LabCorp's at-home COVID-19 Test Kit is the First To Be Authorized by the FDA (techcrunch.com) 36
LabCorp's at-home COVID-19 test, which is called 'Pixel,' has received the first Emergency Use Authorization (EUA) for such a test missed by the U.S. Food and Drug Administration (FDA). From a report: The test is an at-home collection kit, which provides sample collection materials including a nasal swab to the user, who then uses the included shipping package to return the sample to a lab for testing. Until now, the FDA has not authorized any at-home testing or sample collection kits for use, and in fact clarified its guidelines to specifically note that their use was not authorized under its guidelines when a number of startup companies debuted similar products for at-home collection and round-trip testing with labs already certified to run molecular RT-PCR tests to detect the presence of COVID-19. The FDA notes that only LabCorp's COVID-19 RT-PCR test has received this authorization, and that it still requires any such test to have an EUA before they can being offering services, whether or not the test is administered at home with the help of guidance from an authorized medical professional via telemedicine. Some labs facilitating at home serology tests using an exception in the FDA guidelines, but these are not viewed by the agency as tests that can confirm a case of COVID-19.
Love to see the False Negative Rate (Score:3)
I'd put good money on 99% of people not realizing just how far back you gotta shove that swab to collect a proper sample.
Re:Love to see the False Negative Rate (Score:4, Funny)
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Studies have found false negative rates as high as 29% with professionally administered test, and I wouldn't be surprised if getting a good sample isn't a big part of that. That's why it's so important for drug trials to be blind.
COVID-19 can also be detected in stool samples, so maybe that would be better.
I think we also need a blood antigen test to identify people who have had COVID-19 but are no longer sick.
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Those are out already, there's multitude of different ones by different companies. But they haven't been validated, so who knows how many false positives or false negatives they have.
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> I think we also need a blood antigen test to identify people who have had COVID-19 but are no longer sick.
The sensitivity and specificity both have to be really high for this to work. The newest commercial test to come online still tests positive for five different coronaviruses.
This could work:
1) test negative for those five
2) get CoVID-19, confirmed with accurate PCR
3) test positive for antibodies, at a titre proven to be effective but not cause ADE.
Then those people could be reasonably judged to ha
New info: You don't have to go deep (Score:2)
The FDA updated their guidelines three weeks ago.
FDA now says "for symptomatic patients, nasal swabs could be used that access just the front of the nose rather than the depth of the nasal cavity."
Here is *part* of the story:
https://www.knkx.org/post/swab... [knkx.org]
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Take this thing out of the case and stick it up your nose. Don't worry; it's self guiding. Just shove real hard. When you hear the crunch, you're there.
Nobody's infected, open up the country! (Score:2)
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I'd mod you up if only I could. If this was a sputum test, then maybe. Nasal swab - no. Even the professionals don't always get it right. Not even to mention the lack of the clinical analysis. And the point of testing should be to determine whether to start contact tracing or not (any positive case, even if mild) or how to treat a more severe case (positive or negative). I feel the results might be used completely incorrectly in the case of at-home testing.
Do you have to stick the thing up your nose? (Score:2)
Cause if you do, I'm out.
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You are in luck! It does not go "up" the nose. It goes straight back. Unfortunately, it goes back about 5 inches.
I think most people here are in on the joke. In case anyone isn't, the swabbing that needs to be done is basically the circus act known as "human blockhead", but using a soft swab instead of a barn spike. It really isn't a big deal after you make up your mind to do it, but the idea is daunting the first time.
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Well, many of us *are* geeks.
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https://www.fda.gov/media/1361... [fda.gov] (the end of the paragraph that is split between pages 1 and 2)
GET YOUR ASS TO MARS. (Score:2)
"Don't worry, it's self-guiding. Just shove real hard. When you hear a crunch, you're there."
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My kingdom for mod points
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Cause if you do, I'm out.
After I had sinus surgery, my ENT showed me how to stick one of those huge swabs (covered in antibiotic cream) up my nose until I got to the upper sinuses. My wife about passed out when she saw how far up that swab can actually go :) I don't know if the CV swab is the same depth, but I wouldn't be surprised if it is. Once you've done it a few times it's NBD, but at first it's a bit unnerving.
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approved?
msmash needs to stop posting from her phone - stupid AC!
What have they done for RNA stability? (Score:2)
Right, then have police visits. (Score:1)
Just In Case You Didn't Know... (Score:3)
...just how far back that swab has to go?
Here it is, in all of it's glory. [kob.com]
90% reliability (Score:1)
With tests that offer 90% reliability are applied to a 1% infected population. That will mean 9 out of 10 tests will be a false positive. Enjoy your waste of money idiots.
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L.A. County, random sample: approximately 4.1% post-infection.
Chelsea, Mass, questionable sample: approximately 33% post-infection.
What will you blather on about once we find that millions of Americans got this thing in late december or early january?
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I'm not saying there's a lot of under reporting, but I'm pretty sure we would have noticed if millions of people already had it in December and January.
Who knows how many people in NYC have/had it, Burt theyyce already had it kill 0.1% of their population, and their daily death rate is double normal.
It kills enough that it would have been found if millions had it.
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"If so maybe people got it in December and January, why did it take so long for deaths over expected to spike so high and so fast?"
It moves slower on the west coast?
I'm not kidding. We "self isolate" it most of our daily activities in out here. We drive cars and for the most part have crap for public transportation. We don't live on top of each other with the only way in or out of our homes is through an elevator. That's true for most of our work places, too. It's also wamer here and most viruses don'
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The pattern doesn't seem to line up to me.
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All that Subway time shoulder to shoulder.
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"It's also wamer here and most viruses don't like "warm" anything."
Common misconception. Have you noticed that hot countries have been affected just as much? The ambient temperature doesn't have any high degree of effect upon the virus. There are several theories why viruses are "seasonal", and they don't have to do with the temp.
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"Have you noticed that hot countries have been affected just as much?"
India?
Also, I've seen only two actual studies -- one that suggests that covid spreading would slow with warmer weather and one that shows suggests it would not -- but looking the the "not" study -- the methodology used non-covid 19 data to model -- the one that suggested that warmer temperature would slow used actual covid 19. I'm going to go with the study that used covid-19 to model...
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The test is a PCR test. False positives are not a thing that one needs to worry here - it should almost never happen except due to sample contamination. For home testing, contamination at home means somebody at the household likely has the virus, so that isn't a huge problem. Contamination in the lab has the same problems as with any professional testing.
False negatives are a much bigger concern (even professionals don't get it always right, and sometimes the virus is so deep in the airways that it's no lon
Does it work like the real one? (Score:2)
Because then I'm already waiting for the "instructions unclear, took the wrong turn and pierced my eardrum" posts.
Besides, the false positive/negative rates of the professionally administered tests are already nothing too convincing, how much worse will it be if someone without any training will pretend to be a doc?
But hey, if the goal is just to let people pretend they ain't sick so we can send them back to work and save the all-important economy, well, mission accomplished.
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