FDA Authorizes 1st Home Coronavirus Test That Doesn't Require A Prescription (npr.org) 61
The U.S. Food and Drug Administration on Tuesday authorized the first coronavirus test that people will be able to buy at a local store without a prescription and use for immediate results at home to find out if they're positive or negative. From a report: The test will cost about $30 and be available by January, according to the Australian company that makes it, Ellume. The FDA had previously authorized other tests that let people avoid long lines by collecting a sample themselves at home. But those tests require people to send the sample to a lab and wait for the results. Another recently authorized test doesn't have to be sent off to a lab, but it requires a prescription to get it.
The new test is the first that people will be able to buy without a prescription at a local store and do entirely at home on their own. It takes about five minutes to collect the sample and produces results within 15 minutes. "Today's authorization is a major milestone in diagnostic testing for COVID-19," FDA Commissioner Stephen Hahn said in a statement announcing the authorization.
The new test is the first that people will be able to buy without a prescription at a local store and do entirely at home on their own. It takes about five minutes to collect the sample and produces results within 15 minutes. "Today's authorization is a major milestone in diagnostic testing for COVID-19," FDA Commissioner Stephen Hahn said in a statement announcing the authorization.
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They'll just need to buy a home first.
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i just hope.. it works?
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Doesn't matter if it works or not. This is the age of scalper bots. You won't be able to get one for anywhere near $30.
Re:about $30 (Score:5, Insightful)
If I knew I'd had it, and been one of the lucky folks to not have any symptoms, I"d be MUCH more likely to start back going out to restaurants, movies, etc...and supporting local businesses in person.
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Well, seems the governments would WANT to know this, to be able to better target the vaccines to those that need it the most and don't have any immunity and let those that have had the disease not have to take the vaccine.
I mean at thi
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Here you go...
https://www.drugtestingsupplie... [drugtestingsupplies.com]
https://www.btnx.com/Product?i... [btnx.com]
https://www.accubiotech.com/pr... [accubiotech.com]
These all seem to be Rx only. However, they are available...
I've used one of these and tested negative.
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Unfortunately, the kind of antibodies these simple tests look for tend to fade away after a few months, and people with less severe infections often make fewer of them in the first place. The tests are calibrated with blood samples from hospitalized patients, so detecting someone who had an asymptomatic infection several months ago is a crapshoot. T-cell tests and neutralizing antibody tests might do it, but they are more complicated and expensive, and not really available yet.
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I could test if I've been fortunate enough to have already had covid and not have to really worry so much about it anymore.
What makes you think that having had it makes you immune from getting it again? I mean we've already got plenty of cases of the opposite, not only that we've got some evidence that getting it a second time is significantly worse than the first.
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That's quite the opposite of what I've seen/read.
It appears a very very few novel cases of people catching it a 2nd time are out there, like in the number you can count on 2 hands....and so far, the results were far less than the original time they caught it, often
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It almost certainly works -- to some degree. Getting an antibody test that will react to some concentration of antigen is not particularly hard. The question is for what uses does it work *well* enough for? And will people understand the difference between where it's useful and not?
For asymptomatic patients, this test doesn't tell you much. It has a 9% false negative rate and a 4% false positive in that case. Except in some unusual circumstances, your chance of being infected if you're showing no sympto
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In most cases it either tells you what you already know or tells you to get a PCR test. I think the most useful case may be when someone has symptoms but is in denial.
I agree. I do see it being at least slightly useful in other cases - for instance, my roommate was sent home for over a week for having a bad cough. He had to get tested at CVS and it took the full week to get his results back. Though his test came back negative, it would have been a humongous relief to have taken the home test first.
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99.97% chance of survival*
*with hospital care that wouldn't be available if overloaded. Also 'survive' only means not die,there may still be lifelong effects afterwards.
Re: about $30 (Score:2)
God Dammit Health Care Monster, I ain't gonna give you no tree-urthy!
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And I can't wait to find out what the false negative rate is. The false positive rate is, of course, also important, but not as important as the false negative rate.
Drive-Through - $75/test (Score:4, Informative)
Stayed in the car. Kids noses swabbed. Results in an hour (negative). Easy.
There was a "potential exposure" so I had to get them tested before they were allowed back to school.
School shut down today after only 3 weeks open. Still zero positive cases.
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An hour. Jeesh that's backwards. I got my result in 4 minutes at my last test. (I get a test weekly for work reasons and the introduction of a test that didn't get sent overnight to a lab was a gamechanger).
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Even socially progressive fiscally conservative individuals question your assumption.
Re: It should be free (Score:1)
Well, if you don't let the take any profit, and automate everything that can be, the price will likely be ... about three-fiddy.
Cents. Not dollars.
But what he means: Why aren't we manufacturing it ourselves, and paying for that collectively? At that above low price. Paid as a general tax. After all, everyone needs it. Eactly what a government is for.
(Yes, you need others to be healthy too, even if you "ain't got no corona".)
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When a person doing something benefits the society as a whole more than the cost, it makes sense for the society (through taxes collected by the government) to pay for the cost of that action.
More people testing for Covid-19 and having the infected quarantined and treated, thus reducing the spread, generally benefits the entire country for more than the $30 the kit cost, so it make more sense to let people test for free. The problem is how to avoid abuse.
If the US had socialized medicine, then the test kit
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By free do you mean someone other than you else has to pay for it?
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Antibody test (Score:3)
Re:Antibody test (Score:5, Interesting)
I'd a like a test to find out if I've already been exposed.
Donate blood (sorry if you can't). My local blood bank has been testing for COVID antibodies since October. So you get a free test and get to help others.
