No expert but if it was a scam wouldn't they want to sell directly to end users?
Probably violating the master merchant agreement of every card network by selling it at this point, so proceed with caution.
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:
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
I’m hoping this is true, since it suggests new parents are mostly OK too.
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.
"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"
If true, we might rush to get everyone cold and then be immune to coronavirus.
"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 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.
Even you could change that, just cost would make this approach very useful.
I think my high school stats class told me not to trust studies where N < 30.
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'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?
If you're asymptomatic, would it also be positive?
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.
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.
5. Identify whether there are riskier subpopulations or if everybody is on the same risk level.
My personal opinion is absolutely. But I'm 99% certain a vocal minority will spoil it for us.
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.
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.
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 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?
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.
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.
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.
You sure that's not hyperbole? If you believe that, you need to turn off the news.
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.
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).
Not really sure how you read that as somehow advocating immune compromised people do not need to take this seriously.
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.
It might be necessary at some point, however.
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.
>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.
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?
The period of immunity following infections varies, and this virus is not well understood.
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.
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).
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.
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.
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'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.
 Antivirals are a crap shoot but serum works hands down.
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.
So this is much better than any RNA test to assess the progression of the disease through the population.
Mine arrived in the mail this morning.
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.
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.
You said your test kit arrived already? What does it look like?
This seems like it could provide a false sense of security to many if used widely by the general population.
† (well, precisely 0.979 out of every 82300.979 people, but the difference is not significant in this context)
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.
>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.
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.
> 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.
> 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
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.
If the claim cannot be verified, could OP or a moderator please correct the title?
(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.)
So which is it?
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 $1 a hit would be better, I thought there were machines in place that could do this and just needed reprogramming but that doesn't seem to have ever materialized and was just another empty promise in the moment.
> CoronaCheck was evaluated in China using 760 clinical samples. In this cohort, 286 samples were confirmed positive. Our manufacturers report a sensitivity of 97.2% and specificity of 92%.
I wonder how this compared to other tests.
and you can buy similar on alibaba for 1$ 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.
It might help differentiate COVID from Flu if someone is sick, but it's not great for screening otherwise healthy people.
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.
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.
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.
How long immunity lasts after recovery is still an unknown. Maybe for life, maybe for weeks. Repeated tests over time will tell.
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.
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.
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.
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.
"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.
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.