11 ms·

FDA just cleared a $20 Covid-19 antibody test

302 points by ck2 7y ago

Animats 7y ago
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.
joezydeco 7y ago
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-novel-coronavirus-dual-igg-igm-rapid-test https://www.pblabs.com/products/pinnacle-biolabs-covid-19-no... Mine arrived in the mail this morning.
- carlhu 7y ago
  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-medical-devices/emergency-use-authorizations https://www.fda.gov/medical-devices/emergency-situations-med....
  - joezydeco 7y ago
    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.
- WoodenChair 7y ago
  Are there any reviews? Any third party verification? How do I know that this is legitimate? These are sincere questions, I'm not just being difficult.
  - scrollaway 7y ago
    Isn't FDA clearance the very definition of "third party verification"?
    - imperio59 7y ago
      Looks like they got a CE seal on Feb 20, per their website. That's something at least.
      - WoodenChair 7y ago
        Can we trust their website? Is it on another website somewhere?
    - WoodenChair 7y ago
      Is it on the FDA website somewhere?
- aqme28 7y ago
  Did you buy it for some sort of industry use, or as a regular consumer for personal testing?
  - joezydeco 7y ago
    Personal use. I ordered it weeks ago purely as a hypothetical. If I was home sick with a flu, was it seasonal or was it nCov? This was before all the lockdowns started. I also bought a fingertip pulse oximeter for the same reason. I’m surprised those haven’t been hoarded...yet.
- amvalo 7y ago
  Seems to be a scam. If you look up their FDA registration number nothing shows up.
  - joezydeco 7y ago
    I’ve used some of their other home testing kits before, like their colon cancer screening kit. Detects globin at 50 ng/mL and is board approved by gastroenterologists. The company isn’t a scam.
    - amvalo 7y ago
      Yeah, after digging into it more I saw that. Doesn't explain the missing FDA number though which is quite sketchy.
      - joezydeco 7y ago
        Their number is listed in the info brochure. https://cdn.shopify.com/s/files/1/1010/0544/files/COVID19BrochureFront.pdf?v=1583766247 https://cdn.shopify.com/s/files/1/1010/0544/files/COVID19Bro...
        amvalo 7y ago
        Yeah, and it's not listed... in the actual FDA database.
        joezydeco 7y ago
        Found it in 3 clicks. Maybe it's been recently updated? https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=172941 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.c... https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=651998&lpcd=QJR https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.c...
        amvalo 7y ago
- romski 7y ago
  Link already removed :-(
jspash 7y ago
From the website: "This test has not been reviewed by the FDA" So which is it?
- ck2 7y ago
  Website has not been updated. There's been news and press releases. https://www.biospace.com/article/releases/20-20-bioresponse-to-launch-rapid-coronavirus-test-kits-in-u-s-following-green-light-from-fda/ https://www.biospace.com/article/releases/20-20-bioresponse-... 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 7y ago
    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.
baybal2 7y ago
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.
- gopalv 7y ago
  > That's an antibody test, not an RNA test. Yes, this is an exposure test - which works okay for a completely novel virus like this one. The real question is whether this has a drop-off factor for immunity for instance (i.e non-infectious herd immune) or if it can differentiate between exposure and carrier for the disease. It might be useful right now, but it will get less useful as the months go by. For instance, the QuantiFeron test for TB tests me as positive because my white blood cells take TB very seriously (or so it looks like).
- whateveracct 7y ago
  Surely still important progress & a big deal though, right?
  - lisper 7y ago
    This will make it easier to tell if a symptomatic person has COVID or something else. But it won't help with early detection, which is what is most urgently needed.
    - noelsusman 7y ago
      We needed early detection weeks ago. That ship has sailed. At this point a test like this is probably more urgent. The lead time on getting tests for patients showing up to the hospital (i.e. they have symptoms) will make a massive difference in how much PPE the hospital goes through.
    - dogma1138 7y ago
      Early detection is utterly irrelevant at this point it’s endemic at most places now.
deleted 7y ago
[deleted]
ars 7y ago
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 7y ago
  What if you're asymptomatic?
  - ElijahLynn 7y ago
    Should work if someone is asymptomatic because it tests the antibodies that our bodies produce after having gotten SARS-CoV-19.
  - ars 7y ago
    According to the logo on this graph, it only works 7 days after symptoms appear: https://coronachecktest.com/wp-content/uploads/2020/03/antibody-chart-cropped-1.jpg https://coronachecktest.com/wp-content/uploads/2020/03/antib...
- gpm 7y ago
  I'm curious what you're basing the 1 week off of? As far as I can tell the company isn't reporting any data about how long it takes, but they think that it is likely to be similar to SARS per their manuscript: https://coronachecktest.com/wp-content/uploads/2020/03/Development-and-Clinical-Application.pdf https://coronachecktest.com/wp-content/uploads/2020/03/Devel... > It was reported that after SARS infection, IgM antibody could be detected in patient blood after 3-6 days and IgG could be detected after 8 days. Since COVID-19 belongs to the same large family of viruses as those that cause the MERS and SARS outbreak, we assume its antibody generation process is similar, and detection of the IgG and IgM antibody against SARS-CoV-2 will be an indication of infection.
  - ars 7y ago
