@US_FDA’s remarkably vague (likely false) statement w ZERO supporting information that serves only to damage confidence in one of the best tools we have is insane

The data FDA offers is:

“early data suggests… rapid tests MAY have reduced sensitivity”

fda.gov/medical-device…
Because of this line - with no supporting information - effectively every major news outlet today has reported that rapid tests are less sensitive to detect Omicron.

But the actual data suggests otherwise. Omicron is not mutated where the tests detect.

2/
It’s a bit like saying

“I got plastic Surgery on my face”

and FDA says

“Oh, Your shoes may not fit you anymore”

The reality is the tests likely detect Omicron same as they did Delta… but Omicron is more infectious so any test will have a harder time picking up at first

3/
If there IS a reason antigen tests are not picking up Omicron as well, FDA should come out and say what it is or at the very least say which tests are less sensitive

But UK says quite the opposite - that they perform fine

Biologically they should be no different

4/
Between the vague, likely wrong FDA notice & the CDC fully swinging 180 & falsely saying rapid test positives are meaningless as a risk factor for transmission (FALSE), it feels like a concerted effort to gaslight the nation bc tests never became adequately accessible

5/

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More from @michaelmina_lab

30 Dec 21
Misleading

This is referring to transmission over time IN THE AVERAGE case, and there, 10% of one’s transmissibility may be after day 5.

But being an average, there may be a full 30%+ of people who are greater than average & remain highly infectious through days 6,7,8

🧵

1/
In addition the AVERAGE case mentioned was based on viral loads where ppl were becoming symptomatic/testing once already at peak virus load & transmission always coming down

But now ppl are becoming symptomatic day 1 & day 4,5 may now be when ppl still at peak infectiousness

2/
I’m 1000% on board with cutting down isolation as much as possible

Heck - most ppl who tested positive in this pandemic on PCR over the past 2 years were already no longer infectious by the time they started isolation. I have argued that those ppl required 0 days isolation

3/
Read 6 tweets
29 Dec 21
NOTE:

This headline (From @US_FDA) is very likely NOT Accurate

Why?

1) Antigen Tests Detect a part of Omicron that isnt mutated

2) What the study identified is not that rapid tests are less sensitive - but simply that Omicron is more infectious

1/

politico.com/news/2021/12/2…
So what’s going on here?

When measured against a certain amount of virus, the tests perform equally well across all variants, including Omicron

2/
But, when asked how well do tests detect Omicron given an amount of “infectivity” in cells, tests were less sensitive for Omicron v Delta

Importantly, the issue isn’t the test!

Instead It shows a difference in Omicron infectiousness - and thus impacts ALL tests (PCR too)

3/
Read 8 tweets
27 Dec 21
CDC’s new guidance to drop isolation of positives to 5 days without a negative test is reckless

Some ppl stay infectious 3 days,Some 12

I absolutely don’t want to sit next to someone who turned Pos 5 days ago and hasnt tested Neg

Test Neg to leave isolation early is just smart
I am 100% for getting people to drop isolation early.

Heck, I formally recommended it to CDC in May 2020 and Published the recommendation in J of Clin Infectious Diseases in April 2020.

But it was always with a negative test.

What the heck are we doing here?

2/
This is the part that hurts the most. The reason they are doing this:

"The change is motivated by science demonstrating... SARS-CoV-2 transmission occurs... generally in the 1-2 days prior to onset of symptoms and the 2-3 days after"

That was BEFORE OMICRON.

3/
Read 12 tweets
26 Dec 21
Need rapid tests for travel or treatment or New Years or... but can't find them?

@eMedCertified allocated 1,000,000 for individuals to be able to obtain. Note, these are a proctored version that enable a lab result for travel & public health reporting

prnewswire.com/news-releases/…
Please note, I am now the Chief Science Officer of eMed.

I try to stay away from using this important platform for anything except informing on public health and science. However, I also will post when there is a good reason to about the company I am now CSO of.
Also, please note, eMed is NOT a test manufacturer but a live proctoring software company to authenticate and validate tests.

If you purchase tests via eMed (can also get them through Optum store I believe) what you are purchasing is live person proctoring - tests come with it
Read 4 tweets
24 Dec 21
The Solution

We need a new Pathway for Authorization at FDA

There are 3 primary bottlenecks in getting rapid tests authorized at FDA

None make sense biologically & remain for seemingly no reason but sheer stubbornness of FDA to not recognize this PUBLIC HEALTH EMERGENCY
🧵
1/
1) We do not allow much better data already collected in Europe to be used for immediate EUA of the very best tests in use by millions in Europe.

But We should! - many of them are better than most of ours available in the US

Could increase tests by 100’s of millions in days

2/
2) FDA requires Rapid Ag tests compared to entirely different technology, w entirely different analyte that diminishes in a very different time scale.

This causes MASSIVE slow downs and hurdles with clinical trials for EUA

Compare rapid tests to a gold standard rapid test!!

3/
Read 7 tweets
23 Dec 21
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

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