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/
Instead of simply recognizing data accrued over millions of people and evaluating use as EMERGENCY public health tools based on that,

FDA demands each company run literally uninformative trials to compare 30 tests between the rapid test and lab PCR

Sounds easy? Wrong.

4/
They stubbornly continue to ask for rapid tests to be compared to PCR. The two tests are not comparable.

So finding just 30 positives and showing an 80% concordance with PCR is exceedingly difficult Bc PCR stays long for SO long!

So you have to cherry pick each participant

5/
FDA effectively REQUIRES test manufacturers skew their clinical trial participants to an extreme extent so they’re sure to recruit only ppl w high virus load

The FDA evaluation literally measures how savvy you are at recruiting the right ppl, not the test performance

6/
FDA has delayed and delayed nearly every test (except two: Quidel and Abbott) in order to effectively ask the question:

“do you have enough money to work w a savvy trials company to figure out our game of recruiting people in short specific periods of their infection”

7/
In the past couple of months, more rapid tests have gained authorization despite such an exceedingly difficult process - but we don’t have enough.

We could immediately enable the tests that are currently in the queue that have been recognized as the top performers by WHO

8/
Here is a HIGHLY disturbing article about what has gone wrong and the MASSIVE conflict of interest by one of the two ppl who led the EUA process for most of this pandemic:

9/

propublica.org/article/heres-…
To finish this tweet - there 3 exceptionally simple changes that FDA could make to GREATLY speed up the authorization process to days not months/years

10/
First:

Recognize the ample data around the world. Trust our peer nations and offer immediate EUAs to the best companies that are producing and scaling the best across the world.

11/
TWO:

Allow rapid antigen tests to be compared to a gold standard rapid antigen test (BinaxNOW).

Require high bar: >95% positive agreement with BinaxNOW (or >100% even)

Require False Pos rate of <1:2000

This would allow trials to be complete in a few days!

12/
THREE:

Allow EUA test trials to recruit ppl who are already identified as positive

It would GREATLY speed up recruitment if didn’t have to guess who might be a useful participant - and could directly recruit people with virus in their nose.

Pretty obvious

13/
FOUR (adding 1 more)

The should have an outside expert advisory group for tests

Just like vaccines have #ACIP who advise and tell the FDA what qualities of the vaccines to look for (and similar w anti-virals) WHY is there not an outside expert committee to advise on tests.

14

• • •

Missing some Tweet in this thread? You can try to force a refresh
 

Keep Current with Michael Mina

Michael Mina Profile picture

Stay in touch and get notified when new unrolls are available from this author!

Read all threads

This Thread may be Removed Anytime!

PDF

Twitter may remove this content at anytime! Save it as PDF for later use!

Try unrolling a thread yourself!

how to unroll video
  1. Follow @ThreadReaderApp to mention us!

  2. From a Twitter thread mention us with a keyword "unroll"
@threadreaderapp unroll

Practice here first or read more on our help page!

More from @michaelmina_lab

23 Dec
This article captures so well the difficulty, persistence and personal toll it’s taken to help the US (and elsewhere) have the crucial tools we all need to keep society going through this pandemic.

Thank you
@BostonGlobe @hannaskrueger

1/

bos.gl/aA6bkfK
I can’t say I succeeded. If I had, we wouldn’t have long lines and empty shelves. I truly did everything possible and imaginable to me to try to ensure we didn’t end up right here, right now. Blind in the face of a much more infectious virus that is sweeping the globe.

2
A year ago, @hannaskrueger profiled a series of epidemiologists & public health leaders. That, in my view, was a remarkable portrayal of just how difficult the virus had been on many front line workers.

I wish I could say it got better. But 2021 was immensely more difficult

3/
Read 4 tweets
22 Dec
At what point did the science of rapid tests get lost??

FREQUENCY • ACCESSIBILITY • SPEED are most important aspects of a test for public health

Talking about tests not detecting in the 1st 24 hours of contagiousness assumes people are testing in those hours. Most don’t.

1/
Most of the time that someone is contagious is not spent in the first 24 hrs of being contagious. Obviously.

Frequent rapid testing for public health has always been about the sensitivity and EFFECTIVENESS of the testing REGIMEN.

2/
If a test fails to turn pos on d 1 but someone wasn’t using the test that day, then it doesn’t matter

It’s MORE likely ppl use a test sometime in days 2,3,4,5,6 or 7 than day 1. Public health testing also must consider the days it DOES detect - not just the days it doesn’t.

3/
Read 6 tweets
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
21 Dec
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/
Read 5 tweets
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
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

Did Thread Reader help you today?

Support us! We are indie developers!


This site is made by just two indie developers on a laptop doing marketing, support and development! Read more about the story.

Become a Premium Member ($3/month or $30/year) and get exclusive features!

Become Premium

Too expensive? Make a small donation by buying us coffee ($5) or help with server cost ($10)

Donate via Paypal

Or Donate anonymously using crypto!

Ethereum

0xfe58350B80634f60Fa6Dc149a72b4DFbc17D341E copy

Bitcoin

3ATGMxNzCUFzxpMCHL5sWSt4DVtS8UqXpi copy

Thank you for your support!

Follow Us on Twitter!

:(