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FDA just cleared a $20 Covid-19 antibody test

coronachecktest.com

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Re: FDA just cleared a $20 Covid-19 antibody test

#11

Post by KerrickStaley »

baybal2 wrote: post #5

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.

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?

Re: FDA just cleared a $20 Covid-19 antibody test

#12

Post by lisper »

whateveracct wrote: post #8
baybal2 wrote: post #5

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.

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.

Re: FDA just cleared a $20 Covid-19 antibody test

#13

Post by mantas »

whateveracct wrote: post #8
baybal2 wrote: post #5

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.

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

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

Re: FDA just cleared a $20 Covid-19 antibody test

#14

Post by carlhu »

joezydeco wrote: post #2

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....

Re: FDA just cleared a $20 Covid-19 antibody test

#16

Post by adrr »

baybal2 wrote: post #5

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.

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.

Re: FDA just cleared a $20 Covid-19 antibody test

#17

Post by baybal2 »

hackcasual wrote: post #9
baybal2 wrote: post #5

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.

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

Re: FDA just cleared a $20 Covid-19 antibody test

#18

Post by ilyagr »

ck2 wrote: post #4
jspash wrote: post #3

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…

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.

Re: FDA just cleared a $20 Covid-19 antibody test

#19

Post by Gibbon1 »

baybal2 wrote: post #5

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.

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.

Re: FDA just cleared a $20 Covid-19 antibody test

#20

Post by Gibbon1 »

KerrickStaley wrote: post #11
baybal2 wrote: post #5

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.

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.
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