    > I'm curious what you're basing the 1 week off of? There is a graph at the bottom of their homepage: https://coronachecktest.com/wp-content/uploads/2020/03/antibody-chart-cropped-1.jpg https://coronachecktest.com/wp-content/uploads/2020/03/antib... The first red dot is at the 7 day mark.
ElijahLynn 7y ago
It says > "This test has not been reviewed by the FDA."
- ck2 7y ago
  https://www.biospace.com/article/releases/20-20-bioresponse-to-launch-rapid-coronavirus-test-kits-in-u-s-following-green-light-from-fda/ https://www.biospace.com/article/releases/20-20-bioresponse-...
jupp0r 7y ago
> 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 7y ago
  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?
  - cma 7y ago
    It is probably useful for getting population statistics and directing higher level actions, or even at some point overquarantining people based on positives and false positives, but people that get a false sense of security are a risk. There was an article about a village leader who tested negative and had 200 villagers come to congratulate him, then he tested positive on a subsequent test.
  - joshmaker 7y ago
    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/coronavirus-test-kits-south-korea-us/2020/03/13/007f14fc-64a1-11ea-8a8e-5c5336b32760_story.html https://www.washingtonpost.com/world/asia_pacific/coronaviru... > 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-testing-world-countries-cities-states.html https://www.nytimes.com/2020/03/20/world/europe/coronavirus-...
    - 7y ago
dktoao 7y ago
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.
- chapium 7y ago
  Its so easy to take in news we want to hear. You are right, this needs better sources.
- ck2 7y ago
  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 7y ago
    Theranos
kragen 7y ago
"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 7y ago
  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 7y ago
    I think they are referring to the (mis)spelling of 'qualatative.'
    - jacobsenscott 7y ago
      There are many mispelingz on there cite. It duz nut look gud 4 them atall.
nsxwolf 7y ago
Isn't "cleared" status the same thing that those laser hair regrowth hats get?
- ck2 7y ago
  -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.
jariel 7y ago
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 7y ago
  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 7y ago
    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 7y ago
      >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 7y ago
        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.
CriticalCathed 7y ago
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 7y ago
  > 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 7y ago
    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
chrisweekly 7y ago
"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...
absherwin 7y ago
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-Science-Report-Diagnostics-13-Mar.pdf https://sph.nus.edu.sg/wp-content/uploads/2020/03/COVID-19-S... 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
- BurningFrog 7y ago
  A test for who is immune seems very important a few months down the road!
  - munk-a 7y ago
    Oh that's easy - just find one of those Floridian beach goers. Anyone still fine in three weeks is immune.
- gridspy 7y ago
  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 7y ago
    Slightly off topic question: do people who have been infected with those varieties have any sort of immunity against covid-19?
deleted 7y ago
[deleted]
classics2 7y ago
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 7y ago
  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 7y ago
    I’m surprised authorize.net hasn’t slammed the door on thier merchant account yet. Massive chargeback risk here.
- ck2 7y ago
  https://www.businesswire.com/news/home/20200318005814/en/ https://www.businesswire.com/news/home/20200318005814/en/
yread 7y ago
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/10.1101/2020.03.18.20038059v1 https://www.medrxiv.org/content/10.1101/2020.03.18.20038059v...
tbodt 7y ago
"For profesional use only"
orblivion 7y ago
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 7y ago
  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 7y ago
    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 7y ago
      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 7y ago
        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.
ChicagoDave 7y ago
Who owns the rights and are they making any profit?
- forgotmyhnacc 7y ago
  Why does it matter?
divbzero 7y ago
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?
AlexCoventry 7y ago
Isn't a specificity of 92% unacceptable for a test like this?
dan_quixote 7y ago
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.
jrockway 7y ago
Very interesting. I am kind of curious as to whether or not I had COVID-19, and would be willing to pay $20 to find out. (The backstory is... I went to this party in early February. My friends were sick and they said that there was a really strange cold going around their office; everyone was sick, and the symptoms were different from their usual colds. Everyone there travels like crazy. About 3 days later, I got sick, and indeed... it was very unlike my usual colds and very much like the symptoms associated with COVID-19. It didn't raise any alarm to me at the time, but with a month and a half of knowledge later, it sure seems suspicious to me.)
geuis 7y ago
I think its irresponsible to leave this post undead.
tim333 7y ago
They've had these things in china since early feb https://www.livemint.com/news/world/coronavirus-live-update-death-toll-crosses-800-one-in-20-people-in-wuhan-is-infected-11581217643145.html https://www.livemint.com/news/world/coronavirus-live-update-... and you can buy similar on alibaba for 1$ 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.

