year of high school.

------
tomohawk
Any idea what the false positive / false negative rate is?

~~~
gshdg
Yeah, haven't false negatives been a scourge of at-home testing kits released
in other countries?

------
nikofeyn
how does this help? if you can test at home, so what? how does that change
anything? it's not being tracked, can you trust results, etc.

~~~
SkyPuncher
It won't do much for most people - which is why healthcare workers and first
responders are being prioritized.

My wife is a doctor and cared for our county's first COVID-positive patient
before he was formally diagnosed (took 11 days to get test results). She was
on self-isolation for 3 weeks for late March/early April. Two weeks for the
initial exposure, 1 more week because of a low-grade fever. We're still not
certain if she had it (I got symptoms about 5 days after she did) because it
was extremely difficult to get her tested.

The challenge now is monitoring her with likely exposure when she'll be
working in-patient for the month of June. While these tests aren't perfect,
they can give us some direction on how we need handle things at home. The
price is reasonable enough that we can simply order the test for her directly
without having to call 20 different people across 3 different hospital systems
to get the sign-off on testing.

A negative doesn't tell us much (as she could still have it), but a positive
is a strong indication that she should be avoiding patient interactions and
likely self-isolating at home.

~~~
SketchySeaBeast
> A negative doesn't tell us much (as she could still have it), but a positive
> is a strong indication that she should be avoiding patient interactions and
> likely self-isolating at home.

Doesn't it only tell you if you should now be immune once your sickness is
over? Otherwise you have to act like you have it if you have the symptoms
regardless of the test. Avoiding patient interactions and self isolating
should happen regardless, shouldn't it?

~~~
SkyPuncher
In theory, yes. Sensitivity and Specificity should be considered. In practice,
there's a lot of BS going on in the healthcare system right now - these tests
are often taken at face value.

It's unfortunate, but somewhat understandable given the extreme circumstances
of our health care environment. If everyone with mild symptoms (likely not
COVID related) had to self-isolate for two weeks, we wouldn't have any
healthcare workers left to care for people.

This seems to be a "good enough" approach for most healthcare systems.

------
FootballMuse
So if I get one of these tests, and it comes back negative, what does that
mean?

~~~
SketchySeaBeast
That'll you need more testing through the rest of the pandemic until it's
either over or you come back positive.

~~~
FootballMuse
Sounds like a positive test would be a relief then.

~~~
finaliteration
I’d say it’s a relief if you test positive and then 14 days pass and you
experience no or mild symptoms. But I know for me, personally, I’d be a
nervous wreck during that period waiting for the symptoms to come (but I also
have an underlying respiratory condition so that’s a big part of my anxiety).

~~~
SketchySeaBeast
My concern here is why did you pay over $100 when you felt fine? How often
would someone sample themselves without symptoms?

~~~
finaliteration
That’s a fair question. I do think some people may buy and take the test if
they’ve been in an area where the potential for exposure is high and they
worry they are an asymptomatic or presymptomatic carrier.

------
mdszy
Expecting profit during a catastrophe is exactly why the sitaution is as shit
as it is right now.

~~~
Teever
How have you been foregoing profit for your work during this calamitous time?
Have you been laid off like many people or are you simply returning the
cheques that your employer sends you?

Personally I've been continuing to show up for work despite my employer not
having sufficient funds to pay me but I understand that every situation is
different.

~~~
claudeganon
Profit != wages. A company profiting off a test is not the same as a worker
being paid for their labor. Something being made at cost would price in the
cost of labor, while profit is in excess of that (and all other expenses).

~~~
revnode
I would say anything above your costs of living would be profit in a wage, no?

------
needle0
So this has you take a sample and ship it to their lab. How is this going to
deal with the risk of biohazard for parcel delivery personnel?

~~~
stronglikedan
It's no more risky than anything else an already infected person may ship,
which is why the parcel delivery companies likely already have sufficient
mitigation efforts in place.

------
ck2
Well, it's three months and 40,000 deaths late but it's a start.

But there needs to be anonymous antibody testing at home like a pregnancy
test.

BTW also needs the post office properly funded and saved from bankruptcy. WTF
are we bailing out cruise ships and not the post office?

~~~
renewiltord
Well considering it's been three months and 40k deaths and you have given us
nothing, I'm going to go with the guy who gave me something.

------
LatteLazy
Before people get excited that the FDA approved something, how much testing
have the FDA done on this product and how many other tests have they declined
to authorize?

Right now, FDA approved means about as much as Probably not immediately
lethal.

