FDA authorizes first Covid-19 test for self-testing at home(fda.gov)
fda.gov
FDA authorizes first Covid-19 test for self-testing at home
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-self-testing-home
30 comments
Finally. Medical experts have been wanting this for a while. Dr. Michael Mina was the first to get my attention on how important at-home-tests could be in curbing covid-19. I just wonder why it took them so long? How bad could the side effects be for a test that is a couple of percentage worse than PCR? I think the FDA was too conservative on their timeline for this when we think of how many people are dying today. I also think the FDA is being too conservative on approving the mRNA vaccines, but that is another can of worms.
This isn’t anything like the cheap tests Mina is advocating for... this test actually has some of electric device that actually runs the test. (The release describes a light going off, but not many details)
It surely must be pretty expensive.
It surely must be pretty expensive.
Disposable. Less than $50.
https://www.lucirahealth.com/
https://www.lucirahealth.com/
That’s better than I expected - but still a far cry from the pennies-each paper strips that families would use to test everyone every morning before leaving for work/school.
So yes, a big step forward, but not yet what Mina had been advocating.
So yes, a big step forward, but not yet what Mina had been advocating.
A little-bit-below $50 price range is great as it makes many areas and places able to test, but overall it's still quite expensive. Not everyone is an affluent coastal US developer.
You can see it here: https://www.lucirahealth.com/
I've gone through more than one Covid test. I think it will be difficult to get a proper nasal swap by myself.
Won't the FDA be 'forced' (or rushed) to approve the mRNA Moderna vaccine? I assume this will open the door then for others coming in afterwards.
I did an at home self-test in summer. I believe it was advertised as FDA approved. Now I'm not sure if it was FDA approved at all or FDA approved but not for self-testing at home.
EDIT:
I looked it up, it says: "In compliance with the strict guidelines of the Food and Drug Administration (FDA)"[1]. So, not exactly FDA approved I guess...
[1] "In Übereinstimmung mit den strengen Richtlinien der Food and Drug Administration (FDA)"
https://www.centogene.com/covid-19/test-fuer-zuhause-kaufen....
EDIT:
I looked it up, it says: "In compliance with the strict guidelines of the Food and Drug Administration (FDA)"[1]. So, not exactly FDA approved I guess...
[1] "In Übereinstimmung mit den strengen Richtlinien der Food and Drug Administration (FDA)"
https://www.centogene.com/covid-19/test-fuer-zuhause-kaufen....
This is a normal PCR test that you send in. It's the same as the ones you do in hospitals or airports and not a rapid-testing kit which delivers results within minutes on your couch.
With the massive downside that it still requires professional handling to get a decent swab which most of the people aren't trained for, thereby likely skewing the results (shitty swab = no detection).
In fact, this very same company has a testing center at Hamburg Airport.
(this is a very nice product by the way and certainly helpful aside from the cost, but it just isn't the same category of test which this post refers to).
With the massive downside that it still requires professional handling to get a decent swab which most of the people aren't trained for, thereby likely skewing the results (shitty swab = no detection).
In fact, this very same company has a testing center at Hamburg Airport.
(this is a very nice product by the way and certainly helpful aside from the cost, but it just isn't the same category of test which this post refers to).
Compared to tools like contact tracing, this could be a tangible tool for the general population.
Problem is still availability, but it is great news that we might get something like this.
Even if you have a false positive, people can monitor their health or do another test. False negatives are a problem, but it would still be better than the current situation, so I think there are only advantages.
Problem is still availability, but it is great news that we might get something like this.
Even if you have a false positive, people can monitor their health or do another test. False negatives are a problem, but it would still be better than the current situation, so I think there are only advantages.
I cannot find the specificity and sensitivity numbers anywhere. Are they not published?
Based on what i've heard discussed on this week in virology, I don't think we'll see highly sensitive home tests. Not sure about specificity. But home tests will likely only be sensitive enough to catch most but not all of those who are actively shedding enough virus to be contagious. If we can get the tests deployed widely enough and have everyone tested on a daily basis then even if the tests aren't very good we can get the virus under control quite quickly.
I can't find them either, but I did find this great resource of basically all of the tests approved so far (with the exception of Lucira's):
https://www.fda.gov/medical-devices/coronavirus-disease-2019...
I do wonder if they're using someone else's test and have just wrapped it in an at-home reader?
https://www.fda.gov/medical-devices/coronavirus-disease-2019...
I do wonder if they're using someone else's test and have just wrapped it in an at-home reader?
The Lucira COVID-19 All-In-One Test Kit [1] is a disposable electronic test kit powered by two AA batteries. This is not a Michael Mina $dollar-a-day lick-a-stick that is sensitive to infectious viral loads (PCR CT of 24 or less).
This device is sensitive to equivalent CT values of 37.5 or less coming close to PCR which score viral loads as low as CT of 39 as positive.
Regulators have set the bar too high. We need cheap and easy daily rapid tests that are sensitive to infectious viral loads.
[1] https://www.lucirahealth.com/#the-test-kit
This device is sensitive to equivalent CT values of 37.5 or less coming close to PCR which score viral loads as low as CT of 39 as positive.