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I was told antibodies are only around for a short time. And the true test is T-cells.
So you could have been exposed and fought off the virus early, lost the antibodies but still have the ability to ramp up production?
http://www.differencebetween.n... [differencebetween.net]
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So go get an anti-body test. ... Are they not offered in your country? Most western countries offer voluntary anti-body tests if you're willing to pay for it (~$50, though if you're in the USA I'm sure it's $5000).
But really why do you want to know if you've already had it? We've got plenty of evidence that having had it before doesn't make you immune from getting it again, and we've also got evidence that getting it again is far worse than the first round.
Ugh, it's an app-connected test. (Score:4, Informative)
From TFA:
Users add a few drops of liquid to the sample and place it into a small plastic device that looks like a home pregnancy test. Results are wirelessly transmitted to a smartphone app within about 15 minutes.
Great, smartphone app required. Even if I didn't have privacy concerns, probably won't work on older phones like mine.
Re:Ugh, it's an app-connected test. (Score:5, Informative)
From TFA:
Users add a few drops of liquid to the sample and place it into a small plastic device that looks like a home pregnancy test. Results are wirelessly transmitted to a smartphone app within about 15 minutes.
Great, smartphone app required. Even if I didn't have privacy concerns, probably won't work on older phones like mine.
And from page 3 of the FDA letter [fda.gov]:
Test results from your product will be automatically reported to relevant public health authorities, via your product’s software application (app), in accordance with local, state, and federal requirements, using appropriate LOINC and SNOMED codes, as defined by the “Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests” provided by the Centers for Disease Control and Prevention (CDC).
So, have fun with that.
Re:Ugh, it's an app-connected test. (Score:4)
yeah hard pass.
the privacy aspect was about the only compelling reason to do this test vs one at a clinic.
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Test results from your product will be automatically reported to relevant public health authorities, via your productâ(TM)s software application (app)
What prevents you from filling in the form for the app with a fake name and address... apps have no way to inherently know who you are without further input.
Re: Ugh, it's an app-connected test. (Score:2)
So it's a fuckin trap. (Score:2)
What a bunch of assholes.
At least be upfront about it!
i have no problem telling the docs my test was positive so please make a real test while I go into quarantine.
But I DO have a problem with this bullshit fuckery!
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The real privacy concern with the app (or any app) is: who else gets access to the data, besides the people you know about. (The relevant public health authorities, in this case.)
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Well that will work great in the future when testing will be required for you to take a flight or go pretty much anywhere.
1. By a home test
2. Put it in you rectum
3. Test negative
4. Get results automatically uploaded
5. ???
6. Profit!
Re: Ugh, it's an app-connected test. (Score:2)
Not the first in the world (Score:2)
I don't know if your health workers get them but staff in the UK NHS do.
Yes they look like pregnancy tests but, like pregnancy tests, they do not need an app. That will be there either to make it more sales staff friendly (by raising the price) or just to help "them" to keep an eye on you.
I am expected to do one of these twice a week. It's very easy and the testing takes perhaps 5 minutes to do and then 30 minutes to wait for the thing to show a line or two reminiscent of that stick that someone had to w
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oblig xkcd (Score:1)
Tests should be heavily subsidized (Score:4, Interesting)
I think these tests should be basically free to all who want them, and the government should consider it an investment in the country's future, as well as the world's future. In an interview with CBC's Quirks and Quarks [www.cbc.ca], Dr. Michael Mina "said the best real world example of how rapid antigen testing could work is Slovakia, which until very recently was experiencing a severe outbreak. The country tested about a half to two thirds of the population with rapid antigen tests once a week for a couple of weeks, 'and very quickly, they saw the amount of virus in the population dropped by about 50 per cent in just a week or two.' Given the heavy economic and mental toll the pandemic is having on people, Mina said countries like the United States and Canada could benefit strongly by deploying rapid antigen tests in communities where the virus is currently out of control."
Oddly enough, in TFA Dr. Mina seems to contradict what he said on CBC, saying that "from the perspective of truly stopping or massively slowing this pandemic, this test isn't designed for that". My guess is that he's talking about the (stupidly high) cost of the tests as a barrier to widespread adoption, but I wish he'd been clearer in his comments. But the case for quick, readily available testing seems awfully strong, and our governments are foolish not to be rolling it out as widely as possible, at a low enough cost for the vast majority of people to be able to test themselves frequently.
Re: Tests should be heavily subsidized (Score:2)
You didn't read the fine print.
It's a trap to publish your health status to a badly secured database for profit. Can't see the result without the appitty app app.
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Thanks for the heads-up - I had totally missed that point. So it seems whoever is promoting these things is more interested in data mining and invading privacy than in halting the pandemic. And that device that transmits results to a smartphone explains why the cost is so high. The folks who decided to buy this are evil bastards looking to victimize suckers, and the company that created it is equally evil for having a business model predicated on bastards and suckers.
Reliability? (Score:2)
What's the rate of false positives and false negatives?
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Plenty of both. Not as accurate as a PCR test.
So people who don't have COVID will be quarantining, and people with COVID will be merrily out and about spreading it.
It's not clear to me if this will be any use at all.
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PCR isn't very accurate at detecting infectiousness in practice:
https://swprs.org/the-trouble-... [swprs.org]
Basically many studies have concluded that PCR testing over 25 iterations gives far too many false positives when seroprevalence testing is done as a follow up.
Most countries are over 35 iterations in testing some 45, at 35 iterations the false positive (of being infectious) is near 97%, at 25 iterations its still near 20% false:
https://academic.oup.com/cid/a... [oup.com]
https://www.thelancet.com/jour... [thelancet.com]
Lots of other stu