This is tremendously good news! (Thread)

@POTUS fully supporting scale up of rapid at-home tests

I've been arguing for this - the Defense Productions Act to be invoked since early last year to drive production of rapid tests

Testing in a pandemic is a Public Health need

1/
While I am tremendously happy to hear the President say this.

I do have my reservations:

Time is of the essence. If we start the scaling process now, it will take a long time.

Meanwhile many many tests exist globally. We could be using those for the time being.

2/
Importantly, I worry that the 280 million tests that are going to be purchased and produced with the use of the DPA... well, that's less than one test per person over the course of a year. The number sounds big but we do have 330 million ppl in US.

But it is a great start!

3/
The fact that this is on the president's radar as a major tool in this fight, and the interest to help get them out to people is a big step forward. My hope is that this still will allow the administration to see the benefits, for this pandemic and for future prepardness

4/
I do worry that the WH has not recognized perhaps THE fundamental problem that has limited widescale rapid testing in US. It's not the need for the DPA, but it's how we define these rapid tests that is causing us to fall so greatly behind many of our peer nations

5/
As long as these tests are regulated as medical devices, the FDA has to regulate them not as critical public health tools, but as medical tools, with all of the onerous clinical trials that slow everything down 100-fold.

6/
I was really hoping to hear @POTUS remark that from here on out, testing for COVID is a PUBLIC HEALTH tool and the regulatory requirements for PUBLIC HEALTH tools should be distinct from MEDICAL TOOLS.

THE CDC / NIH could evaluate and oversee

7/

As long as rapid tests are regulated as Medical Devices, FDA is compelled to compare them to Medical Devices (lab based PCR) for EUA

As I've discussed SO many times, this comparison doesn't make sense bc use of rapid tests in a pandemic is not medicine, it's public health

8/
For public health, the goal of rapid testing is detecting HIGH levels of virus to stop spread and to do so at low cost and in a highly accessible manner

For medicine, you want to detect even very LOW levels of virus to diagnose patients - not to protect patient's neighbors

9/
So, I do hope we can see our way to understanding that public health testing is not medicine and the regulatory environment, including the "gold-standard", should change for evaluation of a public health test.

10/

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More from @michaelmina_lab

11 Sep
Notes on sensitivity of rapid Ag tests for what matters: detecting infectious ppl

Sensitivity:

- Highly infectious (ie superspreader levels): >99%

- Moderately infectious (ie infect 2 or 3 ppl in a classroom): 90-95%

- Mildly infectious (ie spread to spouse only) ~80-90%

1/
This Graph of viral load over time helps to explain this sensitivity issue: Image
Further, symptoms vs no symptoms has no impact on test performance. Studies that say it does are not recognizing the sampling bias that enters their studies.

3/
Read 4 tweets
7 Sep
Dear @POTUS Biden,

The US is at a critical point & we need greater access to faster tests

Rapid tests are barely available bc they're regulated here as MEDICAL tools-holding them back

Please write an EO that makes COVID testing in US a Public Health good

Thanks
Ppl of the USA
These tests are regulated by FDA as medical devices. Which has greatly limited them!

For pandemic control UNDER AN EUA FOR A PUBLIC HEALTH EMERGENCY, rapid tests should be regulated as critical public health tools, vetted (appropriately) by CDC/NIH.
I had the opportunity to speak to the prior administration about this. Unfortunately it didn't go far despite many ppl trying.

I hope that an administration as forward looking as yours (@POTUS ) would see the benefit of an executive order that stops this deadly silliness.
Read 4 tweets
7 Sep
Did you know:

A test *not* performed has a sensitivity of 0% for symptomatic and asymptomatic ppl

A test w a 48 hr delay has 0% during the days of waiting

I talk a lot about sensitivity- but if we want to detect infectious people - frequency of testing is even more important.
And of course, the papers to back it up:

2/
nejm.org/doi/full/10.10…
And Test Sensitivity is secondary (way down the list) to frequency and turnaround time for using testing as a public health tool.

science.org/doi/10.1126/sc…
Read 5 tweets
7 Sep
Did you know

A test that is 100% accurate to detect infectious ppl will only *APPEAR* to be 30%-60% sensitive when compared to PCR-particularly asymptomatics

Why?

PCR stays positive LONG AFTER contagious period

for Public Health, PCR is NOT Specific - it’s a wrong comparison
Although rapid tests are not 100% sensitive to detect infectious levels of virus, they are >95% and do approach 100% for “superspreader” levels of virus.

We just (ignorantly) continue to compare them to PCR - which has led to massive confusion.

2/
This issue with PCR has caused us to isolate millions of ppl who were no longer infectious and lead contact tracers to trace and quarantine many many millions who were never exposed.

3/
Read 6 tweets
7 Sep
With all the news of vaccines & immunity, did you know measles infections destroy immunity and cause “Immune Amnesia”, increasing risk of all other infections

Our research in ‘15 & ‘19 discovered this & the abbreviated story is written up nicely here:

1/
medicalrepublic.com.au/the-great-meas…
In 2015, along w Bryan Grenfell and colleagues, we discovered an exceptionally strong relationship between measles epidemics and all cause childhood mortality - following outbreaks of measles, child mortality was increased for 2-3 years.

2/

science.org/doi/abs/10.112…
We hypothesized then that measles was destroying B cells and plasma cells responsible for retaining immune memory. This is bc the measles virus specifically attacks immune memory cells via attachment to CD150 - a protein enriched on memory cells.

3/

nature.com/articles/ni010…

3/
Read 10 tweets
4 Sep
I’ll say it again:

Rapid tests have the same accuracy in asymptomatics as symptomatics

If someone says they are less sensitive to detect infectious people who are asymptomatic, they are wrong

The test does not care about your symptoms, it cares about how much virus you have
The above comment is referring to “same accuracy to identify infectious individuals”.

The reason numerous papers say they are less accurate in asymptomatics is because of sampling bias. Asymptomatics are much more frequently tested *AFTER* they are no longer infectious.
s PCR remains positive for weeks, meanwhile infectiousness lasts only 3-7 days - and thus rapid tests are only positive for 3-7 days or About 30% of the time that ppl are PCR positive.

4/
Read 4 tweets

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