FDA authorizes first Covid-19 test for self-testing at home
fda.gov
fda.gov
It surely must be pretty expensive.
So yes, a big step forward, but not yet what Mina had been advocating.
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....
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).
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.
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?
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.
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://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.
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/
[1] - https://elifesciences.org/articles/55570 (includes bonus GH repo w/ data and methodology)
[2] - https://onlinelibrary.wiley.com/doi/full/10.1002/rmv.2192
Cloth masks are less effective than n95 which are less effective than paprs. So I should not wear any mask unless I can get a papr because they're not as effective?
I should have included the last sentence from that paragraph in the study, because it's pretty concise:
"Therefore, careful consideration should be given to the cost‐benefit of implementing such measures."
IMO it'd be impossible & fruitless to attempt to get even moderate numbers of businesses to do health & temperature screening, much less small businesses; it's just cost-prohibitive, and with the benefit being mediocre at best, there are likely better places to allocate resources.
> 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...
Ct stands for cycle threshold: how many cycles did you need to run the PCR machine before crossing your detection threshold.
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.
I can't find anything in it that says the FDA actually tested this, nor do I find any claims of accuracy in it.
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.