FDA just cleared a $20 Covid-19 antibody test | Hacker News Reader

FDA just cleared a $20 Covid-19 antibody test

coronachecktest.com

302 pointsck2181 comments

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.

Its so easy to take in news we want to hear. You are right, this needs better sources.

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?

Theranos

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.

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."

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

https://www.businesswire.com/news/home/20200318005814/en/

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

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."

Those are the most common corona viruses strains that cause symptoms of the common cold (which itself is caused by something like ~200 known different viruses, the most prevelant being rhinoviruses). I was under the impression many people already had these antibodies

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

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.

The theory I've heard: Children mostly rely on their innate immune system compared to adults, where the adaptive immune system is more fully developed. In elderly people, the immune response of both systems is slower/weaker.

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.

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

No immunity. but they develop antibodies. More info here:

"FDA is working on treatment of coronavirus with blood from recovered patients"

"The method — essentially harvesting virus-fighting antibodies from the blood of previously infected patients — dates back more than a century"

https://www.nbcnews.com/health/health-news/fda-working-treat...

Potentially.

If true, we might rush to get everyone cold and then be immune to coronavirus.

From the last paragraph before conclusion of their article:

"Certainly, this test cannot confirm virus presence, only provide evidence of recent infection, but it provides an important immunological evidence for physicians to make the correct diagnosis along with other tests and to start treatment of patients. In addition, possible cross-reactivity with other coronaviruses and flu viruses were not studied, and the change level of antibody was not compared in the different stages of SARS-CoV-2 infection."

This preprint explores, in part, cross-reactivity for a similar test and found it to negligible: https://www.medrxiv.org/content/10.1101/2020.03.17.20037713v...

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

This isn't really what your Twitter link says. That links says: "Both IgM & IgG (those are two different kinds of antibodies, with IgA being a third) were low or undetectable at day 0, but increased by day 5 in nearly all patients (N=16)"

-- Reports strongly indicate there are many infected people who are asymptomatic after five days.

Which is to say, this test could be extremely useful if applied widely and systematically to many people; food service workers, health care workers and so-forth.

Currently the virus test has a week turn around time. So both tests effectively find people with a week's exposure.

Turn around time is mostly due to shipping samples to outside labs, in addition to outside labs lacking automation.

But that doesn't change the current situation.

Even you could change that, just cost would make this approach very useful.

Does "N=16" mean they've approved this test after such limited testing?

I think my high school stats class told me not to trust studies where N < 30.

I think the acceptable value for N depends on the size of the effect being studied.

For example if it’s a massive effect, maybe 10 people is sufficient, but if it’s tiny enough to get swallowed up in statistical noise until you have 1000, then you need N >= 1000

I would be told off if I coded with magic global variables and is why I find math and bio frustrating. Care to explain the purpose of N?

Its the number of people they used to test.

Is this test able to detect that someone is infected before they start to infect others?

No. This test tells us that you had covid-19 in the past and recovered from it.

> 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?

I assume if you test positive for the antibody and N days later test negative for the virus, you’d be in the clear to be whitelisted.

> will only be positive days after the onset of symptoms.

If you're asymptomatic, would it also be positive?

Yes since it’s an antibody test.

Hold on. Has it been confirmed that recovered people do in fact develop immunity?

It's ok to take that on faith. If you recover from the virus, it's because your immune system knows how to kill the virus. We don't know of any immune system interactions that don't work that way.

There's a chance that immunity is short-lived, or that there are multiple strains of the virus which do not produce equivalent antibodies, but 100% of scientists will believe you develop immunity of some sort.

> We don't know of any immune system interactions that don't work that way.

Unfortunately not the case. https://en.wikipedia.org/wiki/Antibody-dependent_enhancement

But the good news is that we don't have any knowledge of coronaviruses that get worse the second time around because of ADE.

Isn't that a case of having multiple strains of the virus, where recovering from one strain still provides immunity to that strain? The gimmick here is that it decreases resistance to the other strain, possibly after some time.

I was hearing some doctors saying on the radio that any flu immunity is short lived, this is why we need to have the anti-flu vaccinations every year, that cover the typical/usual strains. If immunization lasted forever there wouldn't be a need for annual vaccination.

rhesus monkeys do - https://www.biorxiv.org/content/10.1101/2020.03.13.990226v1....

I think its almost certain that if it were possible to be re-infected (at least in short timescales), it would have happened by now, somewhere.

