First at-home rapid test w FDA EUA! This is a great milestone! Congratulations to @EllumeHealth on this triumph. The EUA for this at-home test should be celebrated. I am supportive & have used it myself! I want to put this in context...
This is a terrific milestone. An OTC rapid test is a great advance. It means some will have access to much needed test to help know status, without going through barriers of an MD.
Since many are asking, this is not quite THE public health screening test I'm calling for.
2/10
Inside, @Ellume (right) has simple but powerful paper strip test. It requires battery, circuits, sensors, and bluetooth with a mobile phone. Thus, not quite THE mass public health screening test that will scale for frequent use by millions (i.e. vs simple one on left).
3/10
Rather, this is great tool to buy once/twice for ~$30?? (Not sure of price).
That Ellume got an OTC claim for this is great!! I do not want or intend to diminish this needed achievement at all.
However - I think (for FDA OTC) it means most dominoes should now fall....
4/10
There is now no good reason I can see to tests be fully by prescription only, since MD prescription is more about whether someone can understand what it means to be positive or negative. Once one is enabled, all should be considered for OTC (non-prescription).
5/10
By making a test OTC (or 2-Pixel lab-based PCR is OTC)-it begs question of whether any tests should remain prescription only. I do not think so. However, if they are not, we must have public health distribution - else I fear will all be bought up by rich and powerful.
6/10
By keeping these purely in the free market is a potential disaster given overall lack of public health agency to have a coordinated response.
I do not want to see the wealthy have access but the poor have none.
That is one of the saddest endpoints of all of this.
7/10
So... I am delighted to see the FDA giving OTC claims for rapid tests & this @EllumeHealth test will absolutely be a great addition!
8/10
IMO this test, because it's a bit more $$ and more limited supply, should, ironically, probably be considered along lines of a medical device versus tests like the BinaxNOW - simple paper strips - which are the more frequent accessible public health devices we need.
9/10
To conclude, I am in full support of tests making way out to OTC & think this will be a great addition!
I do hope it doesn't drive more of a wedge between haves and have-nots and hope it is the start of a major increase in fast, frequent, accessible tests.
10/10
My mistake. I posted the wrong NPR article.
Here is what I meant to post. npr.org/sections/healt…
I posted the wrong @NPR article at the top of this thread.
Here is what I meant to post Re @EllumeHealth gaining EUA.
On Wednesday I spoke first to the @Heritage Foundation and immediately after to the @NewDemCoalition
1/
Here is a link for the first talk, with the @Heritage Foundation - I believe there is a video recording of the event there, with @paulmromer and Doug Badger, moderated by Marie Fishpaw
One of my favorite scientific themes is the identification of within-host immune kinetics from population data.
The divergence of the curves following pfizer #COVID19 vaccine at around day 10 demonstrates perfectly the time required for antibody secreting cells to proliferate
Have a #COVID19 test results that took more than a few days after the swab was taken??
Throw it out and refuse to pay!
A lab result delayed more than a couple days isn’t just not useful, it’s misleading and dangerous!
A test with a 4+ day turnaround should have EUA revoked.
The only way it’s useful is if it’s positive. Remember, start the isolation clock from the time of the swab. Not the result.
Also, I’m not blaming the labs here. Im highlighting a massive systemic problem.
Though I will say that all clinical labs have a responsibility to accept only specimens that they can process within a clinically relevant time. A 7-day turnaround does more harm than good.
Getting tested during a pandemic is mostly to keep others around us safe. If +ve, the test wont change that
• Tests for #COVID19 should NOT require MD order
• No person should have to pay for a test intended to help them not infect others
This is Public Health, not medicine
Testing is also performed for medicine, of course.
And if you end up in the doctors office b/c you're sick-all bets are off w regard to pay (I'm not wading into chargemaster wars!)
But if getting a test simply b/c you don't want to infect others... you should NOT have to pay.
Also- lets be honest - the questionnaire to get a test to get an automatic doctors prescription from some doctor you don't know and will never talk to... it's complete BS.
It hikes up prices, plays into a medical versus a concerted public health response and offers little else
I think going back and seeing what we got right and what we got wrong, in hindsight, will be an important exercise to help us understand, with some objectivity, what tools/models will be most useful in future pandemics and what are total rubbish.