Regulators have set the bar too high. We need cheap and easy daily rapid tests that are sensitive to infectious viral loads.
[1] https://www.lucirahealth.com/#the-test-kit
The trouble is, the moment the bar is lowered, the press will run scary articles about how the tests miss large numbers of people that are detected by the PCR test and how there's no evidence that lower CT value equivalents correspond to lower infectivity. This has already basically happened in the UK after the government launched a trial of mass testing an entire city using one of the better and less cheap rapid tests. It undermines confidence in Covid testing as a whole.
Correlation Between 3790 Quantitative Polymerase Chain Reaction–Positives Samples and Positive Cell Cultures, Including 1941 Severe Acute Respiratory Syndrome Coronavirus 2 Isolates [1] paper from Clinical Infectious Diseases:
> It can be observed that at Ct = 25, up to 70% of patients remain positive in culture and that at Ct = 30 this value drops to 20%. At Ct = 35, the value we used to report a positive result for PCR, <3% of cultures are positive.
We need the right tool for the job. A positive daily lick-a-stick screening test should be confirmed with serum IgM and/or PCR testing. Each tool in our toolbox has a sweet spot and tradeoffs.
The key to the daily screening test is that there is only a short window early in the infection that has a CT > 25.
[1] https://academic.oup.com/cid/advance-article/doi/10.1093/cid...
> It can be observed that at Ct = 25, up to 70% of patients remain positive in culture and that at Ct = 30 this value drops to 20%. At Ct = 35, the value we used to report a positive result for PCR, <3% of cultures are positive.
We need the right tool for the job. A positive daily lick-a-stick screening test should be confirmed with serum IgM and/or PCR testing. Each tool in our toolbox has a sweet spot and tradeoffs.
The key to the daily screening test is that there is only a short window early in the infection that has a CT > 25.
[1] https://academic.oup.com/cid/advance-article/doi/10.1093/cid...
> lower CT value equivalents correspond to lower infectivity.
Ct stands for cycle threshold: how many cycles did you need to run the PCR machine before crossing your detection threshold.
Ct stands for cycle threshold: how many cycles did you need to run the PCR machine before crossing your detection threshold.
IFU has a lot more information: https://www.fda.gov/media/143808/download
Great link, this is what everyone's looking for. There's quite a bit of data here, definitely over my head, but I think page 24 has details on the specificity and sensitivity via results of the clinical study.
Screenshot of just that part: https://imgur.com/a/G5JVS2V
Edit: From the EUA itself (linked by someone else above), I find these conditions on their marketing to be hilarious:
"No descriptive printed matter, advertising, or promotional materials, relating to the use of your product may represent or suggest that this test is safe or effective for the detection of SARS-CoV-2."
Which is then immediately followed by (emphasis added):
"Z. All descriptive printed matter, advertising, and promotional materials, relating to the use of your product shall clearly and conspicuously state that:
· This home test kit has not been FDA cleared or approved;
· This home test kit has been authorized by FDA under an EUA;
· This home test kit has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and ..."
Which is it -- authorized for the safe & effective detection of SARS-Cov-2, or authorized for sale but NOT safe and/or effective? Also, the EUA requires them to build a "results reporting website/portal" within 4-months.
Idk, it sure seems like a non-zero amount of subjective bureaucracy to me.
Screenshot of just that part: https://imgur.com/a/G5JVS2V
Edit: From the EUA itself (linked by someone else above), I find these conditions on their marketing to be hilarious:
"No descriptive printed matter, advertising, or promotional materials, relating to the use of your product may represent or suggest that this test is safe or effective for the detection of SARS-CoV-2."
Which is then immediately followed by (emphasis added):
"Z. All descriptive printed matter, advertising, and promotional materials, relating to the use of your product shall clearly and conspicuously state that:
· This home test kit has not been FDA cleared or approved;
· This home test kit has been authorized by FDA under an EUA;
· This home test kit has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and ..."
Which is it -- authorized for the safe & effective detection of SARS-Cov-2, or authorized for sale but NOT safe and/or effective? Also, the EUA requires them to build a "results reporting website/portal" within 4-months.
Idk, it sure seems like a non-zero amount of subjective bureaucracy to me.
Yes, it's authorized for sale under an EUA, but it's not been proven safe and effective according to the normal 510k process. "Safe and Effective" is essentially a legal term that means it's passed this process.
Here is the actual approval letter: https://www.fda.gov/media/143810/download
I can't find anything in it that says the FDA actually tested this, nor do I find any claims of accuracy in it.
I can't find anything in it that says the FDA actually tested this, nor do I find any claims of accuracy in it.
That’s Emergency Use Authorization for you
Its sad because I’ve seen all the grifters and sales people and clients not know the difference between any with FDA recognition and its actual status
I think the FDA is doing more harm than good here. Like, the product just being brought to the market in a world without any FDA gatekeeper would give people more rational thought than our reality.
Its sad because I’ve seen all the grifters and sales people and clients not know the difference between any with FDA recognition and its actual status
I think the FDA is doing more harm than good here. Like, the product just being brought to the market in a world without any FDA gatekeeper would give people more rational thought than our reality.
[deleted]
Don’t see anyone mention this here but it’s worth noting this company is a YC company