[HN Gopher] FDA just cleared a $20 Covid-19 antibody test
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FDA just cleared a $20 Covid-19 antibody test
Author : ck2
Score : 172 points
Date : 2020-03-20 21:41 UTC (1 hours ago)
(HTM) web link (coronachecktest.com)
(TXT) w3m dump (coronachecktest.com)
| [deleted]
| ars wrote:
| 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 wrote:
| What if you're asymptomatic?
| ElijahLynn wrote:
| Should work if someone is asymptomatic because it tests the
| antibodies that our bodies produce after having gotten SARS-
| CoV-19.
| gpm wrote:
| 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/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.
| Animats wrote:
| 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.
| [deleted]
| ElijahLynn wrote:
| It says > "This test has not been reviewed by the FDA."
| classics2 wrote:
| 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.
| joezydeco wrote:
| 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...
|
| Mine arrived in the mail this morning.
| carlhu wrote:
| 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....
| joezydeco wrote:
| 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 wrote:
| 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.
| jupp0r wrote:
| > 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.
| mikeha wrote:
| And also this.
|
| >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.
| chrisshroba wrote:
| So other people don't have to google like I did: this means
| this test should correctly diagnose 97.9% of people with the
| disease, and should correctly diagnose (i.e. give a negative
| result to) 91.77% of people without the disease.
| product50 wrote:
| 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 wrote:
| 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.
| ..
|
| > 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-.
| ..
| vscientist wrote:
| jupp0r is correct; this is a real problem for a disease that
| is so contagious.
|
| Lets say the covid-19 (real) prevalence is 0.1% in the US
| now. That means 10k infected people for every 10 Million
| people. If 10M take the test, 97.90 % sensitivity means, of
| the 10k (true) infected people, 210 will show up as negative.
| If these people go out and "mingle", there is potential for
| the infection to pick up again.
| cma wrote:
| It is probably useful for getting population statistics and
| directing higher level actions, or even 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.
| sheeshkebab wrote:
| Nothing is life is certain
| kragen wrote:
| It also means that, if that number is correct, 8.23% of not-
| yet-infected people will test positive. At a time when only
| 0.01% of people are infected, that means that 8.2301% of people
| will test positive, and of those people, on average one person+
| of every 82301 people will have the infection; the other 82300
| are all false positives. They'll need to improve that for this
| to be useful, since at the time 1% of the population is
| infected, you're already suffering the worst catastrophe in a
| century.
|
| + (well, precisely 0.979 out of every 82300.979 people, but the
| difference is not significant in this context)
| yread wrote:
| 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...
| jspash wrote:
| From the website: "This test has not been reviewed by the FDA"
|
| So which is it?
| ck2 wrote:
| Website has not been updated. There's been news and press
| releases.
|
| 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 wrote:
| 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.
| dktoao wrote:
| 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 wrote:
| Its so easy to take in news we want to hear. You are right,
| this needs better sources.
| kragen wrote:
| "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 wrote:
| 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 wrote:
| I think they are referring to the (mis)spelling of
| 'qualatative.'
| nsxwolf wrote:
| Isn't "cleared" status the same thing that those laser hair
| regrowth hats get?
| ck2 wrote:
| -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 wrote:
| 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 wrote:
| 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.
| CriticalCathed wrote:
| 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.
| chrisweekly wrote:
| "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 wrote:
| 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
|
| 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...
|
| The paper on which this test is based:
| https://onlinelibrary.wiley.com/doi/pdf/10.1002/jmv.25727
| gridspy wrote:
| 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 wrote:
| Slightly off topic question: are people who have been
| infected with those varieties have any sort of immunity
| against covid-19?
| BurningFrog wrote:
| A test for who is immune seems _very_ important a few months
| down the road!
| munk-a wrote:
| Oh that's easy - just find one of those Floridian beach
| goers. Anyone still fine in three weeks is immune.
| supdatecron wrote:
| > will only be positive days after the onset of symptoms.
|
| If you're asymptomatic, would it also be positive?
| dogma1138 wrote:
| Yes since it's an antibody test.
| pfranz wrote:
| > 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
|
| I've been looking forward to seeing this kind of test just for
| this reason so we can whitelist people. But since a large
| percentage of people don't have symptoms how can you tell if
| you're still shedding the virus?
| nostromo wrote:
| Question: would it show who has antibodies from previous
| exposure, long after they've been exposed?
|
| It'd be great for people to know if they have antibodies and
| can return to work.
| baybal2 wrote:
| 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.
| cactus2093 wrote:
| I don't know how much precedent there is for this type of
| testing (have we used similar things for Ebola or SARS or
| measles or anything else?).
|
| I've read that this will be useful in broad studies to track
| how widely the disease might have spread without being
| diagnosed. But will this type of antibody test eventually be
| available for any doctor to order for a patient? I'm just
| getting over a fairly mild but persistent chest cold which also
| had me with a slight fever last week, and would really like to
| know if it is/was covid-19 or not. Last week when I still had
| the worst of the symptoms, my doctor said I didn't meet enough
| of the criteria to be tested.