302 points by ck2 7y ago

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.

joezydeco 7y ago

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-novel-coronavirus-dual-igg-igm-rapid-test https://www.pblabs.com/products/pinnacle-biolabs-covid-19-no... Mine arrived in the mail this morning.

carlhu 7y ago
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-medical-devices/emergency-use-authorizations https://www.fda.gov/medical-devices/emergency-situations-med....
- joezydeco 7y ago
  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.
WoodenChair 7y ago
Are there any reviews? Any third party verification? How do I know that this is legitimate? These are sincere questions, I'm not just being difficult.
- scrollaway 7y ago
  Isn't FDA clearance the very definition of "third party verification"?
  - imperio59 7y ago
    Looks like they got a CE seal on Feb 20, per their website. That's something at least.
    - WoodenChair 7y ago
      Can we trust their website? Is it on another website somewhere?
  - WoodenChair 7y ago
    Is it on the FDA website somewhere?
aqme28 7y ago
Did you buy it for some sort of industry use, or as a regular consumer for personal testing?
- joezydeco 7y ago
  Personal use. I ordered it weeks ago purely as a hypothetical. If I was home sick with a flu, was it seasonal or was it nCov? This was before all the lockdowns started. I also bought a fingertip pulse oximeter for the same reason. I’m surprised those haven’t been hoarded...yet.
amvalo 7y ago
Seems to be a scam. If you look up their FDA registration number nothing shows up.
- joezydeco 7y ago
  I’ve used some of their other home testing kits before, like their colon cancer screening kit. Detects globin at 50 ng/mL and is board approved by gastroenterologists. The company isn’t a scam.
  - amvalo 7y ago
    Yeah, after digging into it more I saw that. Doesn't explain the missing FDA number though which is quite sketchy.
    - joezydeco 7y ago
      Their number is listed in the info brochure. https://cdn.shopify.com/s/files/1/1010/0544/files/COVID19BrochureFront.pdf?v=1583766247 https://cdn.shopify.com/s/files/1/1010/0544/files/COVID19Bro...
      - amvalo 7y ago
        Yeah, and it's not listed... in the actual FDA database.
        joezydeco 7y ago
        Found it in 3 clicks. Maybe it's been recently updated? https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?rid=172941 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.c... https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=651998&lpcd=QJR https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.c...
        amvalo 7y ago
romski 7y ago
Link already removed :-(

jspash 7y ago

From the website: "This test has not been reviewed by the FDA" So which is it?

ck2 7y ago
Website has not been updated. There's been news and press releases. https://www.biospace.com/article/releases/20-20-bioresponse-to-launch-rapid-coronavirus-test-kits-in-u-s-following-green-light-from-fda/ https://www.biospace.com/article/releases/20-20-bioresponse-... 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 7y ago
  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.

baybal2 7y ago

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.

gopalv 7y ago
> That's an antibody test, not an RNA test. Yes, this is an exposure test - which works okay for a completely novel virus like this one. The real question is whether this has a drop-off factor for immunity for instance (i.e non-infectious herd immune) or if it can differentiate between exposure and carrier for the disease. It might be useful right now, but it will get less useful as the months go by. For instance, the QuantiFeron test for TB tests me as positive because my white blood cells take TB very seriously (or so it looks like).
whateveracct 7y ago
Surely still important progress & a big deal though, right?
- lisper 7y ago
  This will make it easier to tell if a symptomatic person has COVID or something else. But it won't help with early detection, which is what is most urgently needed.
  - noelsusman 7y ago
    We needed early detection weeks ago. That ship has sailed. At this point a test like this is probably more urgent. The lead time on getting tests for patients showing up to the hospital (i.e. they have symptoms) will make a massive difference in how much PPE the hospital goes through.
  - dogma1138 7y ago
    Early detection is utterly irrelevant at this point it’s endemic at most places now.

