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


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...?
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...

There are approaches to massively accelerate access to tests so that any American can have a stock of rapid tests at their home, for use whenever they want.

UK and Germany among others have this type of access. We can too... But it may require executive action....
American's want to enjoy Thanksgiving and the holidays without worry of infecting each other as they gather. We can get rapid tests to every household in weeks, not 6 months.

US Gov can accelerate this effort. We wrote how here:

This is a previous thread that discusses what needs to be done and why.

There are other items too...


We can't simply produce tests and assume theyll eliminate spread

We need strategy

Just as USG is supporting purchase of tests, they should support businesses & schools by providing critical tools that will enable the tests to be reliably used.


If we scale to 200 million tests per month by February - that may sound like a whole lot of tests. And it is. But is it commensurate with the US public health need?

It is ~1 rapid test per American every two months. Not sufficient for the actual need. And not soon enough


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More from @michaelmina_lab

6 Oct
THREAD: Some thoughts on this White House Report on Testing...


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

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.

Read 7 tweets
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…
@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….
Read 11 tweets
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.

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”

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.

Read 7 tweets
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...
@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

@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
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.
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

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

Read 8 tweets
16 Sep

Its common to say ALL kids mask during school, w out mention of daily rapid tests for entry

Yet, it’s heresy to suggest ALL kids test daily and go maskless

- Poor fitting Masks cut transmission, maybe <50%

- Rapid tests cut risk of infectious entering by >90%
I’m NOT suggesting we not do both. But dilemma is:

Why is it that when masks are discussed, rapid tests in AM are not. BUT when rapid tests in AM are discussed, it has to always be followed by “And masks too”.

Demonstrates group think rather than science backed decisions

We DO need rapid test supply. Many ways to make it happen. Change of how they are designated (as a public health tool) is first step in my view so that we can massively accelerate access and scale

Read 5 tweets

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