There have been reports, but it’s not to my knowledge clear whether the people who’ve tested positive after being considered recovered were experiencing something else, like a false positive before/after, or weren’t in fact fully recovered.

Running theories so far are that those were relapses, not reinfections.

4. Measuring what share of people actually develops the disease so we can model forward the spread of the virus.

5. Identify whether there are riskier subpopulations or if everybody is on the same risk level.

I'm interested in the frontline response here as if you already have immunity that person can serve in "risky" positions like working at airports, etc.

Serious question: can an employer discriminate based on immunity status?

My personal opinion is absolutely. But I'm 99% certain a vocal minority will spoil it for us.

I am pretty sure there is a list of things that employers (in the US) can't discriminate on, and immunity to Coronavirus isn't one of them.

I think it will ultimately be in the hands of workers to decide whether or not they want to do the job. Maybe I'm immune to Coronavirus so I should work in a pharmacy... but I get paid 10x as much writing software, so I'm probably going to do that instead.

What if you’re immunocompromised with a hereditary illness? If there’s reasonable grounds it makes sense but reasonable and what employers will try and get away with are two different things.

A test for who is immune seems very important a few months down the road!

Oh that's easy - just find one of those Floridian beach goers. Anyone still fine in three weeks is immune.

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.

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.

> 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?

Perhaps requiring people to sew a red-colored letter to their clothing?

>are breaking quarantine

Happened today. Police can stopped outside our building Two policemen came out. One was holding a notepad+pen, and one was holding his cellphone. One was reading phone numbers and keeping notes, the other was dialing numbers, asking people to come out to their balconies so they see they are self-isolated and staying at their homes. Very simple and efficient way to see who stays and who runs.

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.

That’s true. Though you could still buffer it with a “must be positive for N weeks” rule.

Also, while there would be concern about a positive but still shedding person coming into contact with one who hasn’t contracted it, there’d be no issue with them hanging out/working/etc with others who are positive.

Having antibodies and waiting 14 days to be safe will be good enough to be whitelisted.

Right now the only way to be whitelisted is having had a test done while being ill, but asymptomatic cases are unlikely to ever get tested.

> Those people can then start to go back to regular life (what’s left of it)

You sure that's not hyperbole? If you believe that, you need to turn off the news.

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

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.

> 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.

uh, how? Perhaps this is tangential, but it's important that anyone who is immunocompromised takes this seriously. Don't just think you'll be ok with a bit of luck. If you are immunocompromised your immune response is by definition weak and we have no working therapeutics.

Yeah, yeah, I know there are 2 promising ones but its not really clear. The Gilead one is fairly legit, but the protocol used to compare Chloroquine for covid is fucking bullshit. They compared people across hospitals, way too many things different, you can't actually draw any valid scientific conclusion - it's purely anecdotal (as thankfully Fauci made more clear to the public today).

I don’t think you read my comment in the context of what it was replying too. It was a response to someone saying people can get reinfected. The reports of this appears not to the case for the reasons I and others explained (false positives/negatives). I speculate it might possibly happen for real though in the case of immune compromised people who are lucky enough to survive, but due to being immune compromised do not mount a proper adaptive response. Thus develop no antibodies and and thus are able to be reinfected. Obviously that would be rare. (But so are these case reports that are driving these rumors of “reinfection” overall.)

Not really sure how you read that as somehow advocating immune compromised people do not need to take this seriously.

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.

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?

The problem is that with such a high rate of hospitalization or even death, even for young healthy adults, that’s a risky approach.

It might be necessary at some point, however.

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)

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.

https://www.latimes.com/world-nation/story/2020-03-13/china-...

Time will tell, but from that article:

>Scientists in and outside China agree that reinfection is a highly unlikely explanation for the patients who retest positive. They say testing errors are more likely to blame — either false negatives that resulted in patients being discharged too early, or false positives when they retested and were taken back into hospital.

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?

That I understand is totally correct.

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.

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?

We don't know.

The period of immunity following infections varies, and this virus is not well understood.

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.

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.

> 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).

Surely still important progress & a big deal though, right?

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.

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.

Early detection is utterly irrelevant at this point it’s endemic at most places now.

Exhaustive testing and selective isolation would be better than lockdowns, even if the virus is endemic. Testing is the bottleneck.

Testing is a bottleneck which is why you need as many testing venues as possible including mail-in at home tests for the more rural areas.

The US isn’t South Korea it’s population density is drastically different as well as its geographical scale which makes viral protein and RNA tests much harder to conduct.

