7 ms·

FDA authorizes first Covid-19 test for self-testing at home

115 points by dr_ 6y ago

deleted 6y ago
[deleted]
mertd 6y ago
I cannot find the specificity and sensitivity numbers anywhere. Are they not published?
- mikeyouse 6y ago
  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-covid-19-emergency-use-authorizations-medical-devices/eua-authorized-serology-test-performance 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?
  - tcoff91 6y ago
    Those are serology tests. totally different.
    - mikeyouse 6y ago
      Ah yeah, fair.
- tcoff91 6y ago
  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.
fasteddie31003 6y ago
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.
- zwily 6y ago
  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.
  - SparkyMcUnicorn 6y ago
    Disposable. Less than $50. https://www.lucirahealth.com/ https://www.lucirahealth.com/
    - est31 6y ago
      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.
    - wtfusa 6y ago
      Wait, you have to PAY for tests? WTF?
    - zwily 6y ago
      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.
  - 6y ago
ElijahLynn 6y ago
Here is the actual approval letter: https://www.fda.gov/media/143810/download 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.
- vmception 6y ago
  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.
cameldrv 6y ago
IFU has a lot more information: https://www.fda.gov/media/143808/download https://www.fda.gov/media/143808/download
- adanto6840 6y ago
  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 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.
  - cameldrv 6y ago
    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.
raxxorrax 6y ago
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.
weinzierl 6y ago
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.html https://www.centogene.com/covid-19/test-fuer-zuhause-kaufen....
- neuronic 6y ago
  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).
jonsno56 6y ago
New York has been sending care packages with Covid tests. Curious what test they’re using
sradman 6y ago
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 https://www.lucirahealth.com/#the-test-kit
- wavegeek 6y ago
  There is a rapid cheap test for covid-19 infection. It consists of checking whether a person has cold/flu symptoms and/or a temperature over 37.5. This test may sound ridiculous but it is part of the reason why Taiwan has had hardly any deaths from the virus and yet did not have to have a lockdown. In Taiwan, checks are made at entrance to work, school, transport, shops. Those who have symptoms as above are excluded. This, combined with other measures (below) has been enough to produce successful control of the disease. Some numbers Country, deaths/million, GDP fall Q2/2020 Taiwan,0.3,-0.6 Australia,35,-7.0 Germany,158,-11.2 Sweden,167,-8.3 USA,767,-9.6 Belgium,1278,-14.5 https://www.worldometers.info/coronavirus/#countries https://www.worldometers.info/coronavirus/#countries https://ourworldindata.org/covid-health-economy https://ourworldindata.org/covid-health-economy Measures Taiwan took 1. Close borders as hard as possible very early. 2. Strictly and competently managed mandatory quarantine of overseas arrivals. 3. Mandatory facemasks. Initially supplies were rationed until supplied caught up. 4. Health checks as above. 5. Competently managed contact tracing. Some of this strategy may be difficult to duplicate in certain countries. See the steps with the word "competent" included. Also the Taiwanese public appear to trust the government's competence and good intentions, something that does not seem to be true in some other countries.
  - adanto6840 6y ago
    The studies & data on "health checks" -- temperature checks, symptom screening, etc -- thus far shows that it is generally considered to not be very effective. Here are 3 studies I found quickly, but this line from [2] sums it up nicely: "... screening is resource intensive and its effectiveness is limited due to a high proportion of asymptomatic or pre‐symptomatic cases, resulting in low detection rates." [0] - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7014668/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7014668/ [1] - https://elifesciences.org/articles/55570 https://elifesciences.org/articles/55570 (includes bonus GH repo w/ data and methodology) [2] - https://onlinelibrary.wiley.com/doi/full/10.1002/rmv.2192 https://onlinelibrary.wiley.com/doi/full/10.1002/rmv.2192
hikerclimber 6y ago
I hope this doesn't work. I hope they miss diagnosis someone and they die. I also hope the number of deaths in U.S. keep going up and also hope masks don't work anymore after virus mutates. :)
seehafer 6y ago
Don’t see anyone mention this here but it’s worth noting this company is a YC company

