THREAD:

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...

npr.org/sections/coron…

1/10
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.

npr.org/sections/healt…

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More from @michaelmina_lab

14 Dec
It PAINS & infuriates me that we continue a path of INACTION beyond a vaccine

Deaths are increasing. Yet our leaders CHOOSE to do nothing

The nation should be in an uproar!

We could ALL know our infection status daily & stop #COVID19

Instead our leaders choose dying
Pathetic.
Vaccines are great - But not getting to everyone now - and not for many months.

We have a tool now that could allow society to run MUCH safer.

Holidays spent MUCH safer
Stores and restaurants open and MUCH safer
Schools MUCH safer

This is doable, now-if our leaders wanted it.
Today, we have US companies making millions of rapid tests that people COULD be using to:

Know if their child is bringing SARS-CoV-2 virus back from school
Safely go to work, dine at restaurant, shop for groceries.

Instead US companies are forced to ship them overseas.
Read 5 tweets
12 Dec
There aren't many bipartisan items in Congress these days

But there is one thing
• Frequent • Accessible • Rapid • At-Home Testing

To help curb the spread of #COVID19

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

2/
heritage.org/public-health/…
Read 4 tweets
9 Dec
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
the data for this graph - and the graph itself is from fda.gov/media/144245/d…
Here, we identified the immunological consequences of measles infections on immunity based on population level data.

science.sciencemag.org/content/348/62…
Read 4 tweets
2 Dec
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.
Read 5 tweets
1 Dec
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
Read 4 tweets
30 Nov
Interesting to listen to how we were thinking in April vs today

This interview w @bbcworldservice on April 21 asks question "How likely are children to spread #COVID19"

We didn't have data- but models showed (correctly) kids are important in spread

bbc.co.uk/sounds/play/p0…
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.
Read 4 tweets

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