At this point social distancing and a multi phase testing plan will be required which will undoubtedly include field AB testing to reduce the load on testing facilities.

AB testing also provides additional valuable data points including a more accurate infection figures since it can come out positive as long as the antibodies remain in your system.

Big chance of getting false-positive. People will think they're clear and won't distance themselves from vulnerable. While they may be carriers.

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.

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.

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.

They are called serology tests and widely available for other viruses and bacteria. Its just that Covid-19 is such a new thing that the tests are just being developed.

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.

How about a source for that [1]

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.

One of my teachers in the 70's came down with HepA. Health department required all of us to get a immune globulin shot before returning to school.

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.

This also requires a blood sample, as opposed to a swab.

That's actually better, some competent people said, because the chance of contact with virus carrying bodily fluids is eliminated

Except people generally don't like needle sticks.

Trust me they like swabs less they are by far more uncomfortable than a prick.

Are you a doctor? If not, why are you commenting on things you have no expertise on?

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.

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....

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.

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.

Isn't FDA clearance the very definition of "third party verification"?

Looks like they got a CE seal on Feb 20, per their website. That's something at least.

Can we trust their website? Is it on another website somewhere?

Is it on the FDA website somewhere?

Did you buy it for some sort of industry use, or as a regular consumer for personal testing?

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.

Seems to be a scam. If you look up their FDA registration number nothing shows up.

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.

Yeah, after digging into it more I saw that. Doesn't explain the missing FDA number though which is quite sketchy.

Their number is listed in the info brochure.

https://cdn.shopify.com/s/files/1/1010/0544/files/COVID19Bro...

Yeah, and it's not listed... in the actual FDA database.

Found it in 3 clicks. Maybe it's been recently updated?

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.c...

"Page Last Updated: 03/23/2020"

Strange indeed.

You said your test kit arrived already? What does it look like?

Well, pretty much like the picture. Package insert is the same. Not going to unwrap the LFA device unless it's really necessary.

Link already removed :-(

> 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.

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)

Yeah, that's the Base Rate Fallacy https://en.wikipedia.org/wiki/Base_rate_fallacy.

I'm a little confused at your calculations.

With a population size of 1000 and with 0.01% of the population infected (i.e. 1 individual) with this test we'd get 82 false positives and 0.979 true positives.

For every true positive result in your population, you'll have 8 false positive results and 0,021 false negatives.

0.01% of 1000 is 0.1 people, not 1 people, and 82÷1 is 82 and not 8, but you're right that my calculations weren't correct either. You'd get 82 false positives and 0.1 (or 0.0979) true positives, so for every true positive result, you have 820 false positives, not 82300 as I said.

RT-PCR tests can be way worse than this.

https://i1.wp.com/emcrit.org/wp-content/uploads/2020/03/perf...

https://emcrit.org/ibcc/COVID19/

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.

I feel like false positives are less damaging than false negatives at this point. Unnecessarily putting people into self quarantine is not the worst, as opposed to giving false security to potentially infectious people.

But this is an antibody test, for people who have already recovered from the virus. False positives in this case are precisely what would give people a false sense of security.

Antibodies are present as soon as there are symptoms or soon after, so these tests are designed to be taken by sick people.

Not so great if people are using to test to see if they're "immune"

Testing should perhaps not be done at home, at all.

True positives could be sent for PCR testing to confirm whether they are infected or already cleared.

Negatives that show symptoms could likewise be sent for PCR testing.

This way, you'd massively reduce the strain on PCR testing resources.

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.

Nothing is life is certain

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?

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-...

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.

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.

Worse, if 10M take the test, 97.90% sensitivity means, 210 000 will show up as positive. (Only 10 000 actually are.)

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.

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?

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.)

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...

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

So which is it?

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.

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.

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.

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.

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.

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.

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.

There's absolutely no evidence to suggest that happened.

Suggest what happened

They've had these things in china since early feb 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.

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.

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.

> 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/antib...

The first red dot is at the 7 day mark.

What if you're asymptomatic?

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

According to the logo on this graph, it only works 7 days after symptoms appear: https://coronachecktest.com/wp-content/uploads/2020/03/antib...

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.

> 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?

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

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.

"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...

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.

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.

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.

>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.

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.

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

-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.

"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.

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.

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

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

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.

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

https://www.biospace.com/article/releases/20-20-bioresponse-...

I think its irresponsible to leave this post undead.

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

Who owns the rights and are they making any profit?

Why does it matter?

"For profesional use only"

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