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Michael Mina Profile picture
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21 Oct, 5 tweets, 2 min read
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Remarkably IMPORTANT letter from Senator Durbin - Majority whip - urging FDA to recognize testing for PUBLIC HEALTH as distinct from medical diagnosis & rapid Ag tests should not be compared to PCR for EUA, but rather another rapid Ag test

1/
durbin.senate.gov/imo/media/doc/…
Why is this important?

Because the US still is in need of greater access to inexpensive rapid tests

One of the main barriers preventing Americans from accessing many high quality tests used successfully around the world is a high regulatory burden for public health tests

2/
The regulation of these tests by the FDA is 100% appropriate for MEDICAL devices used by doctors to diagnose individuals.

But for Public health tests, we need regulation that focuses on what these tests are meant to do. Answer the question "Am I Infectious Right Now?"

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For this question, then comparisons of rapid antigen tests against medical PCR tests is like comparing an X-ray to an MRI for authorization of the X-ray machine.

This would be ridiculous - the two have different reasons for their use - and the metrics should be different.

4/
We wrote about this recently in the @nytimes here:

nytimes.com/2021/10/01/opi…

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More from @michaelmina_lab

Michael Mina Profile picture
6 Oct
THREAD: Some thoughts on this White House Report on Testing...

1/
The extra $1B towards purchasing rapid tests is a great step forward. It is a strong signal that the WH and the Federal government is recognizing that American's are demanding to be able to know if they are infectious in real time.

So I'm fully supportive of the WH support

2/
A question was just asked to @CDCDirector about whether roll out of rapid tests will limit the public health reporting

This is an important question and a good reason the federal government should simultaneously prop up efforts to make these tests verifiable and reported.

3/
Read 7 tweets
Michael Mina Profile picture
6 Oct
HUGE News!

White House finally recognizing crucial need for rapid tests as we get through this most recent wave of COVID (& after 700K lives lost)

This is good news & a show of support for public health from the White House and the FDA

However...

1/
 washingtonpost.com/health/2021/10…
We Should be careful to take this in stride. We've seen similar announcements in the past. FDA press release, media attention, WH remarks and then little to no change.

The FDA EUA for ACON rapid tests is a terrific step forward!!

But is it enough...?
2/
I would argue that it is not enough. There are many many many very high quality tests out in the world that simply do not exist in the US market bc of the approach we take to regulating these tests.

As I've mentioned in the past...

3/
Read 8 tweets
Michael Mina Profile picture
1 Oct
1/ Thread

While vaccines are most effective tool to protect us all from severe disease

#RapidTests answering “Am I Infectious Now?” are an answer to society *living* with Covid-19

New @NYTOpinion @nytimes by me and Steven Philips @TheCOVIDCollab

nytimes.com/2021/10/01/opi…
@nytopinion @nytimes @TheCOVIDCollab 2/

FINALLY Americans are seeing the value of at-home rapid tests, and demanding them to help keep their families, friends, neighbors safe and schools and businesses running.

But now the US govt needs to make more highly accurate rapid tests available to meet that demand.
@nytopinion @nytimes @TheCOVIDCollab 3/

In many parts of world, rapid testing is commonplace. Policymakers recognized early that rapid tests could blunt the pandemic by scuttling transmission chains. They created special regulatory pathways to evaluate these tests, quickly & effectively

nytimes.com/2021/06/09/wor….
Read 11 tweets
Michael Mina Profile picture
24 Sep
Thread On tests and the media

It is almost universal that any piece discussing Rapid Ag tests says “PCR is more accurate but…”

But even this isn’t true. It simply depends what you want to detect.

If wanting to identify ppl who are contagious, PCR is much less accurate.

1/
If your goal is to detect ppl are infectious, a rapid Ag test is highly sensitive AND specific for this.

PCR is not specific for this. It will read positive even when not infectious. So… it’s less accurate for the public health question at hand “am I infectious”

2/
You might say… well PCR is much more sensitive. But even that is not true. A bit more, yes, but if wanting to catch infectious ppl, it’s really but that much more sensitive and, if that’s your goal, then PCR is massively LESS effective than a rapid test.

3/
Read 7 tweets
Michael Mina Profile picture
19 Sep
@MarkZlochin @CircusPubes @DrPathHero1 yes.

A very important piece is the temporal relationship between when viral RNA is highest, when antigen tests are highest sensitivity and when people are most likely to be infectious following exposure. While almost no studies directly observe all three together...
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@MarkZlochin @CircusPubes @DrPathHero1 They all fall directly in line with the exact same time period after exposure or - when symptoms are demonstrated, with the same period surrounding onset of symptoms.

So we really do not need empirical data showing transmission and viral load since the kinetics show it all

2/
@MarkZlochin @CircusPubes @DrPathHero1 A major problem obtaining the direct empirical data is that if someone is testing, they likely aren't infecting others. So, people who are infecting others, you simply are not getting their swab at the same time as they are infecting. So relationships are skewed.
Read 5 tweets
Michael Mina Profile picture
17 Sep
To battle COVID, Biden's Action Plan boldy calls for scaling rapid tests! & requires millions of Americans to vaccinate or test

But now the timer is set. W/out immediate change, we will see PCR delays of 3-10 days & rapid test shelves remain largely empty

We can avoid this.
1/
Luckily, the issue is a simple one to fix (all things considered).

The tests exist in HUGE numbers across the globe. Just not in the US. The reason? We've asked the FDA to take on an impossible task... to evaluate high quality PUBLIC HEALTH tools, when this is not their job

2/
The FDA evaluates medical devices - and does not evaluate public health tools

This is THE problem. As long as we consider rapid tests as medical devices (they're not - they're PUBLIC HEALTH transmission detection tools) FDA is forced to fit a square peg in a round hole

3/
Read 8 tweets

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