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Michael Mina Profile picture
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21 Dec, 5 tweets, 2 min read
Well - it’s Finally happening!

US will make 500 million #Rapidtests available for free to Americans

⁦@POTUS⁩ will invoke the Defense Productions Act to make this happen

STARTING in January… but note, *starting* - not all in January

1/ nytimes.com/2021/12/21/us/…
It’s a terrific start and invoking DPA is a great move - I do believe I wrote that we needed to invoke DPA over a year ago!

Though to temper expectations - there’s 350 million ppl in the US and 500 million free tests distributed over a period of months only goes so far

2/
But now the ball is rolling.

Don’t expect to be swimming in rapid tests. Do expect to be able to order them free and the WH will figure out how to keep keeping up.

This is a great start - along with putting @T_Inglesby at the helm in the White House Testing!

3/
If we really wanted to do this right - we could stand up a full operation Warp Speed for Rapid Tests.

Here's but one of so many articles where we've tried to call for this months or as long as 1.5 years ago.

4/
time.com/6096528/operat…
Nevertheless, I am excited about this development. I think this is very good for start for US and although 500 million across 350 million is not massive per person - this has the ability ensure that this process is in place and the US will have tests when needed beyond Omicron

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More from @michaelmina_lab

Michael Mina Profile picture
22 Dec
Here’s a frustrating secret

Today - in midst of Omicron - millions of Americans are begging for access to rapid tests, thousands dying daily.

Get this:

many manufacturers with very high quality rapid tests are begging To ship 100’s of millions of tests to US

But can’t.

1/
These are some of the largest companies in the world that make diagnostic tests.

Their rapid tests have been used the world around in this pandemic with research paper after research paper showing their benefit and quality.

But FDA has them in a holding pattern for months

2/
Why?

Bc despite tremendous amount of data from real world use in millions of ppl - FDA demands the companies check off onerous but remarkably useless check boxes designed for evaluating medical devices.

FDA formally does not recognize that public health testing exists

3/
Read 14 tweets
Michael Mina Profile picture
22 Dec
🧵

Think rapid tests don’t work w Omicron?

In last few days almost everyone I know diagnosed, found out on rapid test & same for MANY MANY others:

PCR test one day - negative.

But then used rapid test day after - BC THEY WERE EASY & ACCESSIBLE & FAST -

Positive

1/
This has never ever been about how good is a single test. Ever.

That ship sailed in Feb 2020 in my view. It’s not about the individual test

I don’t know how to be any clearer

It’s about the testing regimen!

Test once, test again, etc You don’t know when you are infected

2/
A single PCR will not help if it’s a one time thing - Even if weekly. Negative today -positive tomorrow and don’t know it

It is why we published in early 2020 about how we need to focus on serial testing over multiple days

This isn’t a static state

3/
science.org/doi/10.1126/sc…
Read 9 tweets
Michael Mina Profile picture
21 Dec
Rapid tests work!

#Rapidtests given out to people for free in the UK cut hospital stays by a third!

Ppl say - but look there is still transmission. Sure - but it doesn’t mean it wouldn’t have been worse.

A LOT of people are living today Bc of them

1/
theguardian.com/world/2021/dec…
“we found that Liverpool city region’s early rollout of community rapid testing was associated with a 32% fall in Covid-19 hospital admissions after careful matching to other parts of the country in a similar position to Liverpool but without rapid testing”

2/
“We also found that daily lateral flow testing as an alternative to quarantine for people who had been in close contact with a known infected person enabled emergency services to keep key teams such as fire crews in work, underpinning public safety.”

3/
Read 5 tweets
Michael Mina Profile picture
21 Dec
REMINDER

Somewhere over the year the importance of FREQUENCY of tests got lost

NO test is perfect

"Test Sensitivity" is MUCH MORE about frequency

If test fails to turn pos on day 1, check day 2. If pos day 2, you can stop transmission days 2,3,4,5,6

nejm.org/doi/full/10.10…
And yes. I know tests are $$ / unavailable

Believe me, I’ve tried probably more than any human on earth (literally) to have us not arrive where we are:

with a predicted variant overtaking vaccines in a world where no one has access to tests

I am sorry I couldn’t do more

2/
And going back to first tweet. If testing is not frequent then likelihood of testing on day 1,2 is not terribly high so by time you test, you’ll usually be positive if you are infectious. This is how it’s always worked

W Omicron it raises stakes further for speed/frequency

3/
Read 4 tweets
Michael Mina Profile picture
20 Dec
Rapid Test - FDA Analogy:

Person: I want a pair of binoculars to see the moon when hiking

FDA: Great but do they allow you to see Pluto?

P: Umm, no…?

FDA: ah, well, if they can’t help you see Pluto, we deem them illegal for use in the US.

P: What?

FDA: Yep. Get a telescope
This is an analogy to point out how ridiculous it is that the FDA continues, to this day, to require comparison of a rapid antigen test to PCR when they have entirely different qualities and uses.

If FDA wasn’t so stubborn, they’d make the comparison test a BinaxNoW.
Use a high bar against BinaxNoW.

Here, Simple:

For authorization, a new rapid test must achieve 95% sensitivity compared to Abbott BinaxNOW (since we’ve already deemed it appropriate), and must have fewer than 1 in 2000 false positives.
Read 10 tweets
Michael Mina Profile picture
18 Dec
IMPORTANT:

RAPID TESTS DO WORK WITH OMICRON

"But why are some people staying negative in the first days they have symptoms??"

This is expected. Symptoms don't = contagious virus
This is literally a reflection of the fact that vaccines are doing their job!

PLEASE READ Image
Rapid Tests work w Omicron

Omicron is mutated mostly in Spike
Rapid Tests don't detect Spike

They detect nucleocapsid (N)

Omicron has 4 mutations in N

2 were in alpha/delta and were fine

2 are in NTD - a non-immunogenic site - unlikely to impact rapid tests

2/
We can use this “new” relationship between symptom onset and infectiousness to our advantage!

It’s a feature, not a bug. Now that the world has pre-existing immunity, we have to adjust our thinking.

Newly Symptomatic and Ag neg?
Probably not infectious now… test again tmrw

3/
Read 17 tweets

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