115 points by dr_ 6y ago

deleted 6y ago

[deleted]

mertd 6y ago

I cannot find the specificity and sensitivity numbers anywhere. Are they not published?

mikeyouse 6y ago
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-covid-19-emergency-use-authorizations-medical-devices/eua-authorized-serology-test-performance 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?
- tcoff91 6y ago
  Those are serology tests. totally different.
  - mikeyouse 6y ago
    Ah yeah, fair.
tcoff91 6y ago
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.

fasteddie31003 6y ago

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.

zwily 6y ago
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.
- SparkyMcUnicorn 6y ago
  Disposable. Less than $50. https://www.lucirahealth.com/ https://www.lucirahealth.com/
  - est31 6y ago
    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.
  - wtfusa 6y ago
    Wait, you have to PAY for tests? WTF?
  - zwily 6y ago
    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.
- 6y ago

ElijahLynn 6y ago

Here is the actual approval letter: https://www.fda.gov/media/143810/download 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.

vmception 6y ago
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.

cameldrv 6y ago

IFU has a lot more information: https://www.fda.gov/media/143808/download https://www.fda.gov/media/143808/download

adanto6840 6y ago
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 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.
- cameldrv 6y ago
  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.

raxxorrax 6y ago

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.

weinzierl 6y ago

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.html https://www.centogene.com/covid-19/test-fuer-zuhause-kaufen....

neuronic 6y ago
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).

jonsno56 6y ago

New York has been sending care packages with Covid tests. Curious what test they’re using

sradman 6y ago

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 https://www.lucirahealth.com/#the-test-kit

wavegeek 6y ago
There is a rapid cheap test for covid-19 infection. It consists of checking whether a person has cold/flu symptoms and/or a temperature over 37.5. This test may sound ridiculous but it is part of the reason why Taiwan has had hardly any deaths from the virus and yet did not have to have a lockdown. In Taiwan, checks are made at entrance to work, school, transport, shops. Those who have symptoms as above are excluded. This, combined with other measures (below) has been enough to produce successful control of the disease. Some numbers Country, deaths/million, GDP fall Q2/2020 Taiwan,0.3,-0.6 Australia,35,-7.0 Germany,158,-11.2 Sweden,167,-8.3 USA,767,-9.6 Belgium,1278,-14.5 https://www.worldometers.info/coronavirus/#countries https://www.worldometers.info/coronavirus/#countries https://ourworldindata.org/covid-health-economy https://ourworldindata.org/covid-health-economy Measures Taiwan took 1. Close borders as hard as possible very early. 2. Strictly and competently managed mandatory quarantine of overseas arrivals. 3. Mandatory facemasks. Initially supplies were rationed until supplied caught up. 4. Health checks as above. 5. Competently managed contact tracing. Some of this strategy may be difficult to duplicate in certain countries. See the steps with the word "competent" included. Also the Taiwanese public appear to trust the government's competence and good intentions, something that does not seem to be true in some other countries.
- adanto6840 6y ago
  The studies & data on "health checks" -- temperature checks, symptom screening, etc -- thus far shows that it is generally considered to not be very effective. Here are 3 studies I found quickly, but this line from [2] sums it up nicely: "... screening is resource intensive and its effectiveness is limited due to a high proportion of asymptomatic or pre‐symptomatic cases, resulting in low detection rates." [0] - https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7014668/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7014668/ [1] - https://elifesciences.org/articles/55570 https://elifesciences.org/articles/55570 (includes bonus GH repo w/ data and methodology) [2] - https://onlinelibrary.wiley.com/doi/full/10.1002/rmv.2192 https://onlinelibrary.wiley.com/doi/full/10.1002/rmv.2192

hikerclimber 6y ago

I hope this doesn't work. I hope they miss diagnosis someone and they die. I also hope the number of deaths in U.S. keep going up and also hope masks don't work anymore after virus mutates. :)

seehafer 6y ago

Don’t see anyone mention this here but it’s worth noting this company is a YC company