| whateveracct wrote:
| Surely still important progress & a big deal though, right?
| lisper wrote:
| 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 wrote:
| 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.
| mantas wrote:
| Big chance of getting false-positive. People will think
| they're clear and won't distance themselves from vulnerable.
| While they may be carriers.
| Amygaz wrote:
| I don't know why you are being down voted. The risk is for
| false-negative, but you are right that people might think
| this is going to clear them.
|
| Even the manufacturer/supplier warns that: "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."
|
| They also indicate: "The sensitivity is 97.90 %, the
| specificity is 91.77%."
|
| But when you read the technical document you realize that
| this was for a subset of patient. The real numbers are
| 88.7% and 90.6% respectively, and again these are for
| severe cases.
| JshWright wrote:
| That would not be the effect of a false positive.
|
| In any case, these tests would be used to confirm or rule
| out SARS-CoV-2 as the cause of someone's symptoms. They
| wouldn't be used for routine screening of asymptomatic
| people.
| hackcasual wrote:
| This also requires a blood sample, as opposed to a swab.
| baybal2 wrote:
| That's actually better, some competent people said, because
| the chance of contact with virus carrying bodily fluids is
| eliminated
| hackcasual wrote:
| Except people generally don't like needle sticks.
| gopalv wrote:
| > 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).
| 1996 wrote:
| It will also detect recent infection after the virus has been
| wiped out but the antibodies remain.
|
| So this is much better than any RNA test to assess the
| progression of the disease through the population.
| KerrickStaley wrote:
| From my understanding, this should still detect the virus in
| individuals with mild or no symptoms, correct? Because those
| individuals do have an immune response.
|
| But what you're saying is that RNA tests will have better
| recall during the initial stages of infection when the virus is
| multiplying in someone's body and that person doesn't yet have
| an immune response?
| Gibbon1 wrote:
| That I understand is totally correct.
| adrr wrote:
| It's important to test the public to see the penetration into
| the population. People who test positive should get an RNA test
| to determine if infected. People who are not infected become
| valuable assets to keep logistics and supply chain up and work
| front line tasks as they have little risk of getting infected.
| This group people can return back to normal life and don't need
| to be lockdown.
| CreepGin wrote:
| I can't help but ask... How much risk is "little risk" here?
| Can they still contribute to the spread? And what percentage
| of population can fall into this group?
| codyb wrote:
| I think if you test positive with an antibody test but not
| an rna test it means your immune system has the ability to
| fight it off from a previous infection but the virus isn't
| currently multiplying inside you.
| devonbleak wrote:
| If you're testing positive for antibodies and negative for
| the virus RNA itself it means your immune system has been
| exposed and recovered. This is also what you'd expect to
| see in someone that has been vaccinated. They would not be
| contagious at that point because the virus is not present.
| This is not the same as someone that gets infected but is
| asymptomatic - they would still test positive for RNA.
|
| The percentage of the population that would naturally fall
| into this group would likely be very small given this is a
| novel virus so pretty much nobody's immune system had been
| exposed prior to a few months ago, and we're seeing pretty
| massive infection rates globally.
| maxerickson wrote:
| We don't know.
|
| The period of immunity following infections varies, and
| this virus is not well understood.
| Gibbon1 wrote:
| I think it's likely useful for mild cases and for detecting
| people previously infected. People that recovered can be put to
| work in hazardous places. And can donate plasma to make
| serum[1] for treating sick people.
|
| [1] Antivirals are a crap shoot but serum works hands down.
| frandroid wrote:
| How about a source for that [1]
| hackcasual wrote:
| https://www.jci.org/articles/view/138003
|
| It's far to early to call it a slam dunk for nCov-2, but it
| is a treatment already used for rabies and hepatitis.
| product50 wrote:
| Are you a doctor? If not, why are you commenting on things you
| have no expertise on?
| erentz wrote:
| 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.
| jimmcslim wrote:
| > I don't know if this is something that anyone official is
| talking about yet, but it seems like it should be.
|
| I agree. I think this will greatly help with people's mental
| state, etc, plus they can help family and friends who are
| under quarantine. The question of how long immunity lasts, is
| it effective, etc is still a bit open. Also, how in a Western
| democracy do we distinguish (from the point of view of law
| enforcement personnel) between those who are immune and those
| who are breaking quarantine?
| yzmtf2008 wrote:
| Having antibody doesn't mean you can't spread the virus. For
| example, antibody tests are often used to diagnose HIV, but
| testing positive for HIV antibody (i.e. you are infected)
| doesn't mean that life will be normal.
| throwaway2048 wrote:
| There is evidence that people can become re-infected, so
| antibodies aren't enough.
| xsmasher wrote:
| Citation?
|
| I saw the one story about people "testing positive again"
| but that seemed to be a testing abnormality, not people
| getting sick a second time.
| crispyporkbites wrote:
| Citation? IIRC all of the examples were either false
| positive re-tests or atypical patients (i.e. with some
| immune issue that only supressed the virus when they tested
| negative)
| erentz wrote:
| 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.
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(page generated 2020-03-20 23:00 UTC)