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)
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.
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.
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)"
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).
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.
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.
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.
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
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.
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."
Limited effectiveness is not the same as ineffective.
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 don't disagree, though it does come down to cost-benefit. Masks are a no-brainer IMO; they're cheap & data generally leans towards them having some level of efficacy even at the lowest ends of the cost-spectrum (ie cloth coverings), and they appear to have rapidly-increasing efficacy as the cost-spectrum value rises (ie N95+, respirators, etc).
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.
There are also checkpoints throughout the airport that monitors with thermal cameras. It's been that way for as long as I can remember whenever I travel there.
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.
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.
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.
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.
