It says > "This test has not been reviewed by the FDA."
FDA just cleared a $20 Covid-19 antibody test
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Re: FDA just cleared a $20 Covid-19 antibody test
#22Keep 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.
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.
Re: FDA just cleared a $20 Covid-19 antibody test
#23They 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.
Re: FDA just cleared a $20 Covid-19 antibody test
#24> 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.
Re: FDA just cleared a $20 Covid-19 antibody test
#25That'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.
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?
Re: FDA just cleared a $20 Covid-19 antibody test
#26Ummm, 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.
Re: FDA just cleared a $20 Covid-19 antibody test
#27Earlier quoted context omitted.
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.
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.
Re: FDA just cleared a $20 Covid-19 antibody test
#28"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.
Re: FDA just cleared a $20 Covid-19 antibody test
#29That'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.
Are you a doctor? If not, why are you commenting on things you have no expertise on?
Re: FDA just cleared a $20 Covid-19 antibody test
#30Isn't "cleared" status the same thing that those laser hair regrowth hats get?