deleted 7y ago

[deleted]

ars 7y ago

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 7y ago
What if you're asymptomatic?
- ElijahLynn 7y ago
  Should work if someone is asymptomatic because it tests the antibodies that our bodies produce after having gotten SARS-CoV-19.
- ars 7y ago
  According to the logo on this graph, it only works 7 days after symptoms appear: https://coronachecktest.com/wp-content/uploads/2020/03/antibody-chart-cropped-1.jpg https://coronachecktest.com/wp-content/uploads/2020/03/antib...
gpm 7y ago
I'm curious what you're basing the 1 week off of? As far as I can tell the company isn't reporting any data about how long it takes, but they think that it is likely to be similar to SARS per their manuscript: https://coronachecktest.com/wp-content/uploads/2020/03/Development-and-Clinical-Application.pdf https://coronachecktest.com/wp-content/uploads/2020/03/Devel... > It was reported that after SARS infection, IgM antibody could be detected in patient blood after 3-6 days and IgG could be detected after 8 days. Since COVID-19 belongs to the same large family of viruses as those that cause the MERS and SARS outbreak, we assume its antibody generation process is similar, and detection of the IgG and IgM antibody against SARS-CoV-2 will be an indication of infection.
- ars 7y ago
  > I'm curious what you're basing the 1 week off of? There is a graph at the bottom of their homepage: https://coronachecktest.com/wp-content/uploads/2020/03/antibody-chart-cropped-1.jpg https://coronachecktest.com/wp-content/uploads/2020/03/antib... The first red dot is at the 7 day mark.

ElijahLynn 7y ago

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

ck2 7y ago
https://www.biospace.com/article/releases/20-20-bioresponse-to-launch-rapid-coronavirus-test-kits-in-u-s-following-green-light-from-fda/ https://www.biospace.com/article/releases/20-20-bioresponse-...

jupp0r 7y ago

> 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 7y ago
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?
- cma 7y ago
  It is probably useful for getting population statistics and directing higher level actions, or even at some point overquarantining people based on positives and false positives, but people that get a false sense of security are a risk. There was an article about a village leader who tested negative and had 200 villagers come to congratulate him, then he tested positive on a subsequent test.
- joshmaker 7y ago
  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/coronavirus-test-kits-south-korea-us/2020/03/13/007f14fc-64a1-11ea-8a8e-5c5336b32760_story.html https://www.washingtonpost.com/world/asia_pacific/coronaviru... > 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-testing-world-countries-cities-states.html https://www.nytimes.com/2020/03/20/world/europe/coronavirus-...
  - 7y ago

dktoao 7y ago

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.

chapium 7y ago
Its so easy to take in news we want to hear. You are right, this needs better sources.
ck2 7y ago
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 7y ago
  Theranos

kragen 7y ago

"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 7y ago
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 7y ago
  I think they are referring to the (mis)spelling of 'qualatative.'
  - jacobsenscott 7y ago
    There are many mispelingz on there cite. It duz nut look gud 4 them atall.

nsxwolf 7y ago

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

ck2 7y ago
-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.

jariel 7y ago

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 7y ago
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 7y ago
  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 7y ago
    >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 7y ago
      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.

CriticalCathed 7y ago

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 7y ago
> 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 7y ago
  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

chrisweekly 7y ago

"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...

absherwin 7y ago

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-Science-Report-Diagnostics-13-Mar.pdf https://sph.nus.edu.sg/wp-content/uploads/2020/03/COVID-19-S... 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

BurningFrog 7y ago
A test for who is immune seems very important a few months down the road!
- munk-a 7y ago
  Oh that's easy - just find one of those Floridian beach goers. Anyone still fine in three weeks is immune.
gridspy 7y ago
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 7y ago
  Slightly off topic question: do people who have been infected with those varieties have any sort of immunity against covid-19?

deleted 7y ago

[deleted]

classics2 7y ago

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 7y ago
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 7y ago
  I’m surprised authorize.net hasn’t slammed the door on thier merchant account yet. Massive chargeback risk here.
ck2 7y ago
https://www.businesswire.com/news/home/20200318005814/en/ https://www.businesswire.com/news/home/20200318005814/en/

yread 7y ago

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/10.1101/2020.03.18.20038059v1 https://www.medrxiv.org/content/10.1101/2020.03.18.20038059v...

tbodt 7y ago

"For profesional use only"

orblivion 7y ago

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 7y ago
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 7y ago
  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 7y ago
    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 7y ago
      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.

ChicagoDave 7y ago

Who owns the rights and are they making any profit?

forgotmyhnacc 7y ago
Why does it matter?

divbzero 7y ago

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?

AlexCoventry 7y ago

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

dan_quixote 7y ago

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.

jrockway 7y ago

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.)

geuis 7y ago

I think its irresponsible to leave this post undead.

tim333